Trial Outcomes & Findings for Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules (NCT NCT01266850)

Last Updated: 2014-10-28

Results Overview

Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1384 participants

Primary outcome timeframe

3-6 weeks after the last vaccination

Results posted on

2014-10-28

Participant Flow

Participants were healthy males and females age 6-14 weeks, recruited from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 24MAR2011 and 08APR2013.

Participant milestones

Participant milestones
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Overall Study STARTED	242	248	238	329	327
Overall Study Received Second Vaccine	231	233	227	311	307
Overall Study Received Third Vaccine	221	221	217	0	299
Overall Study COMPLETED	212	212	214	301	297
Overall Study NOT COMPLETED	30	36	24	28	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Overall Study Lost to Follow-up	19	19	13	13	12
Overall Study Withdrawal by Subject	8	9	6	9	12
Overall Study Physician Decision	3	6	4	4	3
Overall Study Protocol Violation	0	1	0	1	2
Overall Study Adverse Event	0	0	0	0	1
Overall Study Site Closure	0	1	1	1	0

Baseline Characteristics

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=242 Participants Participants received 2-mL RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=248 Participants Participants received 2-mL RotaTeq® orally at 2 months of age, followed by 1-mL Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=238 Participants Participants received 2-mL RotaTeq® orally at 2 and 4 months of age, followed by 1-mL Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=329 Participants Participants received 2-mL Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=327 Participants Participants received 2-mL Rotarix® orally at 2 months of age, followed by 1-mL RotaTeq® orally at 4 and 6 months of age.	Total n=1384 Participants Total of all reporting groups
Age, Continuous	9.2 weeks STANDARD_DEVIATION 1.4 • n=5 Participants	9.1 weeks STANDARD_DEVIATION 1.2 • n=7 Participants	9.2 weeks STANDARD_DEVIATION 1.2 • n=5 Participants	9.1 weeks STANDARD_DEVIATION 1.2 • n=4 Participants	9.2 weeks STANDARD_DEVIATION 1.4 • n=21 Participants	9.2 weeks STANDARD_DEVIATION 1.3 • n=8 Participants
Age, Categorical <=18 years	242 Participants n=5 Participants	248 Participants n=7 Participants	238 Participants n=5 Participants	329 Participants n=4 Participants	327 Participants n=21 Participants	1384 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	112 Participants n=7 Participants	125 Participants n=5 Participants	176 Participants n=4 Participants	149 Participants n=21 Participants	686 Participants n=8 Participants
Sex: Female, Male Male	118 Participants n=5 Participants	136 Participants n=7 Participants	113 Participants n=5 Participants	153 Participants n=4 Participants	178 Participants n=21 Participants	698 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants	8 Participants n=21 Participants	33 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants
Race (NIH/OMB) Black or African American	60 Participants n=5 Participants	57 Participants n=7 Participants	52 Participants n=5 Participants	80 Participants n=4 Participants	81 Participants n=21 Participants	330 Participants n=8 Participants
Race (NIH/OMB) White	143 Participants n=5 Participants	143 Participants n=7 Participants	139 Participants n=5 Participants	199 Participants n=4 Participants	195 Participants n=21 Participants	819 Participants n=8 Participants
Race (NIH/OMB) More than one race	30 Participants n=5 Participants	35 Participants n=7 Participants	37 Participants n=5 Participants	33 Participants n=4 Participants	41 Participants n=21 Participants	176 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	17 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=5 Participants	49 Participants n=7 Participants	45 Participants n=5 Participants	52 Participants n=4 Participants	67 Participants n=21 Participants	254 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	201 Participants n=5 Participants	199 Participants n=7 Participants	193 Participants n=5 Participants	277 Participants n=4 Participants	260 Participants n=21 Participants	1130 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	242 participants n=5 Participants	248 participants n=7 Participants	238 participants n=5 Participants	329 participants n=4 Participants	327 participants n=21 Participants	1384 participants n=8 Participants

PRIMARY outcome

Timeframe: 3-6 weeks after the last vaccination

Population: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=206 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=206 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=194 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=287 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=280 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay	186 participants	182 participants	175 participants	191 participants	261 participants

PRIMARY outcome

Timeframe: 3-6 weeks after the last vaccination

Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA 89-12 assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titier was 20 or greater.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=206 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=207 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=193 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=287 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=280 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay	159 participants	184 participants	165 participants	219 participants	256 participants

PRIMARY outcome

Timeframe: 3-6 weeks after the last dose of vaccine

Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titers. The geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=206 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=207 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=195 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=287 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=280 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Geometric Mean Serum Anti-rotavirus IgA Titer WC3 Assay	294.03 titers Interval 231.519 to 373.407	215.81 titers Interval 168.355 to 276.652	305.89 titers Interval 238.614 to 392.13	38.06 titers Interval 31.715 to 45.685	256.90 titers Interval 214.441 to 307.765
Geometric Mean Serum Anti-rotavirus IgA Titer 89-12 Assay	60.89 titers Interval 49.355 to 75.121	115.72 titers Interval 94.543 to 141.642	104.04 titers Interval 83.026 to 130.383	100.21 titers Interval 80.582 to 124.629	212.52 titers Interval 173.815 to 259.833

SECONDARY outcome

Timeframe: 3-6 weeks after the last dose of vaccine.

Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the neutralizing antibody assay against the most common rotavirus serotypes, G1-G4 and G9. Antigen-specific geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=206 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=207 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=195 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=287 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=280 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9) G1P[8] Antigen	84.5 titers Interval 68.81 to 103.72	93.6 titers Interval 76.88 to 114.02	112.0 titers Interval 89.68 to 139.84	45.3 titers Interval 39.6 to 51.75	96.6 titers Interval 81.73 to 114.24
GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9) G2P[4] Antigen	17.1 titers Interval 14.54 to 20.11	14.5 titers Interval 12.33 to 17.02	17.5 titers Interval 14.68 to 20.94	7.1 titers Interval 6.51 to 7.76	19.3 titers Interval 16.5 to 22.62
GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9) G3,P[8] Antigen	12.9 titers Interval 11.06 to 15.01	16.8 titers Interval 14.4 to 19.61	16.6 titers Interval 13.91 to 19.83	14.0 titers Interval 12.5 to 15.65	22.2 titers Interval 18.89 to 25.98
GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9) G4P[6] Antigen	18.6 titers Interval 16.08 to 21.63	17.7 titers Interval 15.18 to 20.74	21.3 titers Interval 17.92 to 25.21	7.0 titers Interval 6.49 to 7.59	19.0 titers Interval 16.58 to 21.74
GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9) G4P[8] Antigen	26.1 titers Interval 22.17 to 30.67	22.1 titers Interval 18.77 to 26.01	24.9 titers Interval 21.22 to 29.28	8.7 titers Interval 7.96 to 9.58	25.6 titers Interval 22.28 to 29.39
GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9) G9P[6] Antigen	13.1 titers Interval 11.24 to 15.38	13.5 titers Interval 11.58 to 15.75	16.1 titers Interval 13.37 to 19.37	6.8 titers Interval 6.37 to 7.34	14.5 titers Interval 12.57 to 16.69

SECONDARY outcome

Timeframe: Days 1-8 after each vaccination

Population: All participants who were vaccinated and had reactogenicity data reported are included in the analysis population.

The participants' parent/guardian was given a memory aid to record for 8 days the presence of solicited reactions of fever, diarrhea and vomiting. Fever was considered experienced if the participant was assessed with an axillary temperature of 100.4F or greater on any day in the 8-day period after any vaccination. Diarrhea was considered experienced if the participant had 3 or more looser than normal stools in a day. Vomiting was considered experienced if the participant vomited 2 or more times in a day.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=241 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=245 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=236 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=326 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=325 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination Fever	37 participants	36 participants	31 participants	29 participants	49 participants
Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination Diarrhea	22 participants	27 participants	17 participants	28 participants	32 participants
Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination Vomiting	23 participants	22 participants	18 participants	17 participants	33 participants

SECONDARY outcome

Timeframe: Day 1 through 6 months after the last vaccination

Population: All participants who were vaccinated are included in the analysis population.

Hematochezia was defined as any stools that are black and tarry; maroon in color; or frank red blood. At each visit, signs of hematochezia were assessed and the participant's parent/guardian was instructed to contact the clinical site at any time if the participant had evidence of hematochezia.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=241 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=245 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=236 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=326 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=325 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Number of Participants Experiencing Hematochezia at Any Time During the Study	5 participants	3 participants	5 participants	6 participants	13 participants

SECONDARY outcome

Timeframe: 3-6 weeks after the last dose of vaccine.

Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotypes G1, G2, G4P6 and G9. A participant met the threshold of a positive response if the post vaccination antigen-specific antibody titer was 10 or greater.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=206 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=207 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=194 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=287 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=280 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9 G1P[8] Antigen	187 participants	192 participants	176 participants	260 participants	260 participants
Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9 G2P[4] Antigen	127 participants	112 participants	116 participants	61 participants	165 participants
Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9 G4P[6] Antigen	146 participants	136 participants	145 participants	68 participants	195 participants
Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9 G9P[6] Antigen	110 participants	109 participants	112 participants	71 participants	154 participants

SECONDARY outcome

Timeframe: 3-6 weeks after the last dose of vaccine.

Blood was collected from all participants prior to vaccination and at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G3. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=205 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=207 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=194 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=287 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=280 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotype G3	108 participants	134 participants	111 participants	179 participants	189 participants

SECONDARY outcome

Timeframe: 3-6 weeks after the last dose of vaccine.

Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G4P8. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.

Outcome measures

Outcome measures
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=206 Participants Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=206 Participants Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=190 Participants Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=287 Participants Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=279 Participants Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8	161 participants	152 participants	150 participants	114 participants	216 participants

Adverse Events

Group 1: RotaTeq, RotaTeq, RotaTeq

Serious events: 11 serious events

Other events: 75 other events

Deaths: 0 deaths

Group 2: RotaTeq, Rotarix, Rotarix

Serious events: 7 serious events

Other events: 95 other events

Deaths: 0 deaths

Group 3: RotaTeq, RotaTeq, Rotarix

Serious events: 13 serious events

Other events: 98 other events

Deaths: 0 deaths

Group 4: Rotarix, Rotarix

Serious events: 11 serious events

Other events: 85 other events

Deaths: 0 deaths

Group 5: Rotarix, RotaTeq, RotaTeq

Serious events: 21 serious events

Other events: 135 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=242 participants at risk Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=248 participants at risk Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=238 participants at risk Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=329 participants at risk Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=327 participants at risk Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Congenital, familial and genetic disorders Craniosynostosis	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Gastrointestinal disorders Intussusception	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Gastrointestinal disorders Vomiting	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
General disorders Pyrexia	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.40% 1/248 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Immune system disorders Food allergy	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Abscess	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.40% 1/248 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Abscess neck	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Bacteraemia	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Bronchiolitis	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.81% 2/248 • Number of events 2 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	1.3% 3/238 • Number of events 5 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.61% 2/327 • Number of events 2 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Cellulitis of male external genital organ	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Eczema herpeticum	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Croup infectious	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Gastroenteritis	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Meningitis aseptic	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Pneumonia	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.61% 2/327 • Number of events 2 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Pneumonia bacterial	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Pyelonephritis	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.30% 1/329 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.40% 1/248 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	1.3% 3/238 • Number of events 3 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.61% 2/329 • Number of events 2 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.61% 2/327 • Number of events 2 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Respiratory tract infection	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Staphylococcal infection	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Streptococcal infection	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Subcutaneous abscess	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.40% 1/248 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Urosepsis	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.30% 1/329 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Vulval cellulitis	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.30% 1/329 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Injury, poisoning and procedural complications Injury	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.30% 1/329 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.40% 1/248 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Injury, poisoning and procedural complications Skull fracture	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Metabolism and nutrition disorders Dehydration	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.30% 1/329 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Nervous system disorders Gross motor delay	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Nervous system disorders Hemiparesis	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Respiratory, thoracic and mediastinal disorders Apparent life threatening event	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.42% 1/238 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.61% 2/329 • Number of events 2 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.30% 1/329 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.41% 1/242 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.30% 1/329 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.40% 1/248 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/327 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/242 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/248 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/238 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.00% 0/329 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.31% 1/327 • Number of events 1 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.

Other adverse events

Other adverse events
Measure	Group 1: RotaTeq, RotaTeq, RotaTeq n=242 participants at risk Participants received RotaTeq® orally at 2, 4 and 6 months of age.	Group 2: RotaTeq, Rotarix, Rotarix n=248 participants at risk Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.	Group 3: RotaTeq, RotaTeq, Rotarix n=238 participants at risk Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.	Group 4: Rotarix, Rotarix n=329 participants at risk Participants received Rotarix® orally at 2 and 4 months of age.	Group 5: Rotarix, RotaTeq, RotaTeq n=327 participants at risk Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
Infections and infestations Bronchiolitis	2.5% 6/242 • Number of events 6 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	4.4% 11/248 • Number of events 11 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	5.0% 12/238 • Number of events 14 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	0.91% 3/329 • Number of events 3 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	4.0% 13/327 • Number of events 15 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
General disorders Irritability	14.5% 35/242 • Number of events 44 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	15.3% 38/248 • Number of events 54 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	16.8% 40/238 • Number of events 51 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	16.1% 53/329 • Number of events 70 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	18.7% 61/327 • Number of events 90 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Otitis media	6.2% 15/242 • Number of events 17 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	5.6% 14/248 • Number of events 15 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	3.8% 9/238 • Number of events 11 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	1.2% 4/329 • Number of events 4 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	8.3% 27/327 • Number of events 29 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
General disorders Pyrexia	2.1% 5/242 • Number of events 5 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	3.6% 9/248 • Number of events 11 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	6.3% 15/238 • Number of events 15 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	1.8% 6/329 • Number of events 8 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	3.7% 12/327 • Number of events 13 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Skin and subcutaneous tissue disorders Rash	3.3% 8/242 • Number of events 8 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	5.2% 13/248 • Number of events 14 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	7.6% 18/238 • Number of events 18 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	2.1% 7/329 • Number of events 7 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	2.8% 9/327 • Number of events 9 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Infections and infestations Upper respiratory tract infection	11.2% 27/242 • Number of events 29 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	15.3% 38/248 • Number of events 44 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	13.0% 31/238 • Number of events 34 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	7.3% 24/329 • Number of events 24 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.	15.3% 50/327 • Number of events 61 • Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.

Additional Information

Kathryn M. Edwards, MD

Vanderbilt University Medical Center

Phone: 615-322-3078

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60