Trial Outcomes & Findings for COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine (NCT NCT00466947)

NCT ID: NCT00466947

Last Updated: 2019-07-16

Results Overview

A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (\>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 23802 participants
• Primary outcome timeframe: Any time from 2 weeks after Dose 3 up to 31 August 2010
• Results posted on: 2019-07-16

Participant Flow

Analysis on the primary outcome was performed when at least 535 first bacterial CAP episodes were reported from 2 weeks after vaccine Dose 3 (31 August 2010) with 23738 subjects (11875 and 11863 in Synflorix and Control groups) and analysis at study end was performed on 23597 subjects.

Participant milestones

Measure	Synflorix Group Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Primary Outcome Analysis Period STARTED	11875	11863
Primary Outcome Analysis Period Ongoing	11875	11863
Primary Outcome Analysis Period COMPLETED	0	0
Primary Outcome Analysis Period NOT COMPLETED	11875	11863
Study End Analysis Period STARTED	11798	11799
Study End Analysis Period COMPLETED	9302	9265
Study End Analysis Period NOT COMPLETED	2496	2534

Reasons for withdrawal

Measure	Synflorix Group Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Primary Outcome Analysis Period Other: study still ongoing	11875	11863
Study End Analysis Period Adverse Event	35	43
Study End Analysis Period Lost to Follow-up	1137	1167
Study End Analysis Period Physician Decision	29	29
Study End Analysis Period Protocol Violation	9	17
Study End Analysis Period Withdrawal by Subject	1264	1267
Study End Analysis Period Other - Forbidden vaccination	21	10
Study End Analysis Period Other - Subject without a legal guardian	1	0
Study End Analysis Period Other - Unconformity in team's treatment	0	1

Baseline Characteristics

COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine

Baseline characteristics by cohort

Measure	Synflorix Group n=11798 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=11799 Participants Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.	Total n=23597 Participants Total of all reporting groups
Age, Continuous	9.2 Weeks STANDARD_DEVIATION 1.93 • n=5 Participants	9.2 Weeks STANDARD_DEVIATION 1.92 • n=7 Participants	9.2 Weeks STANDARD_DEVIATION 1.92 • n=5 Participants
Sex: Female, Male Female	5796 Participants n=5 Participants	5767 Participants n=7 Participants	11563 Participants n=5 Participants
Sex: Female, Male Male	6002 Participants n=5 Participants	6032 Participants n=7 Participants	12034 Participants n=5 Participants
Region of Enrollment Argentina	6990 Subjects n=5 Participants	6991 Subjects n=7 Participants	13981 Subjects n=5 Participants
Region of Enrollment Columbia	1206 Subjects n=5 Participants	1196 Subjects n=7 Participants	2402 Subjects n=5 Participants
Region of Enrollment Panama	3602 Subjects n=5 Participants	3612 Subjects n=7 Participants	7214 Subjects n=5 Participants

PRIMARY outcome

Timeframe: Any time from 2 weeks after Dose 3 up to 31 August 2010

Population: Analysis was performed on the Interim ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of 31 August 2010.

A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.

Outcome measures

Measure	Synflorix Group n=10295 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10201 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)	240 Subjects	304 Subjects

SECONDARY outcome

Timeframe: Throughout the study (Month 0 to Month 22-25)

Population: The analysis was performed on all vaccinated subjects whose data were exploited towards analysis of results at the end of the study.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Synflorix Group n=11798 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=11799 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Serious Adverse Events (SAEs)	2534 Subjects	2668 Subjects

SECONDARY outcome

Timeframe: Throughout the study (Month 0 to Month 22-25)

Population: The analysis was performed on all vaccinated subjects included in the Panama subset.

An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama.

Outcome measures

Measure	Synflorix Group n=3602 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=3612 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset	3530 Subjects	3518 Subjects

SECONDARY outcome

Timeframe: Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration

Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.

Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.

Outcome measures

Measure	Synflorix Group n=368 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Pain after vaccination with Synflorix	275 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Pain after vaccination with Infanrix Hexa	270 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Redness after vaccination with Synflorix	182 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Redness after vaccination with Infanrix Hexa	171 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Swelling after vaccination with Synflorix	141 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Swelling after vaccination with Infanrix Hexa	143 Subjects	—

SECONDARY outcome

Timeframe: Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration

Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.

Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.

Outcome measures

Measure	Synflorix Group n=317 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Pain after vaccination with Synflorix	129 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Pain after vaccination with Infanrix-IPV/Hib	131 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Redness after vaccination with Synflorix	104 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Redness after vaccination with Infanrix-IPV/Hib	98 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Swelling after vaccination with Synflorix	74 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Swelling after vaccination with Infanrix-IPV/Hib	69 Subjects	—

SECONDARY outcome

Timeframe: Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration

Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.

Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.

Outcome measures

Measure	Synflorix Group n=357 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Pain after vaccination with Engerix	165 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Redness after vaccination with Infanrix-IPV/Hib	118 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Redness after vaccination with Engerix	109 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Swelling after vaccination with Infanrix-IPV/Hib	98 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Swelling after vaccination with Engerix	91 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Pain after vaccination with Infanrix-IPV/Hib	169 Subjects	—

SECONDARY outcome

Timeframe: Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration.

Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.

Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.

Outcome measures

Measure	Synflorix Group n=303 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group Redness after vaccination with Havrix	73 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group Swelling after vaccination with Infanrix-IPV/Hib	70 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group Swelling after vaccination with Havrix	55 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group Pain after vaccination with Infanrix-IPV/Hib	81 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group Pain after vaccination with Havrix	89 Subjects	—
Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group Redness after vaccination with Infanrix-IPV/Hib	81 Subjects	—

SECONDARY outcome

Timeframe: Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration

Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.

Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=368 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=357 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Fever (rectal temperature >= 38°C)	247 Subjects	125 Subjects
Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Irritability	289 Subjects	206 Subjects
Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Loss of appetite	133 Subjects	80 Subjects
Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset Drowsiness	236 Subjects	168 Subjects

SECONDARY outcome

Timeframe: Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration

Population: The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.

Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=317 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=303 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Drowsiness	74 Subjects	65 Subjects
Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Fever (rectal temperature >= 38°C)	93 Subjects	73 Subjects
Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Irritability	121 Subjects	95 Subjects
Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset Loss of appetite	51 Subjects	46 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks after Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

The Panama Subset contained all subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=3010 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=2979 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset	204 Subjects	239 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP)	181 Subjects	231 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

The Panama Subset contained all subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=3010 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=2979 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset	32 Subjects	45 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=3010 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=2979 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset	6 Subjects	18 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=3010 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=2979 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset.	3 Subjects	4 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=3010 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=2979 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset.	3 Subjects	4 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

The Panama Subset contained all subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=3010 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=2979 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset	12 Subjects	14 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

The Panama Subset contained all subjects enrolled in Panama

Outcome measures

Measure	Synflorix Group n=3010 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=2979 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset	12 Subjects	14 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=3010 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=2979 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset	8 Subjects	7 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT)	21 Subjects	25 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

An "abnormal CXR" was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT)	104 Subjects	112 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT).	35 Subjects	39 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP)	2108 Subjects	2237 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

An "abnormal CXR" was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR)	681 Subjects	764 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading S-CAP with CRP >= 120 mg/L regardless of CXR exam	85 Subjects	119 Subjects
Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading S-CAP with CRP >= 40 mg/L regardless of CXR exam	425 Subjects	499 Subjects
Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading S-CAP with CRP >= 80 mg/L regardless of CXR exam	175 Subjects	237 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off. C-CAP or NAI-CAP with CRP >= 80 mg/L	208 Subjects	256 Subjects
Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off. C-CAP or NAI-CAP with CRP >= 120 mg/L	191 Subjects	240 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD).	0 Subjects	16 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID).	6 Subjects	17 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID)	6 Subjects	17 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes.	2 Subjects	1 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Population: Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of study end.

The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8.

Outcome measures

Measure	Synflorix Group n=10211 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=10140 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes.	3 Subjects	0 Subjects

SECONDARY outcome

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

No subject was reported with any case of ID due to Haemophilus influenzae.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25

Population: The analysis was performed on all vaccinated subjects included in the carriage subset.

The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=814 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=814 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 5 (N=814; 814)	104 Subjects	123 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 10-13 (N=788; 784)	92 Subjects	123 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 13-16 (N=758; 762)	88 Subjects	109 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 16-19 (N=696; 690)	68 Subjects	98 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 22-25 (N=627; 639)	61 Subjects	86 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 14-17 (N=720; 738)	74 Subjects	103 Subjects

SECONDARY outcome

Timeframe: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25

Population: The analysis was performed on all vaccinated subjects included in the carriage subset.

Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=814 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=814 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 10-13 (N=788; 784)	81 Subjects	63 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 13-16 (N=758; 762)	57 Subjects	63 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 16-19 (N=696; 690)	55 Subjects	57 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 22-25 (N=627; 639)	38 Subjects	46 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 5 (N=814; 814)	63 Subjects	67 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 14-17 (N=720; 738)	57 Subjects	49 Subjects

SECONDARY outcome

Timeframe: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25

Population: The analysis was performed on all vaccinated subjects included in the carriage subset.

S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=814 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=814 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset Month 5 (N=814; 814)	99 Subjects	86 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset Month 16-19 (N=696; 690)	89 Subjects	69 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset Month 10-13 (N=788; 784)	85 Subjects	85 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset Month 13-16 (N=758; 762)	83 Subjects	85 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset Month 14-17 (N=720; 738)	78 Subjects	85 Subjects
Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset Month 22-25 (N=627; 639)	74 Subjects	61 Subjects

SECONDARY outcome

Timeframe: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25

Population: The analysis was performed on all vaccinated subjects included in the carriage subset.

Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=824 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=820 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 10-13 (N=788;785)	45 Subjects	44 Subjects
Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 13-16 (N=757;762)	32 Subjects	39 Subjects
Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 14-17 (N=720; 737)	28 Subjects	34 Subjects
Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 5 (N=824; 820)	36 Subjects	40 Subjects
Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 16-19 (N=696; 690)	28 Subjects	38 Subjects
Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 22-25 (N=628; 640)	29 Subjects	33 Subjects

SECONDARY outcome

Timeframe: At Months 10-13, 13-16, 14-17, 16-19 and 22-25

Population: The analysis was performed on all vaccinated subjects included in the carriage subset.

The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=788 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=784 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 14-17 (N=720;738)	110 Subjects	137 Subjects
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 10-13 (N=788;784)	171 Subjects	175 Subjects
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 13-16 (N=758;762)	145 Subjects	165 Subjects
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 16-19 (N=696;690)	126 Subjects	137 Subjects
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset Month 22-25;N=627;639)	123 Subjects	124 Subjects

SECONDARY outcome

Timeframe: At Months 10-13, 13-16, 14-17, 16-19 and 22-25

Population: The analysis was performed on all vaccinated subjects included in the carriage subset.

The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=788 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=785 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 10-13 (N=788;785)	39 Subjects	37 Subjects
Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 13-16 (N=757;762)	27 Subjects	33 Subjects
Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 14-17 (N=720;737)	23 Subjects	28 Subjects
Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 16-19 (N=696;690)	22 Subjects	32 Subjects
Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset. Month 22-25 (N=628;640)	28 Subjects	31 Subjects

SECONDARY outcome

Timeframe: Throughout the study (Month 0 to Month 22-25)

Population: The analysis was performed on all vaccinated subjects included in the carriage subset.

The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.

Outcome measures

Measure	Synflorix Group n=955 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=966 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset.	611 Subjects	626 Subjects

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=334 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=331 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-1 (N=334;312)	2.51 µg/mL Interval 2.29 to 2.75	0.04 µg/mL Interval 0.03 to 0.04
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-4 (N=334;328)	3.26 µg/mL Interval 2.98 to 3.56	0.03 µg/mL Interval 0.03 to 0.04
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANITI-6B (N=334;322)	1.34 µg/mL Interval 1.18 to 1.52	0.03 µg/mL Interval 0.03 to 0.03
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-9V (N=334;331)	3.15 µg/mL Interval 2.84 to 3.5	0.04 µg/mL Interval 0.03 to 0.04
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-18C (N=334;328)	5.32 µg/mL Interval 4.73 to 5.99	0.04 µg/mL Interval 0.04 to 0.04
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-23F (N=334;331)	1.99 µg/mL Interval 1.76 to 2.26	0.04 µg/mL Interval 0.03 to 0.04
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-7F (N=334;330)	3.86 µg/mL Interval 3.56 to 4.19	0.04 µg/mL Interval 0.04 to 0.05
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-14 (N=334;330)	4.55 µg/mL Interval 4.07 to 5.1	0.09 µg/mL Interval 0.08 to 0.11
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-19F (N=334;327)	5.33 µg/mL Interval 4.7 to 6.06	0.06 µg/mL Interval 0.05 to 0.07
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-5 (N=334;324)	4.20 µg/mL Interval 3.86 to 4.57	0.05 µg/mL Interval 0.04 to 0.05

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=334 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=326 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset ANTI-6A (N=334;321)	0.32 µg/mL Interval 0.27 to 0.37	0.03 µg/mL Interval 0.03 to 0.04
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset ANTI-19A (N=334;326)	0.29 µg/mL Interval 0.25 to 0.33	0.04 µg/mL Interval 0.04 to 0.05

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=231 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=214 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-1, M1 POST-BST (N=219;196)	3.58 µg/mL Interval 3.15 to 4.07	0.06 µg/mL Interval 0.05 to 0.06
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-1, M9 POST-BST (N=206;181)	0.65 µg/mL Interval 0.56 to 0.75	0.06 µg/mL Interval 0.05 to 0.06
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-4, M9 POST-BST (N=206;183)	0.87 µg/mL Interval 0.77 to 0.99	0.04 µg/mL Interval 0.04 to 0.05
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-5, PRE (N=231;209)	0.90 µg/mL Interval 0.8 to 1.01	0.07 µg/mL Interval 0.07 to 0.09
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-5, M1 POST-BST (N=219;199)	5.73 µg/mL Interval 5.04 to 6.5	0.07 µg/mL Interval 0.06 to 0.08
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-5, M9 POST-BST (N=206;182)	1.19 µg/mL Interval 1.05 to 1.36	0.09 µg/mL Interval 0.08 to 0.1
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-6B, PRE (N=229;212)	0.55 µg/mL Interval 0.47 to 0.64	0.04 µg/mL Interval 0.03 to 0.04
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-6B, M1 POST-BST (N=217;198)	3.32 µg/mL Interval 2.92 to 3.77	0.04 µg/mL Interval 0.03 to 0.04
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-6B, M9 POST-BST (N=206;182)	0.83 µg/mL Interval 0.71 to 0.96	0.05 µg/mL Interval 0.04 to 0.06
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-7F, M1 POST-BST (N=218;198)	5.77 µg/mL Interval 5.23 to 6.36	0.06 µg/mL Interval 0.05 to 0.07
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-7F, M9 POST-BST (N=206;182)	1.32 µg/mL Interval 1.19 to 1.45	0.07 µg/mL Interval 0.05 to 0.08
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-9V, PRE (N=230;214)	1.14 µg/mL Interval 1.0 to 1.31	0.04 µg/mL Interval 0.04 to 0.05
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-9V, M9 POST-BST (N=206;182)	1.80 µg/mL Interval 1.59 to 2.03	0.05 µg/mL Interval 0.04 to 0.06
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-14, PRE (N=231;214)	1.15 µg/mL Interval 1.15 to 1.35	0.11 µg/mL Interval 0.09 to 0.13
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-14, M1 POST-BST (N=219;200)	9.31 µg/mL Interval 8.18 to 10.6	0.12 µg/mL Interval 0.1 to 0.14
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-14, M9 POST-BST (N=206;183)	1.98 µg/mL Interval 1.74 to 2.26	0.17 µg/mL Interval 0.14 to 0.21
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-18C, PRE (N=231;210)	0.90 µg/mL Interval 0.79 to 1.03	0.05 µg/mL Interval 0.04 to 0.06
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-18C, M9 POST-BST (N=206;181)	2.50 µg/mL Interval 2.21 to 2.83	0.05 µg/mL Interval 0.04 to 0.06
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-19F, PRE (N=231;206)	1.27 µg/mL Interval 1.09 to 1.48	0.06 µg/mL Interval 0.05 to 0.07
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-19F, M1 POST-BST (N=219;198)	9.40 µg/mL Interval 8.4 to 10.52	0.07 µg/mL Interval 0.05 to 0.08
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-23F, PRE (N=229;204)	0.62 µg/mL Interval 0.53 to 0.72	0.04 µg/mL Interval 0.03 to 0.05
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-23F, M1 POST-BST (N=218;201)	4.02 µg/mL Interval 3.49 to 4.62	0.04 µg/mL Interval 0.03 to 0.04
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-23F, M9 POST-BST (N=206;179)	0.92 µg/mL Interval 0.8 to 1.06	0.05 µg/mL Interval 0.04 to 0.06
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-1, PRE (N=231;203)	0.35 µg/mL Interval 0.31 to 0.39	0.05 µg/mL Interval 0.04 to 0.06
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-4, PRE (N=231;214)	0.48 µg/mL Interval 0.42 to 0.55	0.04 µg/mL Interval 0.04 to 0.05
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-4, M1 POST-BST (N=217;204)	6.55 µg/mL Interval 5.81 to 7.38	0.05 µg/mL Interval 0.04 to 0.05
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-7F, PRE (N=231;210)	0.94 µg/mL Interval 0.84 to 1.04	0.06 µg/mL Interval 0.05 to 0.07
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-9V, M1 POST-BST (N=218;203)	7.34 µg/mL Interval 6.51 to 8.27	0.04 µg/mL Interval 0.04 to 0.05
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-18C, M1 POST-BST (N=219;203)	16.38 µg/mL Interval 14.47 to 18.55	0.05 µg/mL Interval 0.04 to 0.05
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset. ANTI-19F, M9 POST-BST (N=205;181)	2.47 µg/mL Interval 2.16 to 2.84	0.10 µg/mL Interval 0.08 to 0.12

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=231 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=214 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset ANTI-19A, M1 POST-BST (N=218;201)	1.34 µg/mL Interval 1.11 to 1.62	0.06 µg/mL Interval 0.05 to 0.07
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset ANTI-19A, M9 POST-BST (N=206;181)	0.54 µg/mL Interval 0.46 to 0.65	0.09 µg/mL Interval 0.07 to 0.11
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset ANTI-6A, PRE (N=231;214)	0.22 µg/mL Interval 0.18 to 0.26	0.04 µg/mL Interval 0.04 to 0.05
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset ANTI-6A, M1 POST-BST (N=219;204)	1.14 µg/mL Interval 0.93 to 1.4	0.04 µg/mL Interval 0.03 to 0.04
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset ANTI-6A, M9 POST-BST (N=206;183)	0.31 µg/mL Interval 0.26 to 0.37	0.05 µg/mL Interval 0.04 to 0.06
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset ANTI-19A, PRE (N=229;212)	0.25 µg/mL Interval 0.21 to 0.3	0.05 µg/mL Interval 0.05 to 0.07

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=334 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=331 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-4 (N=334;328)	332 Subjects	11 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANITI-6B (N=334;322)	311 Subjects	8 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-7F (N=334;330)	333 Subjects	28 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-9V (N=334;331)	330 Subjects	19 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-23F (N=334;331)	321 Subjects	15 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-1 (N=334;312)	333 Subjects	13 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-5 (N=334;324)	333 Subjects	22 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-14 (N=334;330)	328 Subjects	77 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-18C (N=334;328)	330 Subjects	21 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19F (N=334;327)	325 Subjects	40 Subjects

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=334 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=326 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6A (N=334;321)	215 Subjects	5 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19A (N=334;326)	204 Subjects	18 Subjects

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed with the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=231 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=214 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-1, PRE (N=231;203)	164 Subjects	14 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-4, PRE (N=231;214)	190 Subjects	26 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-4, M1 POST-BST (N=217;204)	217 Subjects	24 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-5, PRE (N=231;209)	218 Subjects	27 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-5, M1 POST-BST (N=219;199)	219 Subjects	30 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-5, M9 POST-BST (N=206;182)	200 Subjects	34 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6B, M1 POST-BST (N=217;198)	215 Subjects	13 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6B, M9 POST-BST (N=206;182)	192 Subjects	21 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-7F, PRE (N=231;210)	222 Subjects	34 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-7F, M1 POST-BST (N=218;198)	218 Subjects	36 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-7F, M9 POST-BST (N=206;182)	205 Subjects	31 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-9V, PRE (N=230;214)	221 Subjects	22 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-18C, M1 POST-BST (N=219;203)	219 Subjects	21 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19F, M9 POST-BST (N=205;181)	204 Subjects	52 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-23F, PRE (N=229;204)	198 Subjects	15 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-1, M1 POST-BST (N=219;196)	219 Subjects	19 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-1, M9 POST-BST (N=206;181)	186 Subjects	14 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-4, M9 POST-BST (N=206;183)	198 Subjects	15 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6B, PRE (N=229;212)	182 Subjects	12 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-9V, M1 POST-BST (N=218;203)	218 Subjects	14 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-9V, M9 POST-BST (N=206;182)	206 Subjects	26 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-14, PRE (N=231;214)	217 Subjects	51 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-14, M1 POST-BST (N=219;200)	219 Subjects	52 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-14, M9 POST-BST (N=206;183)	204 Subjects	68 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-18C, PRE (N=231;210)	217 Subjects	22 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-18C, M9 POST-BST (N=206;181)	205 Subjects	18 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19F, PRE (N=231;206)	221 Subjects	35 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19F, M1 POST-BST (N=219;198)	218 Subjects	39 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-23F, M1 POST-BST (N=218;201)	216 Subjects	14 Subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-23F, M9 POST-BST (N=206;179)	196 Subjects	25 Subjects

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=231 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=214 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6A, PRE (N=231;214)	119 Subjects	14 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6A, M1 POST-BST (N=219;204)	187 Subjects	12 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6A, M9 POST-BST (N=206;183)	129 Subjects	24 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19A, PRE (N=229;212)	131 Subjects	28 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19A, M1 POST-BST (N=218;201)	197 Subjects	27 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19A, M9 POST-BST (N=206;181)	165 Subjects	47 Subjects

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=334 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=331 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-1 (N=334;312)	333 Subjects	88 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-9V (N=334;331)	331 Subjects	68 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-14 (N=334;330)	333 Subjects	234 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-23F (N=334;331)	328 Subjects	78 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-4 (N=334;328)	333 Subjects	48 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-5 (N=334;324)	334 Subjects	153 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANITI-6B (N=334;322)	324 Subjects	48 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-7F (N=334;330)	333 Subjects	116 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-18C (N=334;328)	333 Subjects	92 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19F (N=334;327)	331 Subjects	176 Subjects

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=334 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=326 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset ANTI-6A (N=334;321)	306 Subjects	77 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset ANTI-19A (N=334;326)	303 Subjects	120 Subjects

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=231 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=214 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-1, M1 POST-BST (N=219;196)	219 Subjects	101 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-1, M9 POST-BST (N=206;181)	206 Subjects	95 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-1, PRE (N=231;203)	231 Subjects	87 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-4, PRE (N=231;214)	231 Subjects	52 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-4, M1 POST-BST (N=217;204)	217 Subjects	65 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-4, M9 POST-BST (N=206;183)	206 Subjects	58 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-5, PRE (N=231;209)	231 Subjects	150 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-5, M1 POST-BST (N=219;199)	219 Subjects	142 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-5, M9 POST-BST (N=206;182)	206 Subjects	133 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6B, PRE (N=229;212)	226 Subjects	60 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6B, M1 POST-BST (N=217;198)	216 Subjects	54 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-6B, M9 POST-BST (N=206;182)	206 Subjects	72 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-7F, PRE (N=231;210)	231 Subjects	79 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-7F, M1 POST-BST (N=218;198)	218 Subjects	79 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-7F, M9 POST-BST (N=206;182)	206 Subjects	87 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-9V, PRE (N=230;214)	230 Subjects	51 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-9V, M1 POST-BST (N=218;203)	218 Subjects	58 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-9V, M9 POST-BST (N=206;182)	206 Subjects	68 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-18C, M1 POST-BST (N=219;203)	219 Subjects	71 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-18C, M9 POST-BST (N=206;181)	206 Subjects	73 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19F, PRE (N=231;206)	231 Subjects	71 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19F, M1 POST-BST (N=219;198)	219 Subjects	85 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-19F, M9 POST-BST (N=205;181)	205 Subjects	93 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-23F, PRE (N=229;204)	223 Subjects	44 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-14, PRE (N=231;214)	231 Subjects	157 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-14, M1 POST-BST (N=219;200)	219 Subjects	160 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-14, M9 POST-BST (N=206;183)	206 Subjects	154 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-18C, PRE (N=231;210)	230 Subjects	72 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-23F, M1 POST-BST (N=218;201)	216 Subjects	44 Subjects
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset ANTI-23F, M9 POST-BST (N=206;179)	206 Subjects	62 Subjects

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) .

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=231 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=214 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset ANTI-6A, PRE (N=231;214)	210 Subjects	61 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset ANTI-6A, M1 POST-BST (N=219;204)	214 Subjects	61 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset ANTI-6A, M9 POST-BST (N=206;183)	196 Subjects	69 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset ANTI-19A, PRE (N=229;212)	208 Subjects	76 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset ANTI-19A, M1 POST-BST (N=218;201)	212 Subjects	83 Subjects
Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset ANTI-19A, M9 POST-BST (N=206;181)	201 Subjects	89 Subjects

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination,

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=317 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=317 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-1 (N=306;305)	139.5 Titers Interval 116.8 to 166.5	4.8 Titers Interval 4.5 to 5.3
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-4 (N=310;299)	771.7 Titers Interval 686.5 to 867.6	5.1 Titers Interval 4.5 to 5.8
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-5 (N=313;314)	224.8 Titers Interval 196.0 to 257.8	4.5 Titers Interval 4.2 to 4.8
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-6B (N=315;309)	689.7 Titers Interval 553.2 to 859.7	5.4 Titers Interval 4.6 to 6.2
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-7F (N=302;266)	4656.7 Titers Interval 4175.6 to 5193.3	110.4 Titers Interval 78.8 to 154.7
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-9V (N=312;302)	1690.4 Titers Interval 1489.4 to 1918.7	14.6 Titers Interval 11.6 to 18.2
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-14 (N=308;273)	908.5 Titers Interval 795.2 to 1038.1	16.5 Titers Interval 12.9 to 21.1
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-18C (N=308;317)	310.9 Titers Interval 259.4 to 372.6	4.4 Titers Interval 4.1 to 4.7
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-19F (N=304;314)	383.0 Titers Interval 308.5 to 475.5	4.7 Titers Interval 4.3 to 5.2
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-23F (N=317;282)	2167.4 Titers Interval 1863.4 to 2521.1	14.5 Titers Interval 11.0 to 19.1

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=302 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=309 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset OPSONO-6A (N=297;305)	156.9 Titers Interval 121.8 to 202.1	5.0 Titers Interval 4.5 to 5.5
Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset OPSONO-19A (N=302;309)	18.2 Titers Interval 14.5 to 22.9	4.1 Titers Interval 4.0 to 4.3

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=221 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=210 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-1, M1 POST-BST (N=209;200)	357.5 Titers Interval 281.8 to 453.5	4.8 Titers Interval 4.4 to 5.4
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-1, M9 POST-BST (N=196;176)	34.4 Titers Interval 26.6 to 44.7	4.6 Titers Interval 4.2 to 5.1
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-4, PRE (N=208;193)	29.2 Titers Interval 21.2 to 40.2	8.6 Titers Interval 6.4 to 11.5
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-4, M1 POST-BST (N=207;193)	2853.5 Titers Interval 2365.5 to 3442.1	8.3 Titers Interval 6.3 to 10.9
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-4, M9 POST-BST (N=192;173)	165.6 Titers Interval 115.3 to 237.9	8.1 Titers Interval 6.1 to 10.8
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-5, PRE (N=205;204)	18.5 Titers Interval 15.4 to 22.3	4.3 Titers Interval 4.1 to 4.6
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-5, M1 POST-BST (N=196;187)	306.1 Titers Interval 252.0 to 371.8	4.4 Titers Interval 4.1 to 4.7
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-5, M9 POST-BST (N=192;173)	44.1 Titers Interval 35.5 to 54.7	4.2 Titers Interval 4.0 to 4.4
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-6B, PRE (N=209;197)	95.5 Titers Interval 70.1 to 130.1	7.6 Titers Interval 6.0 to 9.8
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-6B, M1 POST-BST (N=203;190)	1123.4 Titers Interval 939.2 to 1343.9	7.1 Titers Interval 5.6 to 8.9
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-6B, M9 POST-BST (N=178;165)	128.9 Titers Interval 92.7 to 179.2	11.4 Titers Interval 8.3 to 15.8
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-7F, PRE (N=217;202)	1522.8 Titers Interval 1338.5 to 1732.6	979.5 Titers Interval 821.2 to 1168.5
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-7F, M1 POST-BST (N=205;196)	4336.3 Titers Interval 3607.9 to 5211.8	746.4 Titers Interval 590.7 to 943.1
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-7F, M9 POST-BST (N=192;172)	2598.0 Titers Interval 2232.0 to 3024.1	1214.3 Titers Interval 1011.4 to 1458.0
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-9V, PRE (N=213;188)	709.4 Titers Interval 601.7 to 836.3	233.7 Titers Interval 175.3 to 311.4
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-9V, M1 POST-BST (N=200;189)	3763.0 Titers Interval 3317.5 to 4268.3	250.9 Titers Interval 186.1 to 338.4
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-9V, M9 POST-BST (N=194;168)	1320.3 Titers Interval 1153.1 to 1511.7	337.4 Titers Interval 252.4 to 451.0
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-14, PRE (N=205;192)	121.2 Titers Interval 89.7 to 163.8	27.0 Titers Interval 18.9 to 38.5
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-14, M1 POST-BST (N=209;188)	2659.6 Titers Interval 2266.2 to 3121.3	21.7 Titers Interval 15.0 to 31.2
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-14, M9 POST-BST (N=185;159)	330.6 Titers Interval 242.7 to 450.5	27.6 Titers Interval 18.3 to 41.8
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-18C, PRE (N=204;191)	15.0 Titers Interval 11.5 to 19.6	4.8 Titers Interval 4.2 to 5.4
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-18C, M1 POST-BST (N=188;187)	2426.0 Titers Interval 2041.8 to 2882.5	5.2 Titers Interval 4.4 to 6.0
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-18C, M9 POST-BST (N=170;164)	722.0 Titers Interval 553.6 to 941.6	5.3 Titers Interval 4.4 to 6.5
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-19F, M1 POST-BST (N=199;200)	657.5 Titers Interval 497.4 to 869.1	5.0 Titers Interval 4.4 to 5.7
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-19F, M9 POST-BST (N=194;170)	118.0 Titers Interval 90.6 to 153.7	4.8 Titers Interval 4.3 to 5.4
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-23F, PRE (N=215;199)	679.3 Titers Interval 494.3 to 933.6	76.9 Titers Interval 49.0 to 120.6
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-23F, M1 POST-BST (N=206;190)	4278.3 Titers Interval 3609.3 to 5071.3	99.7 Titers Interval 62.7 to 158.6
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-23F, M9 POST-BST (N=187;167)	999.6 Titers Interval 711.8 to 1403.9	109.4 Titers Interval 65.7 to 182.2
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-1, PRE (N=221;210)	9.0 Titers Interval 7.4 to 10.9	4.6 Titers Interval 4.2 to 5.0
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset OPSONO-19F, PRE (N=218;205)	24.3 Titers Interval 19.6 to 30.1	5.0 Titers Interval 4.4 to 5.7

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=217 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=204 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset OPSONO-6A, PRE (N=189;194)	43.8 Titers Interval 31.0 to 62.0	7.1 Titers Interval 5.7 to 8.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset OPSONO-6A, M1 POST BST (N=185;185)	277.2 Titers Interval 198.7 to 386.7	7.6 Titers Interval 6.0 to 9.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset OPSONO-6A, M9 POST-BST (N=175;156)	63.9 Titers Interval 44.3 to 92.0	17.2 Titers Interval 12.1 to 24.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset OPSONO-19A, PRE (N=217;204)	6.3 Titers Interval 5.3 to 7.4	5.0 Titers Interval 4.4 to 5.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset OPSONO-19A, M1 POST-BST (N=200;197)	132.8 Titers Interval 97.5 to 180.8	5.4 Titers Interval 4.7 to 6.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset OPSONO-19A, M9 POST-BST (N=187;171)	26.1 Titers Interval 19.5 to 35.1	6.3 Titers Interval 5.3 to 7.5

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=317 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=317 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-1 (N=306;305)	280 Subjects	25 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-4 (N=310;299)	306 Subjects	15 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-5 (N=313;314)	303 Subjects	13 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-6B (N=315;309)	286 Subjects	16 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-7F (N=302;266)	302 Subjects	162 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-9V (N=312;302)	311 Subjects	98 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-14 (N=308;273)	306 Subjects	95 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-18C (N=308;317)	290 Subjects	8 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-19F (N=304;314)	277 Subjects	16 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset OPSONO-23F (N=317;282)	311 Subjects	68 Subjects

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=302 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=309 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset OPSONO-6A (N=297;305)	232 Subjects	16 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset OPSONO-19A (N=302;309)	121 Subjects	5 Subjects

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=221 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=210 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-1, PRE (N=221;210)	58 Subjects	9 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-1, M1 POST-BST (N=209;200)	195 Subjects	14 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-1, M9 POST-BST (N=196;176)	127 Subjects	10 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-4, PRE (N=208;193)	108 Subjects	25 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-4, M1 POST-BST (N=207;193)	206 Subjects	26 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-4, M9 POST-BST (N=192;173)	147 Subjects	22 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-5, PRE (N=205;204)	138 Subjects	7 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-5, M1 POST-BST (N=196;187)	194 Subjects	10 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-5, M9 POST-BST (N=192;173)	157 Subjects	3 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-6B, PRE (N=209;197)	162 Subjects	27 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-6B, M1 POST-BST (N=203;190)	200 Subjects	23 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-6B, M9 POST-BST (N=178;165)	146 Subjects	35 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-7F, PRE (N=217;202)	217 Subjects	197 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-7F, M1 POST-BST (N=205;196)	203 Subjects	185 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-7F, M9 POST-BST (N=192;172)	192 Subjects	169 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-9V, PRE (N=213;188)	212 Subjects	159 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-9V, M1 POST-BST (N=200;189)	200 Subjects	157 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-9V, M9 POST-BST (N=194;168)	194 Subjects	148 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-14, PRE (N=205;192)	158 Subjects	73 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-14, M1 POST-BST (N=209;188)	208 Subjects	61 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-14, M9 POST-BST (N=185;159)	160 Subjects	57 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-18C, PRE (N=204;191)	86 Subjects	8 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-18C, M1 POST-BST (N=188;187)	187 Subjects	11 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-18C, M9 POST-BST (N=170;164)	165 Subjects	10 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-19F, PRE (N=218;205)	150 Subjects	14 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-19F, M1 POST-BST (N=199;200)	186 Subjects	13 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-19F, M9 POST-BST (N=194;170)	168 Subjects	11 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-23F, PRE (N=215;199)	190 Subjects	94 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-23F, M1 POST-BST (N=206;190)	205 Subjects	97 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset OPSONO-23F, M9 POST-BST (N=187;167)	167 Subjects	85 Subjects

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST).

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=217 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=204 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset OPSONO-6A, PRE (N=189;194)	99 Subjects	24 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset OPSONO-6A, M9 POST-BST (N=175;156)	104 Subjects	50 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset OPSONO-19A, PRE (N=217;204)	32 Subjects	14 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset OPSONO-19A, M1 POST-BST (N=200;197)	161 Subjects	20 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset OPSONO-19A, M9 POST-BST (N=187;171)	108 Subjects	32 Subjects
Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset OPSONO-6A, M1 POST BST (N=185;185)	150 Subjects	26 Subjects

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=334 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=325 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset	2455.2 EL.U/mL Interval 2248.3 to 2681.1	101.2 EL.U/mL Interval 91.3 to 112.2

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST)

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=230 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=211 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset ANTI-PD, PRE (N=230;211)	638.6 EL.U/mL Interval 556.2 to 733.2	103.1 EL.U/mL Interval 90.5 to 117.5
Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset ANTI-PD, M1 POST BST (N=218;195)	2787.0 EL.U/mL Interval 2435.9 to 3188.7	92.4 EL.U/mL Interval 82.6 to 103.3
Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset ANTI-PD, M9 POST-BST (N=206;182)	824.1 EL.U/mL Interval 704.2 to 964.4	94.5 EL.U/mL Interval 84.4 to 105.8

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of primary vaccination

Population: Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=334 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=325 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset	333 Subjects	141 Subjects

SECONDARY outcome

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST

Population: Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.

A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.

Outcome measures

Measure	Synflorix Group n=230 Participants Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=211 Participants Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. ANTI-PD, M1 POST BST (N=218;195)	218 Subjects	83 Subjects
Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. ANTI-PD, PRE (N=230;211)	223 Subjects	96 Subjects
Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. ANTI-PD, M9 POST-BST (N=206;182)	198 Subjects	84 Subjects

Adverse Events

Synflorix Group

Serious events: 2534 serious events

Other events: 3530 other events

Deaths: 19 deaths

Control Group

Serious events: 2668 serious events

Other events: 3518 other events

Deaths: 26 deaths

Serious adverse events

Measure	Synflorix Group n=3602 participants at risk；n=11798 participants at risk Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=3612 participants at risk；n=11799 participants at risk Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Blood and lymphatic system disorders Anaemia	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.08% 9/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Coagulopathy	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Febrile neutropenia	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Haemolysis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Haemolytic anaemia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Haemorrhagic disorder	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Hypersplenism	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Hypochromic anaemia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Iron deficiency anaemia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Leukaemoid reaction	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Lymphadenitis	0.10% 12/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.16% 19/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Lymphadenopathy	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Pancytopenia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Thrombocytopenia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Blood and lymphatic system disorders Neutropenia	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Cardiac disorders Cardiac failure	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Cardiac disorders Cardiac failure congestive	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Cardiac disorders Cardio-respiratory arrest	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Cardiac disorders Cyanosis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Cardiac disorders Intracardiac mass	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Cardiac disorders Ventricular arrhythmia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Cerebral palsy	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Coarctation of the aorta	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Congenital absence of bile ducts	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Congenital oral malformation	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Congenital syphilis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Cystic fibrosis	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Dermoid cyst	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Heart disease congenital	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Laryngomalacia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Meningomyelocele	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Porencephaly	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Pyloric stenosis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Retinoblastoma	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Sickle cell anaemia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Sickle cell anaemia with crisis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Spinal muscular atrophy	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Congenital, familial and genetic disorders Thalassaemia sickle cell	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Endocrine disorders Hyperadrenalism	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Endocrine disorders Hypothyroidism	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Eye disorders Conjunctivitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Eye disorders Conjunctivitis allergic	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Eye disorders Ulcerative keratitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Abdominal distension	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Abdominal mass	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Abdominal pain	0.07% 8/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Acute abdomen	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Appendix disorder	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Constipation	0.09% 11/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.08% 10/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Diarrhoea	0.53% 63/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.45% 53/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Dyspepsia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Enteritis	0.13% 15/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.17% 20/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Faecaloma	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Food poisoning	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Gastritis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Gastritis erosive	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Gingival bleeding	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Haematochezia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Ileus	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Ileus paralytic	0.28% 33/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.19% 23/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Infantile colic	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Inguinal hernia	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Inguinal hernia, obstructive	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Intestinal haemorrhage	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Intestinal obstruction	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Intestinal perforation	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Intussusception	0.12% 14/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.09% 11/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Malabsorption	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Mallory-weiss syndrome	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Stomatitis	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.05% 6/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Vomiting	0.36% 42/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.31% 37/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Crying	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Effusion	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Electrocution	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Hypothermia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Multi-organ failure	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Pyrexia	0.20% 24/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.26% 31/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Sudden death	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Sudden infant death syndrome	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Systemic inflammatory response syndrome	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Hepatobiliary disorders Cholangitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Hepatobiliary disorders Cholecystitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Hepatobiliary disorders Hepatic failure	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Hepatobiliary disorders Hepatitis acute	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Immune system disorders Drug hypersensitivity	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Immune system disorders Food allergy	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Immune system disorders Hypersensitivity	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.05% 6/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Immune system disorders Immunodeficiency	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Immune system disorders Milk allergy	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Immune system disorders Selective iga immunodeficiency	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Abdominal wall abscess	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Abscess	0.09% 11/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.08% 9/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Abscess limb	0.08% 10/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.14% 16/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Abscess neck	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.07% 8/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Abscess of eyelid	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Acarodermatitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Acquired immunodeficiency syndrome	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Acute sinusitis	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Adenoiditis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Adenovirus infection	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Amoebiasis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Amoebic dysentery	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Anal abscess	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Appendicitis	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Appendicitis perforated	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Arthritis bacterial	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Ascariasis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Atypical pneumonia	0.12% 14/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.10% 12/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bacteraemia	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.05% 6/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bacterial diarrhoea	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bacterial infection	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Breast abscess	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bronchiolitis	4.0% 473/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	4.4% 518/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bronchitis	1.1% 124/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	1.1% 129/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bronchopneumonia	0.90% 106/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.81% 95/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bullous impetigo	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Burn infection	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Cat scratch disease	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Cellulitis	0.38% 45/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.39% 46/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Cellulitis of male external genital organ	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Cellulitis orbital	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Colostomy infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Conjunctivitis bacterial	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Conjunctivitis chlamydial	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Conjunctivitis infective	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Croup infectious	0.08% 10/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.06% 7/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Cytomegalovirus hepatitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Dengue fever	0.15% 18/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.13% 15/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Diarrhoea infectious	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Dysentery	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Ear infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Empyema	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Encephalitis viral	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Enteritis infectious	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Enterococcal sepsis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Erysipelas	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Escherichia urinary tract infection	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Exanthema subitum	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations External ear cellulitis	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Fungal skin infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Gastroenteritis	4.7% 553/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	4.2% 497/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Gastroenteritis adenovirus	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Gastroenteritis bacterial	0.07% 8/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.08% 9/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Gastroenteritis rotavirus	0.32% 38/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.42% 49/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Gastroenteritis shigella	0.07% 8/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.07% 8/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Gastroenteritis viral	0.08% 9/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.08% 9/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Giardiasis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Gingivitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Hantaviral infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Herpangina	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Herpes simplex	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Herpes virus infection	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Impetigo	0.08% 10/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Infected bites	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Infected cyst	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Infected fistula	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Infectious mononucleosis	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Influenza	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Klebsiella bacteraemia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Klebsiella sepsis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Laryngitis	0.08% 9/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.12% 14/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Lobar pneumonia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Lung infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Lymph node abscess	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Mastoiditis	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Meningitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Meningitis aseptic	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Meningitis meningococcal	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Meningitis pneumococcal	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Meningitis viral	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Myiasis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Nasal abscess	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Nasopharyngitis	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Necrotising fasciitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Nosocomial infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Oral candidiasis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Oral herpes	0.09% 11/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Osteomyelitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Otitis externa	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Otitis media	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.07% 8/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Otitis media acute	0.14% 16/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.14% 16/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Paronychia	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Parotitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Periorbital cellulitis	0.10% 12/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.14% 16/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Peritonitis	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pertussis	0.16% 19/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.14% 16/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pharyngeal abscess	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pharyngitis	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.11% 13/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pharyngotonsillitis	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumococcal sepsis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumocystis jiroveci infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumonia	4.1% 478/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	4.7% 557/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumonia adenoviral	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumonia bacterial	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumonia influenzal	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumonia pneumococcal	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumonia respiratory syncytial viral	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumonia viral	0.07% 8/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.08% 9/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Postoperative wound infection	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pseudomembranous colitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pulmonary sepsis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pyelonephritis	0.09% 11/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.05% 6/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pyelonephritis acute	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pyoderma	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.07% 8/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pyomyositis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Respiratory syncytial virus bronchitis	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.05% 6/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Respiratory tract infection	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Respiratory tract infection viral	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Rhinitis	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.06% 7/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Roseola	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Salmonellosis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Scarlet fever	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Sepsis	0.09% 11/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.12% 14/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Sepsis syndrome	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Septic shock	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.06% 7/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Shigella infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Sinusitis	0.08% 9/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Skin candida	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Skin infection	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Staphylococcal bacteraemia	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Staphylococcal scalded skin syndrome	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Staphylococcal sepsis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Staphylococcal skin infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Streptococcal sepsis	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Subcutaneous abscess	0.07% 8/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.12% 14/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Systemic candida	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Thyroglossal cyst infection	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Tonsillitis	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Tooth abscess	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Tracheitis	0.07% 8/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.06% 7/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Typhoid fever	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Upper respiratory tract infection	0.13% 15/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.09% 11/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Urinary tract infection	0.64% 76/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.79% 93/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Urosepsis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Varicella	0.08% 10/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.15% 18/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Viral infection	0.10% 12/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.09% 11/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Viral pharyngitis	0.08% 9/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.06% 7/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Viral rash	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Viral sepsis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Viral tonsillitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Vulvovaginitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Wound infection	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Accidental exposure	0.08% 10/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.07% 8/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Accidental overdose	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Accidental poisoning	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Animal bite	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Arthropod bite	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Arthropod sting	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Back injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Burns first degree	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Burns second degree	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.07% 8/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Chemical injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Chemical poisoning	0.20% 24/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.18% 21/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Chest injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Contusion	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Craniocerebral injury	0.33% 39/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.31% 36/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Electric shock	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Electrical burn	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Eye burns	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Eye injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Eyelid injury	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Face injury	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Femur fracture	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Foreign body	0.14% 16/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.13% 15/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Fracture	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Gingival injury	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Hand fracture	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Head injury	0.64% 75/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.63% 74/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Herbal toxicity	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Humerus fracture	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Injury	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Laceration	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Mouth injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Multiple injuries	0.22% 26/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.28% 33/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Near drowning	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Open fracture	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Open wound	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Pneumonitis chemical	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Poisoning	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Skull fracture	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Thermal burn	0.21% 25/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.31% 36/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Tibia fracture	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Tongue injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Tooth fracture	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Toxicity to various agents	0.10% 12/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.10% 12/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Traumatic haematoma	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Upper limb fracture	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Vulvovaginal injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Wound	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Wound dehiscence	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Investigations Acid base balance abnormal	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Investigations Aspiration bronchial	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Cow's milk intolerance	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Dehydration	3.9% 463/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	3.7% 438/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Diabetes mellitus	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Electrolyte imbalance	0.07% 8/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Failure to thrive	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Feeding disorder neonatal	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Food intolerance	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Hypercalcaemia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Hypoglycaemia	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Hypokalaemia	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Malnutrition	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Metabolic acidosis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Connective tissue disorder	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Dactylitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Periostitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Synovitis	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Torticollis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Musculoskeletal and connective tissue disorders Trigger finger	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatoblastoma	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Histiocytosis haematophagic	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nephroblastoma	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroblastoma	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Retinoblastoma bilateral	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Ataxia	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Brain injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Brain oedema	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Cerebrospinal fistula	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Cns ventriculitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Convulsion	0.24% 28/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.21% 25/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Dystonia	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Encephalopathy	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Epilepsy	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Extrapyramidal disorder	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Febrile convulsion	0.81% 95/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	1.1% 135/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Grand mal convulsion	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Guillain-barre syndrome	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Infantile spasms	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Intracranial pressure increased	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Myoclonic epilepsy	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Post-traumatic epilepsy	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Presyncope	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Status epilepticus	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Syncope	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Nervous system disorders Viith nerve paralysis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Psychiatric disorders Agitation	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Psychiatric disorders Binge eating	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Psychiatric disorders Breath holding	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.05% 6/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Psychiatric disorders Psychomotor retardation	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Renal and urinary disorders Glomerulonephritis acute	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Renal and urinary disorders Haematuria	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Renal and urinary disorders Hydronephrosis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Renal and urinary disorders Nephrotic syndrome	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Renal and urinary disorders Oliguria	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Renal and urinary disorders Prerenal failure	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Renal and urinary disorders Pyelocaliectasis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Renal and urinary disorders Renal failure acute	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Reproductive system and breast disorders Balanoposthitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Reproductive system and breast disorders Genital lesion	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Acute lung injury	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Allergic bronchitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Apnoea	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Apnoeic attack	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Apparent life threatening event	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Asthma	0.70% 82/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.70% 83/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	1.6% 192/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	1.8% 210/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.08% 10/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.04% 5/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.14% 16/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.12% 14/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	1.1% 127/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	1.2% 141/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.08% 9/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Infantile asthma	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.05% 6/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.07% 8/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.03% 4/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.05% 6/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Wheezing	0.41% 48/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.36% 42/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Acute haemorrhagic oedema of infancy	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Angioedema	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Cutaneous loxoscelism	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis contact	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatosis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Haemorrhagic urticaria	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Heat rash	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Henoch-schonlein purpura	0.04% 5/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Rash	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Rash scarlatiniform	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Skin oedema	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Urticaria	0.08% 10/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.13% 15/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Social circumstances Alcohol use	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Social circumstances Physical abuse	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Surgical and medical procedures Finger amputation	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Surgical and medical procedures Therapeutic hypothermia	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Surgical and medical procedures Toe amputation	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Capillary fragility	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Extremity necrosis	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Flushing	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Haematoma	0.00% 0/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.02% 2/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Hypertension	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Hypovolaemic shock	0.03% 3/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Kawasaki's disease	0.08% 9/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 3/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Phlebitis	0.01% 1/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.01% 1/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Vascular disorders Shock	0.02% 2/11798 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.03% 4/11799 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.

Other adverse events

Measure	Synflorix Group n=3602 participants at risk；n=11798 participants at risk Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).	Control Group n=3612 participants at risk；n=11799 participants at risk Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Blood and lymphatic system disorders Anaemia	39.2% 1411/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	38.2% 1378/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Eye disorders Conjunctivitis	16.6% 598/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	15.9% 575/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Diarrhoea	52.9% 1905/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	49.7% 1794/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Vomiting	14.4% 520/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	14.0% 506/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Constipation	7.7% 279/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	7.1% 257/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Gastrointestinal disorders Stomatitis	4.8% 174/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.6% 202/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Injection site pain	10.7% 384/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.6% 201/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Pyrexia	63.1% 2272/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	53.0% 1916/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Irritability	38.2% 121/317 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	31.4% 95/303 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Injection site erythema	7.2% 260/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	4.8% 172/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Immune system disorders Hypersensitivity	8.7% 315/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	9.1% 328/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Nasopharyngitis	92.7% 3338/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	92.1% 3326/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Gastroenteritis	36.4% 1310/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	35.5% 1281/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bronchiolitis	31.1% 1119/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	31.1% 1123/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pharyngitis	26.4% 950/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	26.5% 958/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Viral infection	19.8% 714/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	20.4% 738/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pharyngotonsillitis	18.7% 672/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	18.9% 682/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Rhinitis	15.0% 542/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	14.3% 516/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Impetigo	13.8% 497/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	13.1% 474/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Bronchitis	13.5% 486/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	11.4% 410/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pyoderma	9.7% 350/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	10.2% 368/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Tonsillitis	6.4% 232/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	6.4% 232/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Pneumonia	6.0% 217/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	6.6% 238/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Urinary tract infection	5.6% 202/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	6.3% 228/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Infections and infestations Influenza	5.7% 206/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	4.8% 175/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Injury, poisoning and procedural complications Head injury	12.6% 454/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	11.2% 406/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Malnutrition	15.4% 556/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	15.1% 545/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Overweight	11.5% 416/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	11.7% 422/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Metabolism and nutrition disorders Dehydration	5.1% 182/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.7% 207/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Asthma	16.5% 596/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	16.1% 582/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Cough	13.9% 499/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	14.1% 510/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	8.0% 288/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	8.7% 313/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	8.9% 322/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	8.2% 297/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis	13.0% 468/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	12.8% 464/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis diaper	8.1% 293/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	8.7% 316/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis atopic	9.2% 332/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	8.2% 296/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Rash	6.1% 220/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	6.1% 220/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Prurigo	5.0% 179/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.5% 199/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Skin and subcutaneous tissue disorders Dermatitis allergic	4.5% 163/3602 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.4% 196/3612 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Pain	— 0/0 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	29.4% 89/303 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Redness	— 0/0 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	24.1% 73/303 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Swelling	— 0/0 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	18.2% 55/303 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Swelling†	21.8% 69/317 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	23.1% 70/303 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Drowsiness	23.3% 74/317 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	21.5% 65/303 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Fever (rectal temperature >= 38.0°C)	29.3% 93/317 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	24.1% 73/303 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Loss of appetite	16.1% 51/317 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	15.2% 46/303 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders PAIN	— 0/0 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	46.2% 165/357 • SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER