Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005) (NCT NCT01337167)
NCT ID: NCT01337167
Last Updated: 2018-11-15
Results Overview
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1473 participants
Primary outcome timeframe
Postdose 3 (Month 7)
Results posted on
2018-11-15
Participant Flow
The infant series of vaccinations were those administered at 2, 4, and 6 months of age; the toddler vaccinations were those administered at 15 months of age. The Interim Period is the time between the last vaccination of the infant series and the time of administration of the toddler vaccination.
Participant milestones
| Measure |
V419
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Infant Series
STARTED
|
986
|
487
|
|
Infant Series
COMPLETED
|
924
|
460
|
|
Infant Series
NOT COMPLETED
|
62
|
27
|
|
Interim Period
STARTED
|
924
|
460
|
|
Interim Period
COMPLETED
|
843
|
420
|
|
Interim Period
NOT COMPLETED
|
81
|
40
|
|
Toddler Vaccinations
STARTED
|
843
|
420
|
|
Toddler Vaccinations
COMPLETED
|
829
|
407
|
|
Toddler Vaccinations
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
| Measure |
V419
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Infant Series
Adverse Event
|
1
|
1
|
|
Infant Series
Death
|
1
|
1
|
|
Infant Series
Lost to Follow-up
|
13
|
7
|
|
Infant Series
Non-compliance with study drug
|
2
|
1
|
|
Infant Series
Physician Decision
|
3
|
1
|
|
Infant Series
Protocol Violation
|
22
|
9
|
|
Infant Series
Withdrawal by Subject
|
15
|
4
|
|
Infant Series
Randomized but not vaccinated
|
5
|
3
|
|
Interim Period
Lost to Follow-up
|
51
|
23
|
|
Interim Period
Non-compliance with study drug
|
1
|
0
|
|
Interim Period
Physician Decision
|
6
|
3
|
|
Interim Period
Protocol Violation
|
5
|
3
|
|
Interim Period
Withdrawal by Subject
|
18
|
10
|
|
Interim Period
Other protocol criterion not met
|
0
|
1
|
|
Toddler Vaccinations
Lost to Follow-up
|
11
|
12
|
|
Toddler Vaccinations
Protocol Violation
|
0
|
1
|
|
Toddler Vaccinations
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
Baseline characteristics by cohort
| Measure |
V419
n=986 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=487 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Total
n=1473 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 Days
STANDARD_DEVIATION 7.5 • n=39 Participants
|
65.0 Days
STANDARD_DEVIATION 6.9 • n=41 Participants
|
65.4 Days
STANDARD_DEVIATION 7.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
479 Participants
n=39 Participants
|
214 Participants
n=41 Participants
|
693 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
507 Participants
n=39 Participants
|
273 Participants
n=41 Participants
|
780 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer \>=0.15 μg/mL and \>=1.0 μg/mL.
Outcome measures
| Measure |
V419
n=765 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=382 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
Titer >=1.0 μg/mL
|
84.97 Percentage of participants
Interval 82.24 to 87.43
|
75.39 Percentage of participants
Interval 70.76 to 79.63
|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
Titer >=0.15 μg/mL
|
97.25 Percentage of participants
Interval 95.83 to 98.29
|
92.41 Percentage of participants
Interval 89.28 to 94.86
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer \>=10 milli International units (mIU)/mL.
Outcome measures
| Measure |
V419
n=688 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=353 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Hepatitis B Surface Antigen
|
99.42 Percentage of participants
Interval 98.52 to 99.84
|
98.58 Percentage of participants
Interval 96.73 to 99.54
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer \>=0.1 International unit (IU)/mL.
Outcome measures
| Measure |
V419
n=786 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=393 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Diphtheria Toxin
|
82.44 Percentage of participants
Interval 79.6 to 85.04
|
86.26 Percentage of participants
Interval 82.45 to 89.51
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL.
Outcome measures
| Measure |
V419
n=787 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=390 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Tetanus Toxin
|
99.87 Percentage of participants
Interval 99.29 to 100.0
|
99.49 Percentage of participants
Interval 98.16 to 99.94
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Outcome measures
| Measure |
V419
n=796 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=391 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Pertussis Toxin
|
98.12 Percentage of participants
Interval 96.91 to 98.94
|
98.47 Percentage of participants
Interval 96.69 to 99.43
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Outcome measures
| Measure |
V419
n=796 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=391 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
|
87.31 Percentage of participants
Interval 84.8 to 89.55
|
92.07 Percentage of participants
Interval 88.93 to 94.55
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Outcome measures
| Measure |
V419
n=794 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=390 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Pertussis Pertactin
|
79.35 Percentage of participants
Interval 76.36 to 82.11
|
82.05 Percentage of participants
Interval 77.88 to 85.73
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Outcome measures
| Measure |
V419
n=796 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=391 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Pertussis Fimbriae
|
90.20 Percentage of participants
Interval 87.92 to 92.18
|
86.19 Percentage of participants
Interval 82.37 to 89.45
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer \>=8.
Outcome measures
| Measure |
V419
n=806 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=398 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Poliovirus Type 1
|
100.00 Percentage of participants
Interval 99.54 to 100.0
|
98.24 Percentage of participants
Interval 96.41 to 99.29
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer \>=8.
Outcome measures
| Measure |
V419
n=801 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=399 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Poliovirus Type 2
|
100.00 Percentage of participants
Interval 99.54 to 100.0
|
99.75 Percentage of participants
Interval 98.61 to 99.99
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer \>=8.
Outcome measures
| Measure |
V419
n=790 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=396 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Poliovirus Type 3
|
100.00 Percentage of participants
Interval 99.53 to 100.0
|
99.75 Percentage of participants
Interval 98.6 to 99.99
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).
Outcome measures
| Measure |
V419
n=810 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=400 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Pertussis Toxin
|
110.40 EU/mL
Interval 105.78 to 115.21
|
86.54 EU/mL
Interval 81.87 to 91.48
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Outcome measures
| Measure |
V419
n=810 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=400 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
|
48.17 EU/mL
Interval 45.68 to 50.8
|
74.44 EU/mL
Interval 68.99 to 80.33
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Outcome measures
| Measure |
V419
n=808 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=400 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
|
56.22 EU/mL
Interval 51.93 to 60.85
|
66.16 EU/mL
Interval 59.5 to 73.57
|
PRIMARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Outcome measures
| Measure |
V419
n=809 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=400 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
|
235.62 EU/mL
Interval 221.43 to 250.73
|
185.54 EU/mL
Interval 169.33 to 203.31
|
PRIMARY outcome
Timeframe: Postdose 4 (Month 16)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Outcome measures
| Measure |
V419
n=701 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=349 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Pertussis Toxin
|
99.29 Percentage of participants
Interval 98.34 to 99.77
|
97.42 Percentage of participants
Interval 95.16 to 98.81
|
PRIMARY outcome
Timeframe: Postdose 4 (Month 16)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Outcome measures
| Measure |
V419
n=699 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=350 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
|
94.42 Percentage of participants
Interval 92.45 to 96.0
|
93.14 Percentage of participants
Interval 89.97 to 95.56
|
PRIMARY outcome
Timeframe: Postdose 4 (Month 16)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Outcome measures
| Measure |
V419
n=701 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=351 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Pertussis Pertactin
|
93.01 Percentage of participants
Interval 90.86 to 94.78
|
93.45 Percentage of participants
Interval 90.33 to 95.8
|
PRIMARY outcome
Timeframe: Postdose 4 (Month 16)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Outcome measures
| Measure |
V419
n=700 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=351 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Responding to Pertussis Fimbriae
|
97.29 Percentage of participants
Interval 95.79 to 98.36
|
91.17 Percentage of participants
Interval 87.7 to 93.92
|
PRIMARY outcome
Timeframe: Postdose 4 (Month 16)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.
Outcome measures
| Measure |
V419
n=713 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=356 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Pertussis Toxin
|
127.22 EU/mL
Interval 121.17 to 133.57
|
91.31 EU/mL
Interval 85.09 to 97.98
|
PRIMARY outcome
Timeframe: Postdose 4 (Month 16)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Outcome measures
| Measure |
V419
n=710 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=357 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
|
88.92 EU/mL
Interval 84.06 to 94.05
|
89.18 EU/mL
Interval 82.54 to 96.35
|
PRIMARY outcome
Timeframe: Postdose 4 (Month 16)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Outcome measures
| Measure |
V419
n=713 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=358 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
|
108.05 EU/mL
Interval 99.88 to 116.9
|
139.35 EU/mL
Interval 124.81 to 155.58
|
PRIMARY outcome
Timeframe: Postdose 4 (Month 16)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Outcome measures
| Measure |
V419
n=713 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=358 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
|
658.50 EU/mL
Interval 617.53 to 702.2
|
414.66 EU/mL
Interval 371.41 to 462.94
|
SECONDARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.
Outcome measures
| Measure |
V419
n=765 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=382 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
|
5.11 μg/mL
Interval 4.55 to 5.73
|
3.18 μg/mL
Interval 2.66 to 3.81
|
SECONDARY outcome
Timeframe: Postdose 3 (Month 7)Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.
Outcome measures
| Measure |
V419
n=522 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=274 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus
|
278.19 units/mL
Interval 246.99 to 313.32
|
274.46 units/mL
Interval 232.83 to 323.52
|
SECONDARY outcome
Timeframe: Up to 5 days after any infant vaccination (up to 6 months)Population: Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, \>5 cm. Grade 3 Solicited systemic reactions: Pyrexia, \>=39.5°C (\>=103.1°F) rectal; Vomiting, \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses \>=3 feeds or refuses most feeds; Irritability, Inconsolable.
Outcome measures
| Measure |
V419
n=981 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=484 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 injection-site pain
|
5.9 Percentage of participants
|
4.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 irritability
|
7.7 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any injection-site pain
|
73.4 Percentage of participants
|
71.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any injection-site erythema
|
48.8 Percentage of participants
|
42.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 injection-site erythema
|
0.2 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any injection-site swelling
|
40.1 Percentage of participants
|
34.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 injection-site swelling
|
0.3 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any pyrexia
|
47.4 Percentage of participants
|
34.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 pyrexia
|
1.5 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any vomiting
|
25.7 Percentage of participants
|
21.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 vomiting
|
0.4 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any crying abnormal
|
74.8 Percentage of participants
|
72.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 crying abnormal
|
7.9 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any somnolence
|
74.1 Percentage of participants
|
71.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 somnolence
|
3.5 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any decreased appetite
|
48.9 Percentage of participants
|
43.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Grade 3 decreased appetite
|
1.3 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Any irritability
|
83.1 Percentage of participants
|
81.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after any infant vaccination (up to 6 months)Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
Outcome measures
| Measure |
V419
n=981 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=484 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any pyrexia
|
45.1 Percentage of participants
|
32.1 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any irritability
|
79.6 Percentage of participants
|
77.4 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any vomiting
|
20.8 Percentage of participants
|
16.4 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any crying abnormal
|
71.4 Percentage of participants
|
68.5 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any somnolence
|
68.5 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any decreased appetite
|
45.7 Percentage of participants
|
40.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after each infant vaccination (up to 6 months)Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
Outcome measures
| Measure |
V419
n=981 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=484 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any pyrexia, vaccination 1
|
16.1 Percentage of participants
|
12.6 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any pyrexia, vaccination 2 (N=950, 472)
|
26.6 Percentage of participants
|
16.4 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any decreased appetite, vaccination 2 (N=950, 472)
|
24.1 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any pyrexia, vaccination 3 (N=924, 460)
|
26.6 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any vomiting, vaccination 1
|
11.2 Percentage of participants
|
7.9 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any vomiting, vaccination 2 (N=950, 472)
|
10.2 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any vomiting, vaccination 3 (N=924, 460)
|
8.0 Percentage of participants
|
4.6 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any crying abnormal, vaccination 1
|
50.9 Percentage of participants
|
48.7 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any crying abnormal, vaccination 2 (N=950, 472)
|
48.4 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any crying abnormal, vaccination 3 (N=924, 460)
|
42.0 Percentage of participants
|
36.1 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any somnolence, vaccination 1
|
54.6 Percentage of participants
|
54.0 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any somnolence, vaccination 2 (N=950, 472)
|
42.9 Percentage of participants
|
41.4 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any somnolence, vaccination 3 (N=924, 460)
|
38.3 Percentage of participants
|
35.0 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any decreased appetite, vaccination 1
|
27.4 Percentage of participants
|
24.0 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any decreased appetite, vaccination 3 (N=924, 460)
|
20.9 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any irritability, vaccination 1
|
63.2 Percentage of participants
|
60.5 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any irritability, vaccination 2 (N=950, 472)
|
56.6 Percentage of participants
|
52.7 Percentage of participants
|
|
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Any irritability, vaccination 3 (N=924, 460)
|
52.7 Percentage of participants
|
48.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after any infant vaccination (up to 6 months)Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up and temperature data.
Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was \>=38.0°C.
Outcome measures
| Measure |
V419
n=981 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=484 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants With Elevated Temperature by Severity
Rectal <38.0°C
|
44.5 Percentage of participants
|
57.7 Percentage of participants
|
|
Percentage of Participants With Elevated Temperature by Severity
Rectal >=38.0°C and <38.5°C, mild
|
24.3 Percentage of participants
|
17.9 Percentage of participants
|
|
Percentage of Participants With Elevated Temperature by Severity
All routes <38.0°C
|
51.1 Percentage of participants
|
64.3 Percentage of participants
|
|
Percentage of Participants With Elevated Temperature by Severity
All routes >=38.0°C and <38.5°C, mild
|
24.2 Percentage of participants
|
19.1 Percentage of participants
|
|
Percentage of Participants With Elevated Temperature by Severity
All routes >=38.5°C and <39.5°C, moderate
|
22.7 Percentage of participants
|
15.5 Percentage of participants
|
|
Percentage of Participants With Elevated Temperature by Severity
All routes >=39.5°C, severe
|
2.0 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With Elevated Temperature by Severity
Rectal >=38.5°C and <39.5°C, moderate
|
21.6 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants With Elevated Temperature by Severity
Rectal >=39.5°C, severe
|
2.0 Percentage of participants
|
0.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 15 days after any infant vaccination (up to 6 months)Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
Outcome measures
| Measure |
V419
n=981 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=484 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Febrile convulsion AEs
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Convulsion AEs
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Pyrexia SAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Pyrexia AEs
|
49.3 Percentage of participants
|
35.6 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Febrile convulsion SAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Convulsion SAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 181 days after any infant vaccination (up to 12 months)Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
Outcome measures
| Measure |
V419
n=981 Participants
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=484 Participants
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Febrile convulsion SAEs
|
0.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Convulsion SAEs
|
0.1 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Pyrexia vaccine-related SAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Pyrexia SAEs
|
0 Percentage of participants
|
0.2 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Febrile convulsion vaccine-related SAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Convulsion vaccine-related SAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
V419
Serious events: 58 serious events
Other events: 939 other events
Deaths: 0 deaths
Control
Serious events: 32 serious events
Other events: 458 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V419
n=980 participants at risk
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=483 participants at risk
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.41%
2/483 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Gastrointestinal disorders
Anal fistula
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.41%
4/980 • Number of events 4 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Device expulsion
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Pyrexia
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Abscess
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Bronchiolitis
|
0.61%
6/980 • Number of events 6 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
1.0%
5/483 • Number of events 5 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Croup infectious
|
0.41%
4/980 • Number of events 5 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.62%
3/483 • Number of events 3 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Gastritis viral
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Gastroenteritis
|
0.51%
5/980 • Number of events 5 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Gastroenteritis viral
|
0.20%
2/980 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Influenza
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Meningitis enteroviral
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Otitis media
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Pneumonia
|
0.51%
5/980 • Number of events 5 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.41%
2/483 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Pyelonephritis
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.61%
6/980 • Number of events 6 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.83%
4/483 • Number of events 4 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Roseola
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Subcutaneous abscess
|
0.20%
2/980 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Upper respiratory tract infection
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Urinary tract infection
|
0.20%
2/980 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Injury, poisoning and procedural complications
Skull fracture base
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Investigations
Urine output decreased
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
12/980 • Number of events 12 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.41%
2/483 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Nervous system disorders
Convulsion
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Nervous system disorders
Dyskinesia
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Nervous system disorders
Dystonia
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Nervous system disorders
Febrile convulsion
|
0.20%
2/980 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Nervous system disorders
Tonic convulsion
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Renal and urinary disorders
Renal failure acute
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
2/980 • Number of events 3 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.10%
1/980 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoeic attack
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.41%
2/483 • Number of events 2 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.10%
1/980 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.00%
0/483 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/980 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
0.21%
1/483 • Number of events 1 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
Other adverse events
| Measure |
V419
n=980 participants at risk
V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
Control
n=483 participants at risk
Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
61/980 • Number of events 68 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
4.6%
22/483 • Number of events 25 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Gastrointestinal disorders
Vomiting
|
28.8%
282/980 • Number of events 432 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
25.9%
125/483 • Number of events 186 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Crying
|
80.4%
788/980 • Number of events 1933 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
76.6%
370/483 • Number of events 857 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Irritability
|
87.0%
853/980 • Number of events 2389 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
85.9%
415/483 • Number of events 1109 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Pyrexia
|
57.1%
560/980 • Number of events 1014 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
44.7%
216/483 • Number of events 356 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Otitis media
|
7.0%
69/980 • Number of events 76 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
5.4%
26/483 • Number of events 28 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
100/980 • Number of events 108 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
8.3%
40/483 • Number of events 41 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Metabolism and nutrition disorders
Decreased appetite
|
58.9%
577/980 • Number of events 1087 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
56.1%
271/483 • Number of events 469 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
Nervous system disorders
Somnolence
|
77.0%
755/980 • Number of events 1863 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
76.4%
369/483 • Number of events 887 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Injection-site bruising
|
6.3%
62/980 • Number of events 103 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
7.5%
36/483 • Number of events 61 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Injection-site erythema
|
60.9%
597/980 • Number of events 2665 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
57.3%
277/483 • Number of events 1365 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Injection-site pain
|
84.3%
826/980 • Number of events 4276 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
81.0%
391/483 • Number of events 2234 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
|
General disorders
Injection-site swelling
|
52.3%
513/980 • Number of events 1974 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
45.3%
219/483 • Number of events 989 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/ presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER