Trial Outcomes & Findings for Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine (NCT NCT02880865)

NCT ID: NCT02880865

Last Updated: 2020-10-14

Results Overview

Measles immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for measles at 56 days post-vaccination. Seropositivity was defined by a concentration of ≥ 120 mIU/mL of anti-measles neutralizing antibody titer, as measured by the plaque reduction neutralization test (PRNT) (dilution converted to concentration using the 3rd International Standard Reference serum).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 628 participants
• Primary outcome timeframe: 56 days after MMR dose 1 vaccination (Day 56)
• Results posted on: 2020-10-14

Participant Flow

Participants were enrolled at 2 health centers in the Philippines.

Filipino children aged 9 to < 10 months were randomized in a 1:1 ratio to receive measles, mumps, and rubella vaccine (MMR) and prequalified live, attenuated SA-14-4-2 Japanese encephalitis vaccine (CD-JEV) together (Group 1) or 56 days apart (Group 2). All participants received a second dose of MMR at 12 months of age.

Participant milestones

Measure	Group 1: MMR and CD-JEV Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Study STARTED	314	314
Overall Study Received MMR Dose 1	314	314
Overall Study Received CD-JEV	314	309
Overall Study Received MMR Dose 2	313	311
Overall Study COMPLETED	313	311
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Group 1: MMR and CD-JEV Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Physician Decision	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=314 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Total n=628 Participants Total of all reporting groups
Age, Continuous	9.2 months n=314 Participants	9.2 months n=314 Participants	9.2 months n=628 Participants
Sex: Female, Male Female	144 Participants n=314 Participants	157 Participants n=314 Participants	301 Participants n=628 Participants
Sex: Female, Male Male	170 Participants n=314 Participants	157 Participants n=314 Participants	327 Participants n=628 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Philippines	314 participants n=314 Participants	314 participants n=314 Participants	628 participants n=628 Participants

PRIMARY outcome

Timeframe: 56 days after MMR dose 1 vaccination (Day 56)

Population: The measles per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid measles serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show measles seropositivity at baseline.

Measles immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for measles at 56 days post-vaccination. Seropositivity was defined by a concentration of ≥ 120 mIU/mL of anti-measles neutralizing antibody titer, as measured by the plaque reduction neutralization test (PRNT) (dilution converted to concentration using the 3rd International Standard Reference serum).

Outcome measures

Measure	Group 1: MMR and CD-JEV n=311 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=306 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination	98.1 percentage of participants Interval 95.8 to 99.3	98.0 percentage of participants Interval 95.8 to 99.3	—	—	—	—

PRIMARY outcome

Timeframe: 56 days after MMR dose 1 vaccination (Day 56)

Population: The rubella per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid rubella serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show rubella seropositivity at baseline.

Rubella immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for rubella at 56 days post-vaccination. Seropositivity was defined as antirubella immunoglobulin G (IgG) concentration of ≥ 10 IU/mL (corresponding to an optical density ratio ≥ 1.10) using a commercial IgG enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Group 1: MMR and CD-JEV n=285 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=295 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination	100.0 percentage of participants Interval 98.7 to 100.0	99.7 percentage of participants Interval 98.1 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: 56 days after MMR dose 1 vaccination (Day 56)

Population: The mumps per-protocol population included participants who fulfilled eligibility criteria, received all study vaccines as assigned, provided valid mumps serology results at baseline and Day 56, did not take any prohibited concomitant medications within within 28 days post-vaccination, and did not show mumps seropositivity at baseline.

Mumps immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for mumps at 56 days post-vaccination. Seropositivity was defined as an optical density ratio ≥ 1.10 using a commercial ELISA.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=270 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=265 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination	98.5 percentage of participants Interval 96.3 to 99.6	98.5 percentage of participants Interval 96.2 to 99.6	—	—	—	—

SECONDARY outcome

Timeframe: 56 days after MMR dose 1 vaccination (Day 56)

Population: The measles per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid measles serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show measles seropositivity at baseline.

Anti-measles neutralizing antibody concentration was measured by the plaque reduction neutralization test (PRNT).

Outcome measures

Measure	Group 1: MMR and CD-JEV n=311 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=306 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination	1964.4 mIU/mL Interval 1769.3 to 2181.0	1866.3 mIU/mL Interval 1649.1 to 2112.0	—	—	—	—

SECONDARY outcome

Timeframe: 56 days after MMR dose 1 vaccination (Day 56)

Population: The rubella per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid rubella serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show rubella seropositivity at baseline.

Anti-rubella immunoglobulin G (IgG) concentration was measured using a commercial IgG enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Group 1: MMR and CD-JEV n=285 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=295 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination	230.8 IU/mL Interval 214.4 to 248.5	229.8 IU/mL Interval 210.0 to 251.3	—	—	—	—

SECONDARY outcome

Timeframe: 56 days after MMR dose 1 vaccination (Day 56)

Population: The measles per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid measles serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show measles seropositivity at baseline.

The seroconversion rate for measles at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination or a four-fold rise in concentration 56 days after vaccination if seropositive for measles at baseline. Seropositivity was defined by a concentration of ≥ 120 mIU/mL of anti-measles neutralizing antibody titer, as measured by the plaque reduction neutralization test (PRNT).

Outcome measures

Measure	Group 1: MMR and CD-JEV n=311 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=306 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Seroconversion Rate for Measles 56 Days Post-vaccination	98.1 percentage of participants Interval 95.8 to 99.3	98.0 percentage of participants Interval 95.8 to 99.3	—	—	—	—

SECONDARY outcome

Timeframe: 56 days after MMR dose 1 vaccination (Day 56)

Population: The mumps per-protocol population included participants who fulfilled eligibility criteria, received all study vaccines as assigned, provided valid mumps serology results at baseline and Day 56, did not take any prohibited concomitant medications within within 28 days post-vaccination, and did not show mumps seropositivity at baseline.

The seroconversion rate for mumps at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination. Seropositivity was defined as an optical density ratio ≥ 1.10, measured using a commercial ELISA. Participants with equivocal serostatus at baseline are counted as non-responders.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=270 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=265 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Seroconversion Rate for Mumps 56 Days Post-vaccination	96.7 percentage of participants Interval 93.8 to 98.5	95.1 percentage of participants Interval 91.8 to 97.4	—	—	—	—

SECONDARY outcome

Timeframe: 56 days after MMR dose 1 vaccination (Day 56)

Population: The rubella per-protocol population included participants who fulfilled the eligibility criteria, received all study vaccines as assigned, provided valid rubella serology results at baseline and Day 56, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show rubella seropositivity at baseline.

The seroconversion rate for rubella at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination or a four-fold rise in concentration 56 days after vaccination if seropositive for rubella at baseline. Seropositivity is defined as a post-vaccination concentration of ≥ 10 IU/mL measured using a commercial ELISA.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=285 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=295 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Seroconversion Rate for Rubella 56 Days Post-vaccination	100.0 percentage of participants Interval 98.7 to 100.0	99.7 percentage of participants Interval 98.1 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2)

Population: The JE per-protocol population included participants who fulfilled eligibility criteria, received all study vaccines as assigned, provided valid JE serology results at baseline and 28 days post-vaccination with CD-JEV, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show JE seropositivity at baseline

Japanese encephalitis (JE) immunogenicity was assessed by the percentage of participants with demonstrated seropositivity 28 days after CD-JEV vaccination. Seropositivity was defined as an anti-JE serum neutralizing antibody titer of ≥ 1:10, as measured by JE PRNT-50.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=305 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination	72.3 percentage of participants Interval 67.0 to 77.2	68.2 percentage of participants Interval 62.6 to 73.4	—	—	—	—

SECONDARY outcome

Timeframe: 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2)

Population: The JE per-protocol population included participants who fulfilled eligibility criteria, received all study vaccines as assigned, provided valid JE serology results at baseline and 28 days post-vaccination with CD-JEV, did not take any prohibited concomitant medications within 28 days post-vaccination, and did not show JE seropositivity at baseline

Anti-JE serum neutralizing antibody titer was measured using JE PRNT-50.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=305 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination	24.0 titer Interval 20.8 to 27.6	20.3 titer Interval 17.8 to 23.1	—	—	—	—

SECONDARY outcome

Timeframe: 30 minutes following each study vaccination

Population: The safety population included all participants who received a study vaccine and had at least one safety measure post-vaccination.

Participants were observed for 30 minutes after each vaccination for immediate reactions. Immediate reactions included both local (injection site) and systemic reactions. MMR vaccine was injected on left upper thigh and CD-JEV was injected on right upper thigh.

Serious reactions were those meeting one of the following conditions:

• Death.
• Life threatening
• Required inpatient hospitalization or prolongation of existing hospitalization.
• Resulted in a persistent or significant disability or incapacity.
• Important medical events that, based upon appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=314 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV n=309 Participants Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 n=313 Participants Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 n=311 Participants Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination Any immediate reaction	6 Participants	3 Participants	5 Participants	5 Participants	3 Participants	—
Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination MMR local reaction	3 Participants	2 Participants	—	3 Participants	1 Participants	—
Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination CD-JEV local reaction	3 Participants	—	4 Participants	—	—	—
Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination Systemic	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	—
Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination Serious reactions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 30 minutes through 14 days following each vaccination

Population: Safety population

Reactogenicity post-vaccination was assessed from 30 minutes through 14 days following vaccination.

Parents used a structured reactogenicity diary card to record the following solicited (pre-listed) local and system reactions.

Local reactions (at injection site):

• Ecchymosis (bruising)
• Erythema (redness)
• Edema (swelling)
• Induration (hardness)
• Pain/tenderness

Systemic reactions:

• Fever
• Rash
• Cough
• Runny nose
• Change in eating habits
• Diarrhea
• Sleepiness
• Irritability
• Unusual crying
• Vomiting

Outcome measures

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=314 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV n=309 Participants Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 n=313 Participants Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 n=311 Participants Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination Any local reactions at CD-JEV injection site	34 Participants	—	13 Participants	—	—	—
Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination Any systemic reactions	224 Participants	222 Participants	190 Participants	168 Participants	174 Participants	—
Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination Any local reactions at MMR injection site	35 Participants	31 Participants	—	12 Participants	9 Participants	—

SECONDARY outcome

Timeframe: 30 minutes through 14 days following each vaccination

Population: Safety population

Parents recorded local reactions on a diary card.

Local ecchymosis, erythema, edema, and induration were graded as follows:

Grade 1: ≤2.5 cm in diameter.

Grade 2: >2.5 cm in diameter with 50% of surface area of extremity segment involved.

Grade 3: ≥50% surface area of extremity segment involved OR ulceration OR secondary infection OR phlebitis OR sterile abscess OR drainage.

Grade 4: potentially life-threatening (e.g., abscess, exfoliative dermatitis, necrosis involving dermis or deeper tissue).

Injection site pain/tenderness (pain without touching or tenderness when the area is touched) were graded as follows:

Grade 1: pain/tenderness causing no or minimal limitation of use of limb. Grade 2: pain/tenderness causing greater than minimal limitation of use of limb.

Grade 3: pain/tenderness causing inability to perform usual social and functional activities.

Grade 4: pain/tenderness causing inability to perform basic self-care OR hospitalization indicated.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=314 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV n=314 Participants Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 n=309 Participants Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 n=313 Participants Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 n=311 Participants Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Ecchymosis: Any	6 Participants	6 Participants	10 Participants	3 Participants	0 Participants	5 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Ecchymosis: Grade 1	6 Participants	6 Participants	10 Participants	3 Participants	0 Participants	5 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Ecchymosis: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Ecchymosis: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Erythema: Any	15 Participants	13 Participants	14 Participants	8 Participants	5 Participants	7 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Erythema: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Edema: Any	6 Participants	3 Participants	7 Participants	5 Participants	0 Participants	4 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Edema: Grade 1	5 Participants	3 Participants	7 Participants	5 Participants	0 Participants	4 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Edema: Grade 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Induration: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Induration: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Pain/Tenderness: Any	18 Participants	18 Participants	19 Participants	6 Participants	8 Participants	5 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Pain/Tenderness: Grade 1	17 Participants	17 Participants	17 Participants	5 Participants	8 Participants	4 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Pain/Tenderness: Grade 2	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Pain/Tenderness: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Pain/Tenderness: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Erythema: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Ecchymosis: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Erythema: Grade 1	15 Participants	12 Participants	14 Participants	8 Participants	5 Participants	7 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Erythema: Grade 2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Edema: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Edema: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Induration: Any	4 Participants	7 Participants	7 Participants	4 Participants	0 Participants	3 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Induration: Grade 1	4 Participants	6 Participants	7 Participants	4 Participants	0 Participants	3 Participants
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity Induration: Grade 2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 minutes through 14 days following each vaccination

Population: Safety population

Parents recorded systemic reactions on a diary card.

Fever was recorded and graded as follows (axillary temperature):

Grade 1: 37.5°C to 37.9°C

Grade 2: 38.0°C to 38.4°C

Grade 3: 38.5°C to 40.0°C

Grade 4: >40.0°C

Rash, cough, runny nose, change in eating habits, diarrhea, sleepiness, irritability, unusual crying, vomiting, and any other unsolicited reaction occurring from 30 minutes through 14 days post vaccination were graded as follows:

Grade 1: symptoms causing no or minimal interference with usual social and functional activities.

Grade 2: symptoms causing greater than minimal interference with usual social and functional activities.

Grade 3: symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated.

Grade 4: symptoms causing inability to perform basic self-care functions OR medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=314 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV n=309 Participants Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 n=313 Participants Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 n=311 Participants Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Fever: Any	135 Participants	119 Participants	87 Participants	79 Participants	84 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Fever: Grade 1	52 Participants	35 Participants	39 Participants	31 Participants	25 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Fever: Grade 2	38 Participants	43 Participants	21 Participants	23 Participants	26 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Fever: Grade 3	44 Participants	40 Participants	26 Participants	25 Participants	32 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Fever: Grade 4	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Rash: Any	27 Participants	33 Participants	13 Participants	19 Participants	18 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Rash: Grade 1	23 Participants	28 Participants	12 Participants	16 Participants	16 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Rash: Grade 2	3 Participants	4 Participants	1 Participants	2 Participants	2 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Rash: Grade 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Rash: Grade 4	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Cough: Any	127 Participants	116 Participants	118 Participants	111 Participants	103 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Cough: Grade 1	103 Participants	92 Participants	98 Participants	95 Participants	90 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Cough: Grade 2	20 Participants	22 Participants	18 Participants	16 Participants	13 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Cough: Grade 3	4 Participants	2 Participants	2 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Cough: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Runny nose: Any	167 Participants	163 Participants	143 Participants	133 Participants	135 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Runny nose: Grade 1	139 Participants	138 Participants	128 Participants	117 Participants	119 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Runny nose: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Change in eating habits: Any	49 Participants	32 Participants	27 Participants	36 Participants	27 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Change in eating habits: Grade 1	40 Participants	25 Participants	23 Participants	29 Participants	21 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Change in eating habits: Grade 2	9 Participants	6 Participants	4 Participants	6 Participants	5 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Change in eating habits: Grade 3	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Change in eating habits: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Diarrhea: Any	58 Participants	49 Participants	29 Participants	34 Participants	36 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Diarrhea: Grade 1	49 Participants	45 Participants	23 Participants	30 Participants	25 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Diarrhea: Grade 2	7 Participants	2 Participants	5 Participants	1 Participants	9 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Diarrhea: Grade 3	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Diarrhea: Grade 4	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Sleepiness: Any	43 Participants	32 Participants	12 Participants	15 Participants	16 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Sleepiness: Grade 1	39 Participants	29 Participants	12 Participants	15 Participants	15 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Sleepiness: Grade 2	4 Participants	3 Participants	0 Participants	0 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Sleepiness: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Sleepiness: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Irritability: Any	80 Participants	63 Participants	36 Participants	46 Participants	33 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Irritability: Grade 1	63 Participants	51 Participants	32 Participants	40 Participants	30 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Irritability: Grade 2	14 Participants	10 Participants	4 Participants	4 Participants	2 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Irritability: Grade 3	3 Participants	2 Participants	0 Participants	2 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Irritability: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Unusual crying: Any	54 Participants	29 Participants	20 Participants	29 Participants	20 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Unusual crying: Grade 1	45 Participants	23 Participants	17 Participants	24 Participants	16 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Unusual crying: Grade 2	8 Participants	5 Participants	3 Participants	5 Participants	3 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Unusual crying: Grade 3	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Unusual crying: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Vomiting: Any grade	29 Participants	26 Participants	21 Participants	22 Participants	31 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Vomiting: Grade 1	25 Participants	18 Participants	17 Participants	16 Participants	20 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Vomiting: Grade 2	4 Participants	8 Participants	4 Participants	3 Participants	9 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Vomiting Grade 3	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Vomiting: Grade 4	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Runny nose: Grade 2	26 Participants	23 Participants	14 Participants	14 Participants	16 Participants	—
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity Runny nose: Grade 3	2 Participants	2 Participants	1 Participants	2 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 28 days following each vaccination

Population: Safety population

Each adverse event (AE) was assessed for relationship to vaccine by the study clinician according to the following:

Definitely Related: An adverse event or unanticipated problem clearly related to the research procedures.

Possibly Related: There is a reasonable possibility that the adverse event or unanticipated problem, incident, experience, or outcome may have been caused by the procedures involved in the research.

Not Related: Any adverse event or unanticipated problem clearly not related to study procedures.

Related adverse events includes events that were assessed as definitely or possibly related.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=314 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV n=309 Participants Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 n=313 Participants Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 n=311 Participants Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination Any adverse event	207 Participants	211 Participants	164 Participants	110 Participants	148 Participants	—
Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination Related adverse events	35 Participants	22 Participants	20 Participants	22 Participants	30 Participants	—

SECONDARY outcome

Timeframe: Up to 112 days

Population: Safety population

A serious adverse event (SAE) was defined as an AE that met one of the following:

• Death
• Life threatening
• Required inpatient hospitalization or prolongation of existing hospitalization
• Resulted in persistent or significant disability or incapacity
• Important medical events that, based upon appropriate medical judgment, jeopardized the participant and required medical or surgical intervention to prevent an outcomes listed above

AEs were assessed for relationship to vaccine by the study clinician according to the following:

Definitely Related: An AE or unanticipated problem clearly related to the research procedures.

Possibly Related: There is a reasonable possibility that the AE or unanticipated problem, incident, experience, or outcome may have been caused by the procedures involved in the research.

Not Related: Any AE or unanticipated problem clearly not related to study procedures.

Related SAEs includes events that were assessed as definitely or possibly related.

Outcome measures

Measure	Group 1: MMR and CD-JEV n=314 Participants Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: MMR Then CD-JEV n=314 Participants Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).	Group 2: CD-JEV Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
Number of Participants With Serious Adverse Events Throughout the Study Any serious adverse event	8 Participants	15 Participants	—	—	—	—
Number of Participants With Serious Adverse Events Throughout the Study Related serious adverse event	0 Participants	0 Participants	—	—	—	—

Adverse Events

Group 1: MMR Dose 1 + CD-JEV

Serious events: 6 serious events

Other events: 207 other events

Deaths: 0 deaths

Group 2: MMR Dose 1

Serious events: 12 serious events

Other events: 211 other events

Deaths: 0 deaths

Group 2: CD-JEV

Serious events: 3 serious events

Other events: 164 other events

Deaths: 0 deaths

Group 1: MMR Dose 2

Serious events: 2 serious events

Other events: 110 other events

Deaths: 0 deaths

Group 2: MMR Dose 2

Serious events: 1 serious events

Other events: 147 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: MMR Dose 1 + CD-JEV n=314 participants at risk Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0.	Group 2: MMR Dose 1 n=314 participants at risk Participants in Group 2 received one dose of MMR vaccine at Day 0.	Group 2: CD-JEV n=309 participants at risk Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 n=313 participants at risk Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 n=311 participants at risk Participants in Group 2 received a second dose of MMR vaccine on Day 84.
Infections and infestations Amoebiasis	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Bronchitis	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Gastroenteritis	1.6% 5/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Urinary tract infection	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Metabolism and nutrition disorders Food intolerance	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Nervous system disorders Febrile convulsion	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Pneumonia	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.

Other adverse events

Measure	Group 1: MMR Dose 1 + CD-JEV n=314 participants at risk Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0.	Group 2: MMR Dose 1 n=314 participants at risk Participants in Group 2 received one dose of MMR vaccine at Day 0.	Group 2: CD-JEV n=309 participants at risk Participants in Group 2 received one dose of CD-JEV on Day 56.	Group 1: MMR Dose 2 n=313 participants at risk Participants in Group 1 received a second dose of MMR vaccine on Day 84.	Group 2: MMR Dose 2 n=311 participants at risk Participants in Group 2 received a second dose of MMR vaccine on Day 84.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Eye disorders Blepharitis	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Gastrointestinal disorders Aphthous ulcer	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Gastrointestinal disorders Abdominal pain	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Gastrointestinal disorders Constipation	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Gastrointestinal disorders Dyspepsia	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Gastrointestinal disorders Stomatitis	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Gastrointestinal disorders Teething	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Gastrointestinal disorders Vomiting	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
General disorders Pyrexia	1.3% 4/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.6% 5/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	2.6% 8/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.6% 5/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
General disorders Injection site induration	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Immune system disorders Allergy to arthropod sting	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Immune system disorders Hypersensitivity	1.3% 4/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Immune system disorders Food allergy	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Abscess	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Body tinea	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Bronchiolitis	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.6% 5/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Bronchitis	5.1% 16/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	7.6% 24/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	6.5% 20/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	4.2% 13/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	4.8% 15/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Bullous impetigo	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Carbuncle	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Conjunctivitis	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.3% 4/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Cellulitis orbital	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Conjunctivitis bacterial	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Conjunctivitis viral	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Dermatitis infected	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Exanthema subitum	1.6% 5/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.9% 6/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Erythema infectiosum	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Folliculitis	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Gastroenteritis	9.9% 31/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	7.0% 22/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	6.1% 19/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	3.2% 10/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	7.7% 24/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Gastroenteritis viral	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Hand-foot-and-mouth disease	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.9% 6/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	2.6% 8/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.6% 5/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Herpangina	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Hordeolum	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Impetigo	1.9% 6/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.3% 4/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Ludwig angina	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Nasopharyngitis	6.7% 21/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	6.1% 19/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	5.2% 16/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.6% 5/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	4.2% 13/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Oral candidiasis	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Otitis media	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Otitis externa	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Otitis media acute	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.97% 3/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Parasitic gastroenteritis	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Pharyngotonsillitis	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Pneumonia	3.5% 11/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	2.9% 9/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.9% 6/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	2.9% 9/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.6% 5/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Respiratory tract infection	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Rhinitis	9.9% 31/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	12.4% 39/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	11.0% 34/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	5.4% 17/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	6.8% 21/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Roseola	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Subcutaneous abscess	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Tinea cruris	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Tinea versicolour	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Upper respiratory tract infection	24.2% 76/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	24.5% 77/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	17.5% 54/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	12.8% 40/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	19.9% 62/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Upper respiratory tract infection bacterial	1.9% 6/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.3% 4/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Urinary tract infection	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Varicella	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.3% 4/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.97% 3/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Viral infection	7.6% 24/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	6.7% 21/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	3.9% 12/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	2.6% 8/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.9% 6/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Viral rash	1.6% 5/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.6% 5/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.3% 4/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Viral upper respiratory tract infection	2.5% 8/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	2.9% 9/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Infections and infestations Wound infection	1.9% 6/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.97% 3/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Anal injury	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Animal bite	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Burns second degree	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Contusion	0.96% 3/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Head injury	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Skin abrasion	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Thermal burn	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Injury, poisoning and procedural complications Wound	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Metabolism and nutrition disorders Food intolerance	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Metabolism and nutrition disorders Irritability	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Nervous system disorders Febrile convulsion	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Psychiatric disorders Breath holding	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Respiratory, thoracic and mediastinal disorders Allergic cough	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.65% 2/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	1.3% 4/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Dermatitis contact	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.97% 3/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Miliaria	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.96% 3/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.64% 2/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/314 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/309 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.32% 1/313 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.	0.00% 0/311 • Mortality and serious adverse events were collected through the end of study, up to 112 days. Non-serious adverse events were collected through 28 days after each vaccination.

Additional Information

Jorge Flores, MD

PATH

Phone: (202) 822-0033

Email: jeflores@path.org

Results disclosure agreements

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