Trial Outcomes & Findings for Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects (NCT NCT00500266)

Last Updated: 2011-09-16

Results Overview

Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters\[cm\]); moderate(5.1-10.0 cm); severe(\>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1053 participants

Primary outcome timeframe

Days 1 through 14

Results posted on

2011-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	13vPnC Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Overall Study STARTED	1053
Overall Study Treated	1049
Overall Study COMPLETED	1040
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Overall Study Death	3
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	3
Overall Study Assigned, not treated	4

Baseline Characteristics

Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC n=1049 Participants Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Age Continuous	75.3 years STANDARD_DEVIATION 5.1 • n=93 Participants
Sex: Female, Male Female	584 Participants n=93 Participants
Sex: Female, Male Male	465 Participants n=93 Participants

PRIMARY outcome

Timeframe: Days 1 through 14

Population: Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting "yes" for at least 1 day or "no" for all days.

Outcome measures

Outcome measures
Measure	13vPnC n=1049 Participants Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Percentage of Participants With Pre-specified Local Reactions Redness: Any (n=666)	14.3 Percentage of Participants Interval 11.7 to 17.2
Percentage of Participants With Pre-specified Local Reactions Redness: Mild (n=660)	12.6 Percentage of Participants Interval 10.1 to 15.3
Percentage of Participants With Pre-specified Local Reactions Redness: Moderate (n=649)	6.5 Percentage of Participants Interval 4.7 to 8.6
Percentage of Participants With Pre-specified Local Reactions Redness: Severe (n=638)	1.1 Percentage of Participants Interval 0.4 to 2.2
Percentage of Participants With Pre-specified Local Reactions Swelling: Any (n=664)	12.8 Percentage of Participants Interval 10.4 to 15.6
Percentage of Participants With Pre-specified Local Reactions Swelling: Mild (n=658)	10.9 Percentage of Participants Interval 8.7 to 13.6
Percentage of Participants With Pre-specified Local Reactions Swelling: Moderate (n=651)	5.5 Percentage of Participants Interval 3.9 to 7.6
Percentage of Participants With Pre-specified Local Reactions Swelling: Severe (n=636)	0.6 Percentage of Participants Interval 0.2 to 1.6
Percentage of Participants With Pre-specified Local Reactions Pain: Any (n=777)	51.0 Percentage of Participants Interval 47.4 to 54.5
Percentage of Participants With Pre-specified Local Reactions Pain: Mild (n=770)	49.4 Percentage of Participants Interval 45.8 to 52.9
Percentage of Participants With Pre-specified Local Reactions Pain: Moderate (n=656)	9.0 Percentage of Participants Interval 6.9 to 11.4
Percentage of Participants With Pre-specified Local Reactions Pain: Severe (n=634)	0.2 Percentage of Participants Interval 0.0 to 0.9
Percentage of Participants With Pre-specified Local Reactions Limitation of arm movement: Any (n=679)	16.2 Percentage of Participants Interval 13.5 to 19.2
Percentage of Participants With Pre-specified Local Reactions Limitation of arm movement: Mild (n=674)	14.8 Percentage of Participants Interval 12.2 to 17.7
Percentage of Participants With Pre-specified Local Reactions Limitation of arm movement: Moderate (n=636)	1.6 Percentage of Participants Interval 0.8 to 2.9
Percentage of Participants With Pre-specified Local Reactions Limitation of arm movement: Severe (n=640)	1.6 Percentage of Participants Interval 0.8 to 2.9
Percentage of Participants With Pre-specified Local Reactions Any local reaction (n=802)	56.6 Percentage of Participants Interval 53.1 to 60.1
Percentage of Participants With Pre-specified Local Reactions Any severe local reaction (n=643)	2.6 Percentage of Participants Interval 1.5 to 4.2

PRIMARY outcome

Timeframe: Days 1 through 14

Population: Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as "yes" for at least 1 day or as "no" for all days.

Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(\>=38 degrees Celsius\[C\]), chills, rash, vomiting(mild:1-2 times daily; moderate:\>2 times daily; severe:prevents daily activity) decreased appetite \& diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:\>=6 loose stools/day) reported. Participants may be represented in \>1 category.

Outcome measures

Outcome measures
Measure	13vPnC n=1049 Participants Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Percentage of Participants With Pre-specified Systemic Events Fever (any): >=38 degrees C (n=641)	2.0 Percentage of Participants Interval 1.1 to 3.4
Percentage of Participants With Pre-specified Systemic Events Fever: >=38 degrees C but <38.5 degrees C (n=636)	0.8 Percentage of Participants Interval 0.3 to 1.8
Percentage of Participants With Pre-specified Systemic Events Fever: >=38.5 degrees C but <39 degrees C (n=634)	0.0 Percentage of Participants Interval 0.0 to 0.6
Percentage of Participants With Pre-specified Systemic Events Fever: >=39 degrees C but <=40 degrees C (n=635)	0.3 Percentage of Participants Interval 0.0 to 1.1
Percentage of Participants With Pre-specified Systemic Events Fever: >40 degrees C (n=638)	0.9 Percentage of Participants Interval 0.3 to 2.0
Percentage of Participants With Pre-specified Systemic Events Fatigue: Any (n=733)	34.4 Percentage of Participants Interval 30.9 to 37.9
Percentage of Participants With Pre-specified Systemic Events Fatigue: Mild (n=710)	28.7 Percentage of Participants Interval 25.4 to 32.2
Percentage of Participants With Pre-specified Systemic Events Fatigue: Moderate (n=683)	15.2 Percentage of Participants Interval 12.6 to 18.1
Percentage of Participants With Pre-specified Systemic Events Fatigue: Severe (n=639)	2.0 Percentage of Participants Interval 1.1 to 3.5
Percentage of Participants With Pre-specified Systemic Events Headache: Any (n=702)	26.1 Percentage of Participants Interval 22.9 to 29.5
Percentage of Participants With Pre-specified Systemic Events Headache: Mild (n=696)	24.1 Percentage of Participants Interval 21.0 to 27.5
Percentage of Participants With Pre-specified Systemic Events Headache: Moderate (n=655)	9.0 Percentage of Participants Interval 6.9 to 11.5
Percentage of Participants With Pre-specified Systemic Events Headache: Severe (n=637)	0.8 Percentage of Participants Interval 0.3 to 1.8
Percentage of Participants With Pre-specified Systemic Events Chills (n=651)	7.5 Percentage of Participants Interval 5.6 to 9.8
Percentage of Participants With Pre-specified Systemic Events Rash (n=658)	8.4 Percentage of Participants Interval 6.4 to 10.7
Percentage of Participants With Pre-specified Systemic Events Vomiting: Any (vomiting present; n=638)	0.9 Percentage of Participants Interval 0.3 to 2.0
Percentage of Participants With Pre-specified Systemic Events Vomiting: Mild (1 to 2 times in 24 hours;n=637)	0.8 Percentage of Participants Interval 0.3 to 1.8
Percentage of Participants With Pre-specified Systemic Events Vomiting: Moderate (>2 times in 24 hours;n=635)	0.2 Percentage of Participants Interval 0.0 to 0.9
Percentage of Participants With Pre-specified Systemic Events Vomiting: Severe (prevents routine activity;n=634)	0.0 Percentage of Participants Interval 0.0 to 0.6
Percentage of Participants With Pre-specified Systemic Events Decreased appetite (n=668)	11.2 Percentage of Participants Interval 8.9 to 13.9
Percentage of Participants With Pre-specified Systemic Events Diarrhea: Any (diarrhea present; n=684)	14.5 Percentage of Participants Interval 11.9 to 17.3
Percentage of Participants With Pre-specified Systemic Events Diarrhea: Mild (2 to 3 loose stools/day; n=678)	12.8 Percentage of Participants Interval 10.4 to 15.6
Percentage of Participants With Pre-specified Systemic Events Diarrhea: Moderate (4 to 5 loose stools/day;n=644)	3.4 Percentage of Participants Interval 2.2 to 5.1
Percentage of Participants With Pre-specified Systemic Events Diarrhea: Severe (>=6 loose stools/day; n=635)	0.3 Percentage of Participants Interval 0.0 to 1.1
Percentage of Participants With Pre-specified Systemic Events New generalized muscle pain: Any (n=700)	25.3 Percentage of Participants Interval 22.1 to 28.7
Percentage of Participants With Pre-specified Systemic Events New generalized muscle pain: Mild (n=679)	20.5 Percentage of Participants Interval 17.5 to 23.7
Percentage of Participants With Pre-specified Systemic Events New generalized muscle pain: Moderate (n=658)	7.9 Percentage of Participants Interval 6.0 to 10.2
Percentage of Participants With Pre-specified Systemic Events New generalized muscle pain: Severe (n=636)	0.6 Percentage of Participants Interval 0.2 to 1.6
Percentage of Participants With Pre-specified Systemic Events Aggravated generalized muscle pain: Any (n=669)	12.3 Percentage of Participants Interval 9.9 to 15.0
Percentage of Participants With Pre-specified Systemic Events Aggravated generalized muscle pain: Mild (n=650)	7.5 Percentage of Participants Interval 5.6 to 9.8
Percentage of Participants With Pre-specified Systemic Events Aggravated generalized muscle pain:Moderate(n=655)	6.4 Percentage of Participants Interval 4.7 to 8.6
Percentage of Participants With Pre-specified Systemic Events Aggravated generalized muscle pain: Severe (n=639)	1.4 Percentage of Participants Interval 0.6 to 2.7
Percentage of Participants With Pre-specified Systemic Events New generalized joint pain: Any (n=665)	12.8 Percentage of Participants Interval 10.3 to 15.6
Percentage of Participants With Pre-specified Systemic Events New generalized joint pain: Mild (n=651)	8.1 Percentage of Participants Interval 6.2 to 10.5
Percentage of Participants With Pre-specified Systemic Events New generalized joint pain: Moderate (n=648)	5.7 Percentage of Participants Interval 4.1 to 7.8
Percentage of Participants With Pre-specified Systemic Events New generalized joint pain: Severe (n=637)	0.8 Percentage of Participants Interval 0.3 to 1.8
Percentage of Participants With Pre-specified Systemic Events Aggravated generalized joint pain: Any (n=661)	9.7 Percentage of Participants Interval 7.5 to 12.2
Percentage of Participants With Pre-specified Systemic Events Aggravated generalized joint pain: Mild (n=647)	5.7 Percentage of Participants Interval 4.1 to 7.8
Percentage of Participants With Pre-specified Systemic Events Aggravated generalized joint pain: Moderate(n=647)	5.1 Percentage of Participants Interval 3.5 to 7.1
Percentage of Participants With Pre-specified Systemic Events Aggravated generalized joint pain: Severe (n=637)	1.1 Percentage of Participants Interval 0.4 to 2.3
Percentage of Participants With Pre-specified Systemic Events Any systemic event (n=832)	58.4 Percentage of Participants Interval 55.0 to 61.8

PRIMARY outcome

Timeframe: Days 1 through 14

Population: Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as "yes" for at least 1 day or as "no" for all days.

Use of pain or antipyretic medication was collected by the participants using an electronic diary.

Outcome measures

Outcome measures
Measure	13vPnC n=1049 Participants Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Percentage of Participants Taking Pain or Antipyretic Medication Use of medication to treat pain (n=677)	17.0 Percentage of Participants Interval 14.2 to 20.0
Percentage of Participants Taking Pain or Antipyretic Medication Use of medication to treat fever (n=655)	6.4 Percentage of Participants Interval 4.7 to 8.6

Adverse Events

13vPnC: Visit 1 to Visit 2

Serious events: 10 serious events

Other events: 486 other events

Deaths: 0 deaths

13vPnC: 6-month Follow-up

Serious events: 41 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	13vPnC: Visit 1 to Visit 2 n=1049 participants at risk Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.	13vPnC: 6-month Follow-up n=1049 participants at risk Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.
Cardiac disorders Bradyarrhythmia	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Tachyarrhythmia	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Gastrointestinal disorders Gastritis	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Gastrointestinal disorders Small intestinal obstruction	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Appendicitis	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Injury, poisoning and procedural complications Hip fracture	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.19% 2/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Nervous system disorders Loss of consciousness	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Skin burning sensation	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Vascular disorders Peripheral arterial occlusive disease	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Myocardial infarction	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.29% 3/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Atrial fibrillation	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.19% 2/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Acute coronary syndrome	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Cardiac arrest	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Cardiac failure	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Cardiac failure congestive	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Coronary artery disease	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Pneumonia	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.29% 3/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Abscess limb	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Bacteraemia	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Bronchitis	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Cellulitis	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Enteritis infectious	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Lower respiratory tract infection	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Infections and infestations Septic shock	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Injury, poisoning and procedural complications Fall	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Injury, poisoning and procedural complications Postoperative renal failure	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.19% 2/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.00% 0/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	0.10% 1/1049 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.

Other adverse events
Measure	13vPnC: Visit 1 to Visit 2 n=1049 participants at risk Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.	13vPnC: 6-month Follow-up n=1049 participants at risk Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.
Skin and subcutaneous tissue disorders Redness (any)	14.3% 95/666 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Redness (mild)	12.6% 83/660 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Redness (moderate)	6.5% 42/649 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Redness (severe)	1.1% 7/638 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Swelling (any)	12.8% 85/664 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Swelling (mild)	10.9% 72/658 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Swelling (moderate)	5.5% 36/651 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Swelling (severe)	0.63% 4/636 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Pain (any)	51.0% 396/777 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Pain (mild)	49.4% 380/770 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Pain (moderate)	9.0% 59/656 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Pain (severe)	0.16% 1/634 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Limitation of arm movement (any)	16.2% 110/679 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Limitation of arm movement (mild)	14.8% 100/674 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Limitation of arm movement (moderate)	1.6% 10/636 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
Skin and subcutaneous tissue disorders Limitation of arm movement (severe)	1.6% 10/640 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fever (any)	2.0% 13/641 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fever (mild)	0.79% 5/636 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fever (moderate)	0.00% 0/634 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fever (severe)	0.31% 2/635 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fever (potentially life threatening)	0.94% 6/638 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fatigue (any)	34.4% 252/733 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fatigue (mild)	28.7% 204/710 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fatigue (moderate)	15.2% 104/683 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Fatigue (severe)	2.0% 13/639 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Headache (any)	26.1% 183/702 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Headache (mild)	24.1% 168/696 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Headache (moderate)	9.0% 59/655 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Headache (severe)	0.78% 5/637 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Chills	7.5% 49/651 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Rash	8.4% 55/658 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Vomiting (any)	0.94% 6/638 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Vomiting (mild)	0.78% 5/637 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Vomiting (moderate)	0.16% 1/635 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Vomiting (severe)	0.00% 0/634 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Decreased appetite	11.2% 75/668 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Diarrhea (any)	14.5% 99/684 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Diarrhea (mild)	12.8% 87/678 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Diarrhea (moderate)	3.4% 22/644 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
General disorders Diarrhea (severe)	0.31% 2/635 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.	— 0/0 • Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3. Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.