Trial Outcomes & Findings for Safety and Immunogenicity Study of Trivalent P2-VP8 Subunit Rotavirus Vaccine in Adults, Toddlers and Infants (NCT NCT02646891)

Last Updated: 2020-03-10

Results Overview

Any symptom starting after 7 days post any study injection was recorded as an adverse event. A serious adverse event (SAE) is any event that occurred from the first dose of study drug that resulted in any of the following outcomes: 1. Death 2. Life-threatening AE 3. Inpatient hospitalization or prolongation of existing hospitalization 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. Congenital abnormality or birth defect 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the outcomes listed above. The severity of adverse events was graded from Mild (grade 1) to Life Threatening (grade 4). AEs related to study drug were those events for which there was a reasonable possibility that the study drug caused the event In the opinion of the site investigator.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

618 participants

Primary outcome timeframe

Up to 28 days after any vaccination (up to Day 28 for toddlers and up to Day 84 for infants and adults)

Results posted on

2020-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Adult: Placebo Adult participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.	Adult: P2-VP8 (30 µg) Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.	Adult: P2-VP8 (90 µg) Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.	Toddler: Placebo Toddler participants who received one intramuscular injection of placebo on day 0. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.	Toddler: P2-VP8 (30 µg) Toddler participants who received one intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) on day 0.	Toddler: P2-VP8 (90 µg) Toddler participants who received one intramuscular injection of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) on day 0.	Infant: Placebo Infant participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately one third of the participants were compared to the arm receiving the 15 µg dose of P2-VP8; once the safety of the 15 µg dose was established, one third of the participants were compared to the arm receiving 30 µg; and the last third were compared to the arm receiving 90 µg after the safety of the 30 µg dose was established.	Infant: P2-VP8 (15 µg) Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (15 µg) four weeks apart on days 0, 28, and 56.	Infant: P2-VP8 (30 µg) Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.	Infant: P2-VP8 (90 µg) Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.
Overall Study STARTED	6	12	12	6	12	12	139	140	140	139
Overall Study Received at Least 1 Dose	6	12	12	6	12	12	139	139	140	139
Overall Study COMPLETED	4	11	11	6	12	12	130	127	130	134
Overall Study NOT COMPLETED	2	1	1	0	0	0	9	13	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Adult: Placebo Adult participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.	Adult: P2-VP8 (30 µg) Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.	Adult: P2-VP8 (90 µg) Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.	Infant: Placebo Infant participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately one third of the participants were compared to the arm receiving the 15 µg dose of P2-VP8; once the safety of the 15 µg dose was established, one third of the participants were compared to the arm receiving 30 µg; and the last third were compared to the arm receiving 90 µg after the safety of the 30 µg dose was established.	Infant: P2-VP8 (15 µg) Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (15 µg) four weeks apart on days 0, 28, and 56.	Infant: P2-VP8 (30 µg) Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.	Infant: P2-VP8 (90 µg) Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.
Overall Study Adverse Event	0	1	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	0	2	2	2	2
Overall Study Protocol Violation	0	0	0	1	1	0	0
Overall Study Withdrawal by Subject	2	0	1	5	9	7	3
Overall Study Death	0	0	0	1	1	1	0

Baseline Characteristics

Height was not collected for one participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults: Placebo n=6 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo n=139 Participants Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 n=140 Participants Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 n=140 Participants Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 n=139 Participants Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Total n=618 Participants Total of all reporting groups
Age, Continuous	25.3 years STANDARD_DEVIATION 2.1 • n=6 Participants	32.0 years STANDARD_DEVIATION 4.8 • n=12 Participants	26.0 years STANDARD_DEVIATION 6.0 • n=12 Participants	2.6 years STANDARD_DEVIATION 0.1 • n=6 Participants	2.6 years STANDARD_DEVIATION 0.2 • n=12 Participants	2.5 years STANDARD_DEVIATION 0.2 • n=12 Participants	0.13 years STANDARD_DEVIATION 0.01 • n=139 Participants	0.13 years STANDARD_DEVIATION 0.01 • n=140 Participants	0.13 years STANDARD_DEVIATION 0.01 • n=140 Participants	0.13 years STANDARD_DEVIATION 0.01 • n=139 Participants	16.3 years STANDARD_DEVIATION 2.6 • n=618 Participants
Sex: Female, Male Female	3 Participants n=6 Participants	6 Participants n=12 Participants	9 Participants n=12 Participants	4 Participants n=6 Participants	7 Participants n=12 Participants	5 Participants n=12 Participants	67 Participants n=139 Participants	66 Participants n=140 Participants	76 Participants n=140 Participants	64 Participants n=139 Participants	307 Participants n=618 Participants
Sex: Female, Male Male	3 Participants n=6 Participants	6 Participants n=12 Participants	3 Participants n=12 Participants	2 Participants n=6 Participants	5 Participants n=12 Participants	7 Participants n=12 Participants	72 Participants n=139 Participants	74 Participants n=140 Participants	64 Participants n=140 Participants	75 Participants n=139 Participants	311 Participants n=618 Participants
Race/Ethnicity, Customized Black	6 Participants n=6 Participants	12 Participants n=12 Participants	12 Participants n=12 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants	12 Participants n=12 Participants	137 Participants n=139 Participants	138 Participants n=140 Participants	138 Participants n=140 Participants	136 Participants n=139 Participants	609 Participants n=618 Participants
Race/Ethnicity, Customized White	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=139 Participants	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=139 Participants	0 Participants n=618 Participants
Race/Ethnicity, Customized Indian	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=139 Participants	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=139 Participants	0 Participants n=618 Participants
Race/Ethnicity, Customized Colored	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	2 Participants n=139 Participants	2 Participants n=140 Participants	1 Participants n=140 Participants	3 Participants n=139 Participants	8 Participants n=618 Participants
Race/Ethnicity, Customized Unspecified	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=139 Participants	0 Participants n=140 Participants	1 Participants n=140 Participants	0 Participants n=139 Participants	1 Participants n=618 Participants
Height	167.0 centimeters STANDARD_DEVIATION 12.5 • n=6 Participants • Height was not collected for one participant.	164.4 centimeters STANDARD_DEVIATION 10.6 • n=12 Participants • Height was not collected for one participant.	160.6 centimeters STANDARD_DEVIATION 8.3 • n=12 Participants • Height was not collected for one participant.	88.8 centimeters STANDARD_DEVIATION 6.8 • n=6 Participants • Height was not collected for one participant.	86.4 centimeters STANDARD_DEVIATION 7.6 • n=12 Participants • Height was not collected for one participant.	88.5 centimeters STANDARD_DEVIATION 4.3 • n=12 Participants • Height was not collected for one participant.	55.4 centimeters STANDARD_DEVIATION 2.35 • n=138 Participants • Height was not collected for one participant.	54.9 centimeters STANDARD_DEVIATION 2.48 • n=140 Participants • Height was not collected for one participant.	55.1 centimeters STANDARD_DEVIATION 2.24 • n=140 Participants • Height was not collected for one participant.	55.3 centimeters STANDARD_DEVIATION 1.98 • n=139 Participants • Height was not collected for one participant.	62.0 centimeters STANDARD_DEVIATION 24.2 • n=617 Participants • Height was not collected for one participant.
Weight	62.7 kilograms STANDARD_DEVIATION 8.1 • n=6 Participants • Weight for one participant was missing.	68.7 kilograms STANDARD_DEVIATION 10.4 • n=12 Participants • Weight for one participant was missing.	61.2 kilograms STANDARD_DEVIATION 10.2 • n=11 Participants • Weight for one participant was missing.	13.8 kilograms STANDARD_DEVIATION 2.4 • n=6 Participants • Weight for one participant was missing.	12.6 kilograms STANDARD_DEVIATION 1.5 • n=12 Participants • Weight for one participant was missing.	13.5 kilograms STANDARD_DEVIATION 2.3 • n=12 Participants • Weight for one participant was missing.	4.9 kilograms STANDARD_DEVIATION 0.59 • n=139 Participants • Weight for one participant was missing.	4.8 kilograms STANDARD_DEVIATION 0.66 • n=140 Participants • Weight for one participant was missing.	4.8 kilograms STANDARD_DEVIATION 0.54 • n=140 Participants • Weight for one participant was missing.	4.9 kilograms STANDARD_DEVIATION 0.58 • n=139 Participants • Weight for one participant was missing.	8.1 kilograms STANDARD_DEVIATION 13.0 • n=617 Participants • Weight for one participant was missing.

PRIMARY outcome

Timeframe: Up to 28 days after any vaccination (up to Day 28 for toddlers and up to Day 84 for infants and adults)

Population: Safety population included all participants who were randomized and received at least one injection of the study drug.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=6 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo n=139 Participants Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 n=139 Participants Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 n=140 Participants Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 n=139 Participants Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination Any grade 2 or higher AE related to study drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination Any AE	2 Participants	8 Participants	9 Participants	3 Participants	8 Participants	6 Participants	119 Participants	118 Participants	122 Participants	124 Participants
Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination Any grade 2 or higher AE	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	19 Participants	24 Participants	18 Participants	20 Participants
Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination Any AE related to study drug	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination Any serious adverse event	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants	8 Participants	4 Participants	4 Participants

PRIMARY outcome

Timeframe: 7 days following each vaccination

Population: Safety population

Reactogenicity data (solicited signs or symptoms) were assessed for 7 days after each injection. Participants and parents were instructed to assess and record daily local reactions (injection site pain/tenderness, redness, swelling, itching), as well as systemic signs and symptoms (fever, headache, vomiting, nausea, fatigue, chills and myalgia for adults; and fever, vomiting, decreased appetite, irritability, and decreased activity for toddlers and infants) in a participant memory aid. Reactions were graded on a scale from mild (Grade 1) to life-threatening (Grade 4). The overall number of participants who experienced any local or systemic reaction is reported. Grades are based on maximum severity per participant.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=6 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo n=139 Participants Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 n=139 Participants Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 n=140 Participants Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 n=139 Participants Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Any local reaction	1 Participants	7 Participants	9 Participants	2 Participants	6 Participants	2 Participants	93 Participants	102 Participants	109 Participants	108 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Local reaction: Grade 1	1 Participants	6 Participants	6 Participants	2 Participants	4 Participants	2 Participants	84 Participants	83 Participants	96 Participants	92 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Local reaction: Grade 2	0 Participants	1 Participants	3 Participants	0 Participants	2 Participants	0 Participants	9 Participants	19 Participants	13 Participants	16 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Local reaction: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Local reaction: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Any systemic reaction	5 Participants	6 Participants	9 Participants	4 Participants	5 Participants	2 Participants	116 Participants	114 Participants	113 Participants	115 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Systemic reaction: Grade 1	5 Participants	6 Participants	6 Participants	3 Participants	5 Participants	2 Participants	86 Participants	70 Participants	83 Participants	73 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Systemic reaction : Grade 2	0 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	30 Participants	39 Participants	28 Participants	40 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Systemic reaction: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	2 Participants	2 Participants
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination Systemic reaction: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 84

Population: Per-protocol population included all randomized participants who adhered to the protocol, completed all their scheduled visits and vaccinations up to the analysis time point and presented no major protocol violations (defined as a protocol violation that was considered to have an impact on the immunogenicity results of the study).

Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the third injection (Day 84). Measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for decay in maternal IgG antibodies. The estimated maternal antibody half-life was derived from linear regression of Log2 transformed titers in placebo recipients from the combined infant cohorts.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=130 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=132 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=132 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=134 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen P[6]	38 Participants	131 Participants	132 Participants	134 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen P[8]	13 Participants	131 Participants	130 Participants	134 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen Any 2 antigens	16 Participants	131 Participants	130 Participants	134 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen All 3 antigens	11 Participants	131 Participants	130 Participants	134 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen P[4]	16 Participants	131 Participants	130 Participants	134 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 84

Population: Per-protocol population participants with available data

Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the final injection (Day 84). Measured by enzyme-linked immunosorbent assay (ELISA) to whole viral lysate.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=130 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=131 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=132 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=134 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen P[4]	13 Participants	35 Participants	40 Participants	32 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen P[6]	13 Participants	37 Participants	44 Participants	34 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen P[8]	11 Participants	36 Participants	26 Participants	28 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen Any 2 antigens	11 Participants	34 Participants	35 Participants	29 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen All 3 antigens	7 Participants	19 Participants	16 Participants	16 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 84

Population: Per-protocol population participants with available data for each strain

Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the final injection (Day 84). Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured using a validated assay. For infants, antibody titer was adjusted for decay in maternal antibodies.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=130 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=132 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=132 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=134 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain Rotavirus strain Wa	26 Participants	96 Participants	107 Participants	105 Participants	—	—	—	—	—	—
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain Rotavirus strain DS-1	26 Participants	100 Participants	105 Participants	108 Participants	—	—	—	—	—	—
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain Rotavirus strain 1076	16 Participants	90 Participants	103 Participants	109 Participants	—	—	—	—	—	—
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain Any 2 strains	15 Participants	101 Participants	108 Participants	114 Participants	—	—	—	—	—	—
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain All 3 strains	10 Participants	65 Participants	81 Participants	83 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and Days 56 (pre-vaccination) and 84

Population: Per-protocol population; participants with valid specimens at each time point.

Measured by ELISA at Baseline, 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and 28 days after the third and final injection (Day 84; primary outcome).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=135 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=137 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=132 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=137 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[4]: Day 84	28 titer Interval 22.0 to 36.0	3888 titer Interval 3313.0 to 4562.0	4205 titer Interval 3692.0 to 4789.0	5244 titer Interval 4729.0 to 5815.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[6]: Baseline	67 titer Interval 52.0 to 86.0	73 titer Interval 58.0 to 92.0	63 titer Interval 49.0 to 82.0	66 titer Interval 52.0 to 83.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[6]: Day 84	50 titer Interval 39.0 to 64.0	14028 titer Interval 11980.0 to 16426.0	14724 titer Interval 13181.0 to 16447.0	17085 titer Interval 15295.0 to 19085.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[8]: Day 84	30 titer Interval 23.0 to 39.0	5365 titer Interval 4454.0 to 6321.0	5792 titer Interval 5086.0 to 6595.0	7088 titer Interval 6314.0 to 7958.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[4]: Baseline	73 titer Interval 57.0 to 94.0	80 titer Interval 64.0 to 101.0	62 titer Interval 48.0 to 79.0	76 titer Interval 62.0 to 94.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[4]: Day 56	30 titer Interval 24.0 to 38.0	1456 titer Interval 1244.0 to 1705.0	1849 titer Interval 1581.0 to 2163.0	2424 titer Interval 2099.0 to 2800.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[6]: Day 56	47 titer Interval 38.0 to 58.0	5031 titer Interval 4305.0 to 5880.0	5709 titer Interval 4932.0 to 6609.0	7122 titer Interval 6176.0 to 8213.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[8]: Baseline	84 titer Interval 66.0 to 109.0	86 titer Interval 69.0 to 109.0	74 titer Interval 59.0 to 94.0	81 titer Interval 65.0 to 100.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen P[8]: Day 56	35 titer Interval 28.0 to 45.0	1897 titer Interval 1616.0 to 2227.0	2323 titer Interval 1985.0 to 2719.0	3050 titer Interval 2621.0 to 3549.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and Days 56 (pre-vaccination) and 84

Population: Per-protocol population; participants with valid specimens at each time point.

Measured by ELISA at Baseline, 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and 28 days after the third and final injection (Day 84; primary outcome).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=135 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=137 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=132 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=137 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[4]: Baseline	5 titer Interval 5.0 to 5.0	5 titer Interval 5.0 to 6.0	5 titer Interval 5.0 to 5.0	5 titer Interval 5.0 to 5.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[4]: Day 84	7 titer Interval 5.0 to 8.0	13 titer Interval 10.0 to 17.0	12 titer Interval 10.0 to 15.0	10 titer Interval 9.0 to 12.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[6]: Baseline	5 titer Interval 4.0 to 5.0	5 titer Interval 5.0 to 6.0	5 titer Interval 4.0 to 5.0	5 titer Interval 5.0 to 6.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[6]: Day 56	6 titer Interval 6.0 to 7.0	9 titer Interval 7.0 to 10.0	10 titer Interval 8.0 to 12.0	10 titer Interval 8.0 to 12.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[8]: Day 84	6 titer Interval 5.0 to 7.0	11 titer Interval 9.0 to 13.0	9 titer Interval 8.0 to 11.0	8 titer Interval 7.0 to 10.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[4]: Day 56	6 titer Interval 5.0 to 7.0	9 titer Interval 7.0 to 11.0	10 titer Interval 8.0 to 12.0	9 titer Interval 7.0 to 10.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[6]: Day 84	7 titer Interval 6.0 to 8.0	12 titer Interval 10.0 to 15.0	13 titer Interval 10.0 to 15.0	12 titer Interval 10.0 to 14.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[8]: Baseline	5 titer Interval 4.0 to 5.0	5 titer Interval 4.0 to 5.0	5 titer Interval 4.0 to 5.0	5 titer Interval 5.0 to 5.0	—	—	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen P[8]: Day 56	6 titer Interval 5.0 to 6.0	8 titer Interval 6.0 to 9.0	8 titer Interval 7.0 to 9.0	7 titer Interval 6.0 to 9.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and Days 56 (pre-vaccination) and 84

Population: Per-protocol population participants with valid specimens at each time point.

Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured at Baseline and 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and third injection (Day 84; primary outcome).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=135 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=137 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=132 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=137 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain Wa: Day 56	42 titer Interval 34.0 to 52.0	90 titer Interval 77.0 to 104.0	85 titer Interval 74.0 to 97.0	85 titer Interval 75.0 to 96.0	—	—	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain 1076: Day 56	12 titer Interval 10.0 to 15.0	18 titer Interval 16.0 to 22.0	18 titer Interval 15.0 to 21.0	20 titer Interval 17.0 to 23.0	—	—	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain Wa: Baseline	118 titer Interval 99.0 to 142.0	154 titer Interval 131.0 to 181.0	128 titer Interval 108.0 to 152.0	130 titer Interval 110.0 to 153.0	—	—	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain Wa: Day 84	42 titer Interval 34.0 to 52.0	90 titer Interval 77.0 to 104.0	85 titer Interval 74.0 to 97.0	85 titer Interval 75.0 to 96.0	—	—	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain DS-1: Baseline	54 titer Interval 45.0 to 64.0	51 titer Interval 41.0 to 62.0	44 titer Interval 36.0 to 54.0	46 titer Interval 38.0 to 57.0	—	—	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain DS-1: Day 56	16 titer Interval 13.0 to 19.0	26 titer Interval 22.0 to 30.0	26 titer Interval 22.0 to 31.0	27 titer Interval 23.0 to 32.0	—	—	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain DS-1: Day 84	11 titer Interval 9.0 to 13.0	49 titer Interval 42.0 to 58.0	48 titer Interval 42.0 to 55.0	53 titer Interval 46.0 to 61.0	—	—	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain 1076: Baseline	31 titer Interval 25.0 to 38.0	37 titer Interval 31.0 to 44.0	30 titer Interval 25.0 to 36.0	35 titer Interval 29.0 to 42.0	—	—	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants Strain 1076: Day 84	10 titer Interval 8.0 to 11.0	34 titer Interval 29.0 to 40.0	35 titer Interval 30.0 to 40.0	43 titer Interval 38.0 to 49.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)

Population: Safety population

Any symptom starting after 7 days post any study injection was recorded as an adverse event. A serious adverse event (SAE) is any event that occurred from the first dose of study drug that resulted in any of the following outcomes: * Death - Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital abnormality or birth defect * Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious event. AEs related to study drug were those events for which there was a reasonable possibility that the study drug caused the event In the opinion of the site investigator.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=6 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo n=139 Participants Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 n=139 Participants Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 n=140 Participants Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 n=139 Participants Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period Any serious adverse event	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	8 Participants	13 Participants	6 Participants	8 Participants
Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period Any AE related to study drug	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	3 Participants
Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period Any adverse event	2 Participants	8 Participants	11 Participants	5 Participants	9 Participants	8 Participants	132 Participants	129 Participants	134 Participants	130 Participants
Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period Any grade 2 or higher AE	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants	2 Participants	27 Participants	43 Participants	28 Participants	36 Participants
Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period Any grade 2 or higher AE related to study drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 56, pre-vaccination

Population: Per-protocol population; participants with available data for each antigen

Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the 2nd injection (Day 56). Measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for decay in maternal antibodies. The estimated maternal antibody half-life was derived from linear regression of Log2 transformed titers in placebo recipients from the combined infant cohorts.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=135 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=137 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=131 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=136 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen P[4]	7 Participants	126 Participants	121 Participants	131 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen P[6]	25 Participants	136 Participants	125 Participants	133 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen P[8]	7 Participants	126 Participants	119 Participants	131 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen Any 2 antigens	7 Participants	126 Participants	121 Participants	132 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen All 3 antigens	4 Participants	126 Participants	114 Participants	128 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 56, pre-vaccination

Population: Per-protocol population; participants with available data for each antigen

Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the second injection (Day 56). Measured by enzyme-linked immunosorbent assay (ELISA) to whole viral lysate.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=135 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=137 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=131 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=136 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen P[4]	6 Participants	22 Participants	29 Participants	20 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen P[6]	12 Participants	22 Participants	33 Participants	27 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen P[8]	6 Participants	19 Participants	22 Participants	18 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen Any 2 antigens	7 Participants	19 Participants	25 Participants	21 Participants	—	—	—	—	—	—
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen All 3 antigens	4 Participants	9 Participants	16 Participants	10 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 56, prevaccination

Population: Per-protocol population, participants with available data for each strain

Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the second injection (Day 56). Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured using a validated assay. For infants, antibody titers were adjusted for decay in maternal antibodies.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=135 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=137 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=131 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=136 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination Any 2 strains	14 Participants	35 Participants	38 Participants	37 Participants	—	—	—	—	—	—
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination Rotavirus strain Wa	16 Participants	49 Participants	51 Participants	49 Participants	—	—	—	—	—	—
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination Rotavirus strain DS-1	19 Participants	38 Participants	44 Participants	48 Participants	—	—	—	—	—	—
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination Rotavirus strain 1076	13 Participants	29 Participants	33 Participants	32 Participants	—	—	—	—	—	—
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination All 3 strains	4 Participants	12 Participants	13 Participants	13 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 84 for adults; Day 28 for toddlers

Population: Per-protocol population

Seroresponse was defined as a four-fold rise or greater in IgG antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers). Measured by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=4 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=11 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=11 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen P[4]	0 Participants	11 Participants	11 Participants	0 Participants	7 Participants	11 Participants	—	—	—	—
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen P[6]	0 Participants	10 Participants	11 Participants	0 Participants	9 Participants	11 Participants	—	—	—	—
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen P[8]	0 Participants	11 Participants	11 Participants	0 Participants	10 Participants	10 Participants	—	—	—	—
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen Any 2 antigens	0 Participants	11 Participants	11 Participants	0 Participants	9 Participants	12 Participants	—	—	—	—
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen All 3 antigens	0 Participants	10 Participants	11 Participants	0 Participants	6 Participants	8 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 84 for adults; Day 28 for toddlers

Population: Per-protocol population

Seroresponse was defined as a four-fold rise or greater in IgA antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers). Measured by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=4 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=11 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=11 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen P[4]	0 Participants	11 Participants	11 Participants	0 Participants	8 Participants	11 Participants	—	—	—	—
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen P[8]	0 Participants	11 Participants	10 Participants	0 Participants	10 Participants	10 Participants	—	—	—	—
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen P[6]	0 Participants	9 Participants	9 Participants	0 Participants	6 Participants	8 Participants	—	—	—	—
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen Any 2 antigens	0 Participants	11 Participants	10 Participants	0 Participants	9 Participants	10 Participants	—	—	—	—
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen All 3 antigens	0 Participants	9 Participants	9 Participants	0 Participants	5 Participants	8 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 84 for adults; Day 28 for toddlers

Population: Per-protocol population

Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers) for each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=4 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=11 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=11 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain Rotavirus strain Wa	0 Participants	3 Participants	8 Participants	0 Participants	1 Participants	5 Participants	—	—	—	—
Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain Rotavirus strain DS-1	0 Participants	5 Participants	4 Participants	0 Participants	1 Participants	3 Participants	—	—	—	—
Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain Rotavirus strain 1076	0 Participants	2 Participants	3 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—
Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain Any 2 strains	0 Participants	3 Participants	3 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—
Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain All 3 strains	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 28 for toddlers or Day 84 for adults

Population: Per protocol population; participants with valid specimens at each time point.

Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=6 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[4]: Baseline	425 titer Interval 198.0 to 909.0	358 titer Interval 215.0 to 596.0	444 titer Interval 314.0 to 627.0	183 titer Interval 64.0 to 523.0	195 titer Interval 89.0 to 425.0	282 titer Interval 124.0 to 642.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[4]: 28 days post-final vaccination	311 titer Interval 84.0 to 1156.0	11642 titer Interval 7560.0 to 17927.0	13337 titer Interval 8229.0 to 21616.0	174 titer Interval 57.0 to 527.0	920 titer Interval 285.0 to 2974.0	2396 titer Interval 1089.0 to 5274.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[6]: Baseline	89 titer Interval 34.0 to 232.0	251 titer Interval 90.0 to 695.0	234 titer Interval 101.0 to 541.0	58 titer Interval 20.0 to 165.0	172 titer Interval 65.0 to 457.0	150 titer Interval 86.0 to 262.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[6]: 28 days post-final vaccination	89 titer Interval 14.0 to 576.0	22120 titer Interval 12905.0 to 37916.0	29706 titer Interval 17801.0 to 49573.0	72 titer Interval 27.0 to 192.0	1767 titer Interval 468.0 to 6672.0	2515 titer Interval 884.0 to 7158.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[8]: Baseline	140 titer Interval 39.0 to 509.0	205 titer Interval 109.0 to 387.0	220 titer Interval 126.0 to 386.0	229 titer Interval 70.0 to 751.0	113 titer Interval 42.0 to 416.0	231 titer Interval 73.0 to 731.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[8]: 28 days post-final vaccination	113 titer Interval 24.0 to 529.0	11355 titer Interval 7138.0 to 18063.0	14557 titer Interval 8892.0 to 23831.0	294 titer Interval 70.0 to 1239.0	1207 titer Interval 389.0 to 3749.0	4059 titer Interval 2022.0 to 8149.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 28 for toddlers or Day 84 for adults

Population: Per-protocol population participants with valid specimens at each time point.

Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=6 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[4]: Baseline	151 titer Interval 34.0 to 676.0	186 titer Interval 78.0 to 445.0	143 titer Interval 69.0 to 297.0	174 titer Interval 32.0 to 936.0	124 titer Interval 45.0 to 338.0	49 titer Interval 18.0 to 135.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[4]: 28 days post-final vaccination	202 titer Interval 15.0 to 2654.0	4685 titer Interval 1395.0 to 15734.0	4533 titer Interval 1990.0 to 10326.0	221 titer Interval 55.0 to 897.0	629 titer Interval 204.0 to 1935.0	443 titer Interval 180.0 to 1091.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[6]: Baseline	56 titer Interval 25.0 to 127.0	120 titer Interval 56.0 to 257.0	113 titer Interval 43.0 to 296.0	16 titer Interval 5.0 to 49.0	55 titer Interval 22.0 to 137.0	15 titer Interval 9.0 to 27.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[6]: 28 days post-final vaccination	95 titer Interval 38.0 to 236.0	2470 titer Interval 796.0 to 7659.0	1864 titer Interval 505.0 to 6886.0	15 titer Interval 4.0 to 65.0	198 titer Interval 69.0 to 569.0	101 titer Interval 37.0 to 274.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[8]: Baseline	119 titer Interval 23.0 to 614.0	151 titer Interval 60.0 to 380.0	89 titer Interval 40.0 to 201.0	136 titer Interval 14.0 to 1294.0	83 titer Interval 24.0 to 293.0	41 titer Interval 13.0 to 131.0	—	—	—	—
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen P[8]: 28 days post-final vaccination	194 titer Interval 19.0 to 2010.0	3590 titer Interval 1060.0 to 12156.0	2350 titer Interval 766.0 to 7210.0	211 titer Interval 18.0 to 2480.0	928 titer Interval 324.0 to 2653.0	530 titer Interval 211.0 to 1333.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 28 for toddlers or Day 84 for adults

Population: Per-protocol population participants with valid specimens at each time point.

Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).

Outcome measures

Outcome measures
Measure	Adults: Placebo n=6 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=6 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=12 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers Strain Wa: Baseline	317 titer Interval 123.0 to 820.0	448 titer Interval 247.0 to 815.0	276 titer Interval 193.0 to 396.0	77 titer Interval 16.0 to 369.0	131 titer Interval 46.0 to 373.0	67 titer Interval 25.0 to 176.0	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers Strain Wa: 28 days post-final vaccination	244 titer Interval 80.0 to 743.0	913 titer Interval 579.0 to 1439.0	815 titer Interval 531.0 to 1251.0	78 titer Interval 16.0 to 370.0	147 titer Interval 47.0 to 459.0	253 titer Interval 119.0 to 537.0	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers Strain DS-1: Baseline	76 titer Interval 16.0 to 355.0	114 titer Interval 57.0 to 228.0	119 titer Interval 57.0 to 248.0	16 titer Interval 3.0 to 85.0	29 titer Interval 9.0 to 92.0	20 titer Interval 9.0 to 44.0	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers Strain DS-1: 28 days post-final vaccination	59 titer Interval 4.0 to 813.0	390 titer Interval 278.0 to 545.0	317 titer Interval 152.0 to 659.0	15 titer Interval 3.0 to 79.0	40 titer Interval 14.0 to 113.0	60 titer Interval 22.0 to 167.0	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers Strain 1076: Baseline	77 titer Interval 14.0 to 415.0	175 titer Interval 74.0 to 416.0	152 titer Interval 63.0 to 366.0	13 titer Interval 3.0 to 53.0	28 titer Interval 9.0 to 89.0	16 titer Interval 8.0 to 34.0	—	—	—	—
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers Strain 1076: 28 days post-final vaccination	43 titer Interval 4.0 to 428.0	354 titer Interval 180.0 to 695.0	284 titer Interval 132.0 to 607.0	15 titer Interval 3.0 to 67.0	30 titer Interval 9.0 to 99.0	25 titer Interval 11.0 to 58.0	—	—	—	—

POST_HOC outcome

Timeframe: Day 56 and Day 84

Population: Per-protocol population participants with valid specimens at each time point.

The number of adults and infants with a 4-fold or greater increase from Baseline in neutralizing antibody titers to each of the three rotavirus strains from which the vaccine antigens were derived 4 weeks after the second (Day 56) and third (Day 84) vaccinations. For infants, antibody titer was adjusted for decay in maternal antibodies.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=4 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=11 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=11 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo n=135 Participants Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 n=137 Participants Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 n=132 Participants Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo n=136 Participants Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Strain Wa: Day 84	0 Participants	2 Participants	3 Participants	17 Participants	73 Participants	95 Participants	92 Participants	—	—	—
Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Strain DS-1: Day 56	0 Participants	5 Participants	2 Participants	11 Participants	25 Participants	30 Participants	30 Participants	—	—	—
Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Strain DS-1: Day 84	0 Participants	4 Participants	4 Participants	17 Participants	85 Participants	96 Participants	93 Participants	—	—	—
Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Strain 1076: Day 84	0 Participants	2 Participants	3 Participants	13 Participants	73 Participants	86 Participants	98 Participants	—	—	—
Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Strain Wa: Day 56	0 Participants	0 Participants	4 Participants	9 Participants	31 Participants	29 Participants	23 Participants	—	—	—
Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Strain 1076: Day 56	0 Participants	1 Participants	1 Participants	7 Participants	21 Participants	20 Participants	18 Participants	—	—	—

POST_HOC outcome

Timeframe: Day 28

Population: Per-protocol population

The number of toddlers with a 4-fold or greater increase from Baseline 4 weeks after vaccination in neutralizing antibody titers to each of the three rotavirus strains from which the vaccine antigens were derived.

Outcome measures

Outcome measures
Measure	Adults: Placebo n=6 Participants Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Adults: 30 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Adults: 90 µg P2-VP8 n=12 Participants Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Toddlers: Placebo Toddlers received one intramuscular injection of placebo on Day 0.	Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.	Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.	Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.	Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Rotavirus strain Wa	0 Participants	0 Participants	4 Participants	—	—	—	—	—	—	—
Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Rotavirus strain DS-1	0 Participants	1 Participants	3 Participants	—	—	—	—	—	—	—
Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain Rotavirus strain 1076	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—

Adverse Events

Adult: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adult: P2-VP8 (30 µg)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Adult: P2-VP8 (90 µg)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Toddler: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Toddler: P2-VP8 (30 µg)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Toddler: P2-VP8 (90 µg)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Infant: Placebo

Serious events: 8 serious events

Other events: 132 other events

Deaths: 1 deaths

Infant: P2-VP8 (15 µg)

Serious events: 13 serious events

Other events: 129 other events

Deaths: 1 deaths

Infant: P2-VP8 (30 µg)

Serious events: 6 serious events

Other events: 134 other events

Deaths: 1 deaths

Infant: P2-VP8 (90 µg)

Serious events: 8 serious events

Other events: 130 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adult: Placebo n=6 participants at risk Adult participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.	Adult: P2-VP8 (30 µg) n=12 participants at risk Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.	Adult: P2-VP8 (90 µg) n=12 participants at risk Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.	Toddler: Placebo n=6 participants at risk Toddler participants who received one intramuscular injection of placebo on day 0. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.	Toddler: P2-VP8 (30 µg) n=12 participants at risk Toddler participants who received one intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) on day 0.	Toddler: P2-VP8 (90 µg) n=12 participants at risk Toddler participants who received one intramuscular injection of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) on day 0.	Infant: Placebo n=139 participants at risk Infant participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately one third of the participants were compared to the arm receiving the 15 µg dose of P2-VP8; once the safety of the 15 µg dose was established, one third of the participants were compared to the arm receiving 30 µg; and the last third were compared to the arm receiving 90 µg after the safety of the 30 µg dose was established.	Infant: P2-VP8 (15 µg) n=139 participants at risk Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (15 µg) four weeks apart on days 0, 28, and 56.	Infant: P2-VP8 (30 µg) n=140 participants at risk Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.	Infant: P2-VP8 (90 µg) n=139 participants at risk Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
General disorders Sudden infant death syndrome	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Abscess soft tissue	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Bronchiolitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	5.0% 7/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Cellulitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Encephalitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Gastroenteritis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations H1N1 influenza	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations HIV infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Lower respiratory tract infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Meningitis pneumococcal	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Pneumonia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.9% 4/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Pyelonephritis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Urinary tract infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Injury, poisoning and procedural complications Head injury	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Nervous system disorders Febrile convulsion	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Nervous system disorders Seizure	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)

Other adverse events

Other adverse events
Measure	Adult: Placebo n=6 participants at risk Adult participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.	Adult: P2-VP8 (30 µg) n=12 participants at risk Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.	Adult: P2-VP8 (90 µg) n=12 participants at risk Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.	Toddler: Placebo n=6 participants at risk Toddler participants who received one intramuscular injection of placebo on day 0. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.	Toddler: P2-VP8 (30 µg) n=12 participants at risk Toddler participants who received one intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) on day 0.	Toddler: P2-VP8 (90 µg) n=12 participants at risk Toddler participants who received one intramuscular injection of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) on day 0.	Infant: Placebo n=139 participants at risk Infant participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately one third of the participants were compared to the arm receiving the 15 µg dose of P2-VP8; once the safety of the 15 µg dose was established, one third of the participants were compared to the arm receiving 30 µg; and the last third were compared to the arm receiving 90 µg after the safety of the 30 µg dose was established.	Infant: P2-VP8 (15 µg) n=139 participants at risk Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (15 µg) four weeks apart on days 0, 28, and 56.	Infant: P2-VP8 (30 µg) n=140 participants at risk Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.	Infant: P2-VP8 (90 µg) n=139 participants at risk Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Congenital, familial and genetic disorders Cryptorchism	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Ear and labyrinth disorders Ear pain	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Eye disorders Eye discharge	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Eye disorders Eye swelling	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Eye disorders Eyelid oedema	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.1% 3/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Aphthous ulcer	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Constipation	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	3.6% 5/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.9% 4/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.6% 12/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	4.3% 6/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 1/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 2/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	18.7% 26/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.8% 15/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	11.4% 16/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	15.8% 22/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Mouth ulceration	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Oral mucosal blistering	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Toothache	16.7% 1/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Umbilical hernia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Vomiting	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	4.3% 6/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
General disorders Fatigue	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	4.3% 6/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
General disorders Influenza like illness	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 2/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
General disorders Injection site induration	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
General disorders Injection site rash	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Gastrointestinal disorders Mass	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
General disorders Pyrexia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	3.6% 5/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
General disorders Vessel puncture site bruise	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Immune system disorders Allergy to arthropod bite	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Immune system disorders Drug hypersensitivity	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Immune system disorders Food allergy	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Abscess	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.1% 3/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Abscess neck	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Acarodermatitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Body tinea	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.1% 3/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Bronchiolitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 2/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	9.4% 13/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	15.8% 22/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	14.3% 20/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	13.7% 19/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Bronchitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 1/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Candida infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Candida nappy rash	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.9% 4/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Conjunctivitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 2/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 1/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.8% 15/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	5.8% 8/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.1% 10/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.1% 14/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Conjunctivitis bacterial	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Coxsackie viral infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Dysentery	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Fungal skin infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	4.3% 6/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.1% 3/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	5.8% 8/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Furuncle	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Gastroenteritis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 1/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	6.5% 9/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	11.5% 16/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.1% 10/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.8% 15/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Hordeolum	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 1/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Impetigo	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Laryngitis	16.7% 1/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Lower respiratory tract infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	33.3% 2/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.6% 12/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.2% 10/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	5.7% 8/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	5.8% 8/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Nasopharyngitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Ophthalmia neonatorum	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Oral candidiasis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.9% 11/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.2% 10/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	6.4% 9/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.8% 15/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Otitis media	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 1/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.9% 4/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.9% 4/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Otitis media acute	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Otitis media chronic	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Pharyngitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	5.8% 8/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	3.6% 5/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Pharyngotonsillitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Pneumonia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Pulmonary tuberculosis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Rash pustular	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Immune system disorders Respiratory syncytial virus bronchiolitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Respiratory tract infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Rhinitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	18.0% 25/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	15.8% 22/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	19.3% 27/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	20.9% 29/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Sinusitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Skin candida	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Subcutaneous abscess	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Tinea capitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Tinea faciei	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Tinea infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Tonsillitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	33.3% 4/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	50.0% 6/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	33.3% 2/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	33.3% 4/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	41.7% 5/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	50.4% 70/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	60.4% 84/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	52.9% 74/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	59.0% 82/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Urinary tract infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Urinary tract infection bacterial	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Vaccination site abscess	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Varicella	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Viral diarrhoea	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Viral infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Viral rash	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.1% 3/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Investigations Cardiac murmur	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Investigations Weight decreased	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.1% 3/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Metabolism and nutrition disorders Failure to thrive	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Metabolism and nutrition disorders Malnutrition	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Metabolism and nutrition disorders Poor feeding infant	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Metabolism and nutrition disorders Weight gain poor	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 2/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Nervous system disorders Headache	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Psychiatric disorders Irritability	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.9% 4/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Psychiatric disorders Restlessness	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Reproductive system and breast disorders Gynaecomastia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Reproductive system and breast disorders Penile swelling	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Reproductive system and breast disorders Vaginal discharge	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	16.7% 2/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	6.5% 9/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.9% 11/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	12.1% 17/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.8% 15/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	20.1% 28/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	24.5% 34/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	17.1% 24/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	33.8% 47/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Blister	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	3.6% 5/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.1% 14/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	9.4% 13/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.9% 11/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	11.5% 16/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.3% 1/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	14.4% 20/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.8% 15/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	8.6% 12/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	13.7% 19/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Eczema infantile	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Milia	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.2% 3/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.9% 4/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	3.6% 5/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Pityriasis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Pityriasis alba	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.1% 14/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.2% 10/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.0% 14/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	10.1% 14/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	2.1% 3/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	12.2% 17/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	9.4% 13/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	7.1% 10/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	12.2% 17/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	4.3% 6/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	1.4% 2/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Skin depigmentation	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.72% 1/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/6 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/12 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.71% 1/140 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)	0.00% 0/139 • Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)

Additional Information

Jorge Flores

PATH

Phone: (202) 822-0033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place