Trial Outcomes & Findings for A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates (NCT NCT04544787)

NCT ID: NCT04544787

Last Updated: 2021-10-15

Results Overview

An SAE is any untoward medical occurrence that at any dose met any of the following conditions: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing inpatient hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Was medically important. A solicited AE is a pre-selected sign or symptom that occurred within 7 days after each dose, whereas unsolicited AEs were collected throughout the study. Solicited AEs included headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea, abdominal pain, and fever. A severe AE is an AE that prevented normal everyday activities and which was not classified as an SAE. A related AE is an AE the investigator considered probably or possibly caused by the study vaccine, meaning that there was a reasonable temporal association or the AE was not attributable to other conditions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 250 participants
• Primary outcome timeframe: Up to 42 days after each vaccination
• Results posted on: 2021-10-15

Participant Flow

This study was conducted at 2 centers in Belgium. Two hundred and seventy-seven volunteers were screened between October 2018, and February 2019, and 250 participants were enrolled. Eligible participants were healthy adults aged 18-50 years with documented history of at least three polio vaccinations with either oral polio vaccine (OPV) or inactivated polio vaccine (IPV). Two novel oral polio type 2 vaccines (nOPV2) were tested: candidate 1 (nOPV2-c1) and candidate 2 (nOPV2-c2).

The novel OPV2-c2 candidate was prioritized so the first 100 OPV-vaccinated participants were randomly assigned 1:1 to Groups 3 and 4 to receive novel OPV2-c2. The second 100 OPV-vaccinated participants were randomly assigned 1:1 to Groups 1 and 2 to receive novel OPV2-c1. IPV-vaccinated adults were enrolled in parallel and randomly assigned 2:1 to Group 6 or Group 7 until Group 6 enrollment was complete, when 2:1 randomization was continued for Group 5 and Group 7.

Participant milestones

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 Participants previously vaccinated with OPV received one dose of novel oral polio vaccine type 2 (nOPV2) candidate 1 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ 50% cell culture infectious dose units \[CCID50\]).	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28), administered orally as six drops (0.3 mL total).
Overall Study STARTED	50	50	50	50	17	16	17
Overall Study Received First Dose of Vaccine	50	50	50	50	17	16	17
Overall Study Received Second Dose of Vaccine	0	49	0	49	17	15	16
Overall Study COMPLETED	50	50	50	50	17	16	17
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates

Baseline characteristics by cohort

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=50 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on study Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=50 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=50 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=50 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=17 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=16 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo n=17 Participants Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).	Total n=250 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 10 • n=5 Participants	31 years STANDARD_DEVIATION 10 • n=7 Participants	32 years STANDARD_DEVIATION 10 • n=5 Participants	34 years STANDARD_DEVIATION 10 • n=4 Participants	23 years STANDARD_DEVIATION 10 • n=21 Participants	31 years STANDARD_DEVIATION 9 • n=10 Participants	24 years STANDARD_DEVIATION 9 • n=115 Participants	29 years STANDARD_DEVIATION 10 • n=6 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	29 Participants n=7 Participants	28 Participants n=5 Participants	32 Participants n=4 Participants	11 Participants n=21 Participants	13 Participants n=10 Participants	14 Participants n=115 Participants	149 Participants n=6 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	18 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	101 Participants n=6 Participants
Race/Ethnicity, Customized White	49 Participants n=5 Participants	49 Participants n=7 Participants	49 Participants n=5 Participants	49 Participants n=4 Participants	16 Participants n=21 Participants	16 Participants n=10 Participants	15 Participants n=115 Participants	243 Participants n=6 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	5 Participants n=6 Participants
Number of Prior OPV Vaccinations None	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	17 Participants n=21 Participants	16 Participants n=10 Participants	17 Participants n=115 Participants	50 Participants n=6 Participants
Number of Prior OPV Vaccinations Three	49 Participants n=5 Participants	50 Participants n=7 Participants	41 Participants n=5 Participants	40 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	180 Participants n=6 Participants
Number of Prior OPV Vaccinations Four	1 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	19 Participants n=6 Participants
Number of Prior OPV Vaccinations Five	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Number of Prior IPV Vaccinations None	46 Participants n=5 Participants	49 Participants n=7 Participants	48 Participants n=5 Participants	47 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	190 Participants n=6 Participants
Number of Prior IPV Vaccinations One	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	10 Participants n=6 Participants
Number of Prior IPV Vaccinations Four	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=10 Participants	10 Participants n=115 Participants	20 Participants n=6 Participants
Number of Prior IPV Vaccinations Five	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants	5 Participants n=10 Participants	5 Participants n=115 Participants	20 Participants n=6 Participants
Number of Prior IPV Vaccinations Six or more	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=10 Participants	2 Participants n=115 Participants	10 Participants n=6 Participants

PRIMARY outcome

Timeframe: Up to 42 days after each vaccination

Population: The total vaccinated (TV) population includes all randomized participants who received at least one dose of study vaccine.

An SAE is any untoward medical occurrence that at any dose met any of the following conditions:

• Resulted in death;
• Was life-threatening;
• Required inpatient hospitalization or prolongation of existing inpatient hospitalization;
• Resulted in persistent or significant disability/incapacity;
• Was a congenital anomaly/birth defect;
• Was medically important.

A solicited AE is a pre-selected sign or symptom that occurred within 7 days after each dose, whereas unsolicited AEs were collected throughout the study. Solicited AEs included headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea, abdominal pain, and fever.

A severe AE is an AE that prevented normal everyday activities and which was not classified as an SAE.

A related AE is an AE the investigator considered probably or possibly caused by the study vaccine, meaning that there was a reasonable temporal association or the AE was not attributable to other conditions.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=50 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=50 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=50 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=50 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=17 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=16 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo n=17 Participants Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Serious adverse events related to study vaccine	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Serious or Severe adverse event	9 Participants	16 Participants	5 Participants	8 Participants	5 Participants	6 Participants	10 Participants
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Serious adverse events	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Severe adverse events	9 Participants	16 Participants	5 Participants	8 Participants	5 Participants	6 Participants	10 Participants
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Severe solicited adverse events	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Severe unsolicited adverse events	8 Participants	15 Participants	4 Participants	7 Participants	4 Participants	5 Participants	9 Participants
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Severe adverse events related to study vaccine	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants	5 Participants	4 Participants
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Serious solicited adverse events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events Serious unsolicited adverse events	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0 prior to vaccination) and Day 28

Population: Participants in the per-protocol population previously vaccinated with OPV. The per-protocol population excluded participants with missed doses or major protocol deviations considered to have a potential impact on immunogenicity from the time of the deviation and at all time points thereafter. This endpoint was analyzed after one dose of nOPV hence Groups 1 and 2 and Groups 3 and 4 are combined for analysis, as specified in the study protocol.

Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibody titers ≥ 1:8.

Neutralizing antibodies against poliovirus type 2 were determined using the World Health Organization (WHO) standard microneutralization assay (WHO EPI GEN 93.9). The lower limit of quantitation (LLOQ) was 5.7 and the upper limit of quantitation (ULOQ) was 1448.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=98 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=98 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients Day 0 (pre-vaccination)	99 percentage of participants Interval 94.0 to 100.0	94 percentage of participants Interval 87.0 to 98.0	—	—	—	—	—
Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients Day 28	100 percentage of participants Interval 96.0 to 100.0	100 percentage of participants Interval 96.0 to 100.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 7 days after each dose (Day 0-7 post-dose 1 and Day 28-35 post-dose 2)

Population: Participants in the total vaccinated population previously vaccinated with OPV.

Participants were asked to complete 7-day diary cards soliciting systemic adverse events and daily oral temperature. Solicited events comprised selected signs and symptoms including headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea and abdominal pain, or fever defined as a temperature of 37.5°C or higher.

AEs were graded as mild (easily tolerated with minimal discomfort or temperature 37.5°C to 38.0°C), moderate (sufficiently discomforting to interfere with normal everyday activities, or temperature 38.1°C to 39.0°C), or severe (preventing normal everyday activities, or temperatures higher than 39.0°C).

AEs were assessed by the investigator for causality. Probably related suggests that a reasonable temporal sequence of the AE with vaccine administration exists and, in the Investigator's clinical judgment, it is likely that a causal relationship exists between the vaccine administration and the AE,

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=100 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=49 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=100 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=49 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 Any solicited adverse event	71 Participants	26 Participants	74 Participants	21 Participants	—	—	—
Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 Mild	45 Participants	18 Participants	60 Participants	14 Participants	—	—	—
Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 Moderate	23 Participants	8 Participants	12 Participants	6 Participants	—	—	—
Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 Severe	3 Participants	0 Participants	2 Participants	1 Participants	—	—	—
Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 Probably related to vaccination	44 Participants	15 Participants	37 Participants	12 Participants	—	—	—

SECONDARY outcome

Timeframe: 7 days post-dose (Day 0-7 post-dose 1 and and Day 28-35 post-dose 2)

Population: Participants in the total vaccinated population previously vaccinated with IPV only.

Participants were asked to complete 7-day diary cards soliciting systemic adverse events and daily oral temperature. Solicited events comprised selected signs and symptoms including headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea and abdominal pain, or fever defined as a temperature of 37.5°C or higher.

AEs were graded as mild (easily tolerated with minimal discomfort or temperature 37.5°C to 38.0°C), moderate (sufficiently discomforting to interfere with normal everyday activities, or temperature 38.1°C to 39.0°C), or severe (preventing normal everyday activities, or temperatures higher than 39.0°C).

AEs were assessed by the investigator for causality. Probably related suggests that a reasonable temporal sequence of the AE with vaccine administration exists and, in the Investigator's clinical judgment, it is likely that a causal relationship exists between the vaccine administration and the AE,

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=17 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=17 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=16 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=15 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=17 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=16 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 Any solicited adverse events	16 Participants	11 Participants	13 Participants	9 Participants	15 Participants	12 Participants	—
Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 Mild	11 Participants	8 Participants	6 Participants	3 Participants	9 Participants	7 Participants	—
Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 Moderate	4 Participants	3 Participants	7 Participants	5 Participants	4 Participants	5 Participants	—
Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 Severe	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	—
Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 Probably related to vaccination	9 Participants	8 Participants	5 Participants	8 Participants	9 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Up to 42 days after each vaccination

Population: Total vaccinated population

Unsolicited events comprised other signs and symptoms that participants reported through the end of the study. Each unsolicited AE was rated on a 3-point scale of increasing intensity:

• Grade 1: Mild; an AE that was easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities.
• Grade 2: Moderate; an AE that was sufficiently discomforting to interfere with normal everyday activities.
• Grade 3: Severe; an AE that prevented normal everyday activities. Each adverse event was assessed by the investigator for causality as unrelated, unlikely, possibly, or probably related to the vaccination.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=50 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=50 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=50 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=50 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=17 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=16 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo n=17 Participants Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Number of Participants With Unsolicited Adverse Events Any unsolicited adverse event	34 Participants	43 Participants	38 Participants	42 Participants	15 Participants	13 Participants	17 Participants
Number of Participants With Unsolicited Adverse Events Mild	8 Participants	10 Participants	10 Participants	11 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Unsolicited Adverse Events Moderate	18 Participants	18 Participants	24 Participants	24 Participants	8 Participants	8 Participants	7 Participants
Number of Participants With Unsolicited Adverse Events Severe	8 Participants	15 Participants	4 Participants	7 Participants	4 Participants	5 Participants	9 Participants
Number of Participants With Unsolicited Adverse Events Probably related to vaccination	2 Participants	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 0, Day 7, Day 14, and Day 28 for Groups 1-4 and at Day 35, Day 42, and Day 56 for participants in Groups 2 and 4

Population: Participants in the total vaccinated population previously vaccinated with OPV.

Laboratory assessments were collected at one-week intervals from Day 0 to Day 28 (except for Day 21) and at Days 35, 42, and 56 for participants in Groups 2 and 4 who received a 2nd dose.

The Investigator reviewed laboratory values outside the normal range and assessed their clinical relevance.

Any clinically relevant abnormal lab values that occurred at any visit up to 28 days after the first vaccination (in combined Groups 1 and 2 and Groups 3 and 4) and up to 28 days (Day 56) after the second dose (Groups 2 and 4) are reported.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=100 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=50 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=100 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=50 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Number of Former OPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination	28 Participants	18 Participants	30 Participants	15 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 0, Day 7, Day 14, Day 28, Day 35, Day 42 and Day 56

Population: Participants in the total vaccinated population previously vaccinated with IPV only.

Laboratory assessments were collected at one-week intervals from Day 0 to Day 56, except for Days 21 and 49. The Investigator reviewed laboratory values outside the normal range and assessed their clinical relevance.

Any clinically relevant abnormal laboratory abnormalities that occurred at any visit up to 56 days are reported.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=17 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=16 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=17 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Number of Former IPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination	4 Participants	6 Participants	9 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28

Population: Per-protocol population. The per-protocol population excluded participants with missed doses or major protocol deviations considered to have a potential impact on immunogenicity from the time of the deviation and at all time points thereafter. This endpoint was analyzed after one dose of nOPV hence Groups 1 and 2 and Groups 3 and 4 are combined for analysis, as specified in the study protocol. Samples for 2 participants in Group 5 on Day 0 were mixed up and are not included in the analysis.

Neutralizing antibodies against poliovirus type 2 were determined using the World Health Organization (WHO) standard microneutralization assay (WHO EPI GEN 93.9). The lower limit of quantitation (LLOQ) was 5.7 and the upper limit of quantitation (ULOQ) was 1448. Data were calculated on log2-transformed type 2 neutralizing titers and back transformed for the presentation below. Values shown as 1448 should be interpreted as ≥ 1448.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=98 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=98 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=17 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=16 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=16 Participants Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 Day 0 (pre-vaccination)	324 titer Interval 228.0 to 455.0	455 titer Interval 256.0 to 724.0	228 titer Interval 74.0 to 588.0	144 titer Interval 26.0 to 446.0	91 titer Interval 11.0 to 362.0	—	—
Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 Day 28	1448 titer Interval 1448.0 to 1448.0	1152 titer Interval 815.0 to 1448.0	1448 titer Interval 1448.0 to 1448.0	1448 titer Interval 1176.0 to 1448.0	51 titer Interval 8.0 to 256.0	—	—

SECONDARY outcome

Timeframe: Day 56

Population: Participants in the per-protocol population previously vaccinated with OPV who received 2 doses of novel OPV2 (Groups 2 and 4).

Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibodies titers ≥ 1:8.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=49 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=49 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Seroprotection Rate 28 Days After Two Doses of Novel OPV2 in Former OPV Recipients	100 percentage of participants Interval 93.0 to 100.0	100 percentage of participants Interval 93.0 to 100.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0, Day 28, and Day 56

Population: Participants in the per-protocol population previously vaccinated with IPV only. Samples for 2 participants in Group 5 on Day 0 were mixed up and are not included in the analysis.

Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibodies titers ≥ 1:8.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=17 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=16 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=16 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Seroprotection Rate in Former IPV Recipients Day 0 (pre-vaccination)	93 percentage of participants Interval 68.0 to 100.0	94 percentage of participants Interval 70.0 to 100.0	81 percentage of participants Interval 54.0 to 96.0	—	—	—	—
Seroprotection Rate in Former IPV Recipients Day 28	100 percentage of participants Interval 80.0 to 100.0	100 percentage of participants Interval 79.0 to 100.0	75 percentage of participants Interval 48.0 to 93.0	—	—	—	—
Seroprotection Rate in Former IPV Recipients Day 56	100 percentage of participants Interval 80.0 to 100.0	100 percentage of participants Interval 78.0 to 100.0	81 percentage of participants Interval 54.0 to 96.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 28

Population: Participants in the seroconversion subset of the per-protocol population previously vaccinated with OPV. The seroconversion subset included participants with Baseline titer sufficiently low to enable observation of a four-fold increase without breaching the ULOQ (ie, a titer ≤ 362). Since this endpoint was analyzed after 1 dose of nOPV, Groups 1 and 2 and Groups 3 and 4 are combined for analysis.

Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, an antibody titer increase of ≥ 4-fold over Baseline titer.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=55 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=47 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Seroconversion Rate After a Single Dose of Novel OPV2 in Former OPV Recipients	74.5 percentage of participants Interval 61.0 to 85.3	51.1 percentage of participants Interval 36.1 to 65.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 56

Population: Participants in the seroconversion subset of the per-protocol population previously vaccinated with OPV and who received 2 doses of novel OPV2 (Groups 2 and 4). The seroconversion subset included participants with Baseline titer sufficiently low to enable observation of a four-fold increase without breaching the ULOQ (ie, a titer ≤ 362).

Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, an antibody titer increase of ≥ 4-fold over Baseline titer.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=27 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=26 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Seroconversion Rate After Two Doses of Novel OPV2 in Former OPV Recipients	74 percentage of participants Interval 54.0 to 89.0	58 percentage of participants Interval 37.0 to 77.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: Participants in the seroconversion subset of the per-protocol population previously vaccinated with IPV only. The seroconversion subset included participants with Baseline titer sufficiently low to enable observation of a four-fold increase without breaching the ULOQ (ie, a titer ≤ 362).

Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, a poliovirus type-2-specific neutralizing antibody titer increase of ≥ 4-fold over Baseline titer.

Outcome measures

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=10 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=12 Participants Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=12 Participants Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Seroconversion Rate in Former IPV Recipients Day 56	100 percentage of participants Interval 69.0 to 100.0	82 percentage of participants Interval 48.0 to 98.0	8 percentage of participants Interval 0.0 to 38.0	—	—	—	—
Seroconversion Rate in Former IPV Recipients Day 28	100 percentage of participants Interval 69.0 to 100.0	92 percentage of participants Interval 62.0 to 100.0	0 percentage of participants Interval 0.0 to 26.0	—	—	—	—

Adverse Events

Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Group 7: IPV-vaccinated - Two Doses of Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=50 participants at risk Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on study Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=50 participants at risk Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=50 participants at risk Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=50 participants at risk Participants previously vaccinated OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=17 participants at risk Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=16 participants at risk Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo n=17 participants at risk Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Gastrointestinal disorders Crohn's Disease	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Vomiting	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Immune system disorders Anaphylactic Reaction	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Influenza Like Illness	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).

Other adverse events

Measure	Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 n=50 participants at risk Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on study Day 0.	Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=50 participants at risk Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 n=50 participants at risk Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0.	Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=50 participants at risk Participants previously vaccinated OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 n=17 participants at risk Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28).	Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 n=16 participants at risk Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28).	Group 7: IPV-vaccinated - Two Doses of Placebo n=17 participants at risk Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28).
Investigations Gamma-Glutamyltransferase Increased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Lymphocyte Count Decreased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Upper Respiratory Tract Infection	18.0% 9/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	8.0% 4/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	14.0% 7/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	26.0% 13/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	31.2% 5/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	52.9% 9/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Nasopharyngitis	8.0% 4/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	8.0% 4/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	29.4% 5/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Gastroenteritis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Rhinitis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	12.5% 2/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Oral Herpes	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Sinusitis	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Influenza	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Acute Sinusitis	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Enterobiasis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Cystitis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Pharyngitis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Bronchitis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Conjunctivitis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Ear Infection	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Fungal Infection	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Furuncle	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Gastroenteritis Viral	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Herpes Simplex	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Infection	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Oral Candidiasis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Tinea Pedis	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Urinary Tract Infection	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Viral Rhinitis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Nervous system disorders Headache	22.0% 11/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	28.0% 14/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	32.0% 16/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	28.0% 14/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	35.3% 6/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	31.2% 5/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	41.2% 7/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Nervous system disorders Dizziness	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	25.0% 4/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Nervous system disorders Migraine	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Nervous system disorders Dysgeusia	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Nervous system disorders Paraesthesia	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Nervous system disorders Presyncope	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Nervous system disorders Sleep Deficit	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Diarrhoea	8.0% 4/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	12.0% 6/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	35.3% 6/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	18.8% 3/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	17.6% 3/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Abdominal Pain	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	8.0% 4/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	12.5% 2/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	23.5% 4/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Nausea	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	10.0% 5/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Constipation	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Toothache	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Dyspepsia	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	18.8% 3/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Flatulence	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	12.5% 2/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Gastrointestinal Sounds Abnormal	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Cheilitis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Dental Caries	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Hyperaesthesia Teeth	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Proctalgia	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Rectal Tenesmus	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Swollen Tongue	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Tongue Discomfort	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Vomiting	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	16.0% 8/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	14.0% 7/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	10.0% 5/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	17.6% 3/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	17.6% 3/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Nasal Congestion	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	17.6% 3/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Epistaxis	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Fatigue	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	18.8% 3/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	17.6% 3/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Influenza Like Illness	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	8.0% 4/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Pyrexia	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Asthenia	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Malaise	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Hangover	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Chest Pain	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Crepitations	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Feeling Cold	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Feeling Hot	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Back Pain	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Myalgia	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	12.5% 2/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	17.6% 3/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Neck Pain	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Blood Creatine Phosphokinase Increased	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	10.0% 5/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	8.0% 4/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	10.0% 5/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Alanine Aminotransferase Increased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Aspartate Aminotransferase Increased	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations C-Reactive Protein Increased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Neutrophil Count Increased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Blood Immunoglobulin A Decreased	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Blood Potassium Increased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Lymphocyte Percentage Decreased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Neutrophil Count Decreased	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Metabolism and nutrition disorders Hypophosphataemia	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	8.0% 4/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	10.0% 5/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	12.5% 2/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Metabolism and nutrition disorders Hypoglycaemia	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Acne	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Hyperhidrosis	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Rash	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Rash Generalised	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Reproductive system and breast disorders Dysmenorrhoea	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.0% 3/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Blood and lymphatic system disorders Leukopenia	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Injury, poisoning and procedural complications Animal Bite	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Injury, poisoning and procedural complications Procedural Nausea	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Vascular disorders Hypertension	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	4.0% 2/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Vascular disorders Haematoma	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Ear and labyrinth disorders Ear Pain	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Ear and labyrinth disorders Middle Ear Disorder	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Psychiatric disorders Burnout Syndrome	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Eye disorders Eye Irritation	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Cardiac disorders Palpitations	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Immune system disorders Seasonal Allergy	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Renal and urinary disorders Dysuria	2.0% 1/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Ear Lobe Infection	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Herpes Zoster	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Otitis Media	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Infections and infestations Rash Pustular	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Nervous system disorders Tension Headache	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Eructation	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Abnormal Faeces	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Gastrointestinal disorders Food Poisoning	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	12.5% 2/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Chills	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
General disorders Cyst	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Blood Bilirubin Increased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	11.8% 2/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Eosinophil Count Increased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Investigations Platelet Count Increased	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Skin and subcutaneous tissue disorders Swelling Face	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Cardiac disorders Angina Pectoris	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Injury, poisoning and procedural complications Contusion	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Injury, poisoning and procedural complications Head Injury	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	5.9% 1/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/50 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	6.2% 1/16 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).	0.00% 0/17 • Up to 42 days after each vaccination (42 days in Groups 1 and 3 and 70 days for all other Groups).

Additional Information

Pierre Van Damme, MD, PhD

University of Antwerp

Phone: +32 3 265 21 30

Email: pierre.vandamme@uantwerpen.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place