Trial Outcomes & Findings for Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010) (NCT NCT01839188)
NCT ID: NCT01839188
Last Updated: 2019-02-25
Results Overview
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
COMPLETED
PHASE3
385 participants
Month 5 (one month after receiving Vaccination 3)
2019-02-25
Participant Flow
The study enrolled N=385 infant participants previously vaccinated with only 1 dose of monovalent Hepatitis B vaccine, within 3 days after birth, outside of study context.
Participants progressed through the study as a single group, with all participants receiving the same mixed-schedule vaccination series. Vaccination (V1) was administered on Study Day 0 (2 months of age), with V2 (4 months of age) and V3 (6 months of age) administered at Study Months 2 and 4, respectively.
Participant milestones
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|
|
Overall Study
STARTED
|
385
|
|
Overall Study
Treated
|
385
|
|
Overall Study
COMPLETED
|
384
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Includes all participants receiving ≥1 dose of study vaccination, having available data for body weight.
Baseline characteristics by cohort
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
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|---|---|
|
Age, Continuous
|
60.72 Days
STANDARD_DEVIATION 7.75 • n=385 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=385 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=385 Participants
|
|
Body Weight
|
5.14 kg
STANDARD_DEVIATION 0.59 • n=384 Participants • Includes all participants receiving ≥1 dose of study vaccination, having available data for body weight.
|
PRIMARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=369 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
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|---|---|---|---|---|
|
Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL
|
98.9 Percentage of Participants
Interval 97.2 to 99.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=365 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL
|
100.0 Percentage of Participants
Interval 99.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the geometric mean concentration of antibodies to Hepatitis B Surface Antigen (HBsAg). The unit of measure is milli International Units/mL (mIU/mL).
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=369 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)
|
1054.97 mIU/mL
Interval 911.49 to 1221.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
Participant serum samples were collected for analysis by radioimmunoassay (RIA) to determine the geometric mean concentration of antibodies to polyribosylribitol phosphate (PRP), a Haemophilus influenzae type b (Hib) capsular polysaccharide.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=365 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen
|
8.00 μg/mL
Interval 7.17 to 8.93
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean concentration of neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=359 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Antibodies to Diphtheria Toxin
|
0.47 IU/mL
Interval 0.42 to 0.52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
Participant serum samples were collected for analysis by Enzyme-linked Immunosorbent Assay (ELISA) to determine the geometric mean concentration of antibodies to tetanus toxin. The unit of measure is International Units/mL (IU/mL).
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=350 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Antibodies to Tetanus Toxin
|
2.44 IU/mL
Interval 2.31 to 2.59
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
Participant serum samples were collected for analysis by ELISA to determine the geometric mean concentration of antibodies (Abs) to the following Pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae types (FIM) 2\&3. The unit of measure is ELISA Units/mL (EU/mL).
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=349 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations of Antibodies to Pertussis Antigens
Anti-PT Abs
|
107.46 EU/mL
Interval 101.55 to 113.71
|
—
|
—
|
—
|
|
Geometric Mean Concentrations of Antibodies to Pertussis Antigens
Anti-FHA Abs
|
67.09 EU/mL
Interval 62.38 to 72.15
|
—
|
—
|
—
|
|
Geometric Mean Concentrations of Antibodies to Pertussis Antigens
Anti-PRN Abs
|
56.46 EU/mL
Interval 51.6 to 61.78
|
—
|
—
|
—
|
|
Geometric Mean Concentrations of Antibodies to Pertussis Antigens
Anti-FIM 2&3 Abs
|
360.99 EU/mL
Interval 332.58 to 391.82
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean titer of neutralizing antibodies (Abs) to Inactivated Poliovirus 1, 2, \& 3 (IPV1, IPV2, \& IPV3). The unit of measure is titer, expressed as the reciprocal dilution of the highest dilution that neutralizes 50% of the challenge virus.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=356 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)
Anti-IPV1 Abs
|
663.97 Titer
Interval 588.1 to 749.62
|
—
|
—
|
—
|
|
Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)
Anti-IPV2 Abs
|
1198.93 Titer
Interval 1051.9 to 1366.51
|
—
|
—
|
—
|
|
Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)
Anti-IPV3 Abs
|
764.64 Titer
Interval 664.7 to 879.61
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 5 (one month after receiving Vaccination 3)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
Participants were considered as responding if the observed concentration or titer for antibodies (Abs) to specific antigens exceeded the following thresholds: 1. For anti-PRP Abs (Hib capsular polysaccharide) - Response defined as a concentration ≥1 µg/mL (measured by RIA); 2. For anti-D Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by MIT); 3. For anti-T Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by ELISA); 4. For anti-IPV1, anti-IPV2, and anti-IPV3 Abs - Response defined as a titer ≥ 8 (measured by MIT). The percentage of participants considered as responding to the individual antigen (per the response threshold\[s\]) were assessed.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=370 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Anti-PRP Ab ≥ 1 μg/mL
|
95.3 Percentage of Participants
Interval 92.6 to 97.3
|
—
|
—
|
—
|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Anti-Diptheria Ab ≥0.01 IU/mL
|
100.0 Percentage of Participants
Interval 99.0 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Anti-Diptheria Ab ≥0.10 IU/mL
|
92.2 Percentage of Participants
Interval 88.9 to 94.8
|
—
|
—
|
—
|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Anti-Tetanus ≥0.01 IU/mL
|
100.0 Percentage of Participants
Interval 99.0 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Anti-Tetanus Ab ≥0.10 IU/mL
|
100.0 Percentage of Participants
Interval 99.0 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Anti-IPV1 Ab Titer ≥8
|
100.0 Percentage of Participants
Interval 99.0 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Anti-IPV2 Ab Titer ≥8
|
100.0 Percentage of Participants
Interval 99.0 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Anti-IPV3 Ab Titer ≥8
|
100.0 Percentage of Participants
Interval 99.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 (one month after receiving Vaccination 2)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
Participant serum samples were collected to determine the geometric mean titer of anti-MCC antibodies, measured by the Serum Bactericidal Antibody assay using rabbit complement (rSBA). The unit of measure is titer, expressed as the reciprocal of the final serum dilution giving ≥50% killing of the challenge bacterial strain.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=375 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies
|
739.63 Titer
Interval 659.94 to 828.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 (one month after receiving Vaccination 2)Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
The percentage of participants with an anti-MCC antibody titer ≥8 was assessed. Participant serum samples were collected and analyzed for anti-MCC antibodies with the Serum Bactericidal Antibody assay using rabbit complement (rSBA).
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=375 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8
|
99.2 Percentage of Participants
Interval 97.7 to 99.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 5 following each vaccinationPopulation: All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data, having available body temperature data.
The percentage of participants with a body temperature ≥38.0°C from Day 1 to Day 5 after each vaccination was assessed. Per protocol, the participant's parent(s)/legal representative recorded daily body temperature measurements each evening by the axillary route (N=3 collected via rectal route; N=1 collected via oral route) and recorded these observations on the Vaccine Report Card (VRC). Temperatures were based on actual temperatures recorded with no adjustments for the route of assessment.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=384 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
n=383 Participants
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
n=383 Participants
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination
|
4.9 Percentage of Participants
|
6.3 Percentage of Participants
|
4.7 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 5 following each vaccinationPopulation: All participants receiving ≥1 dose of PR5I/Pediacel® vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm) with PR5I/Pediacel®.
The number of participants experiencing solicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each vaccination and after any vaccination.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
n=385 Participants
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
n=384 Participants
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site erythema
|
81 Participants
|
65 Participants
|
69 Participants
|
136 Participants
|
|
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site pain
|
152 Participants
|
97 Participants
|
93 Participants
|
200 Participants
|
|
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site swelling
|
68 Participants
|
52 Participants
|
65 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5 following each vaccinationPopulation: All participants receiving ≥1 dose of NeisVac-C® vaccination with corresponding safety follow-up data after each vaccination (for V1 and V2 arms) and after any vaccination (for V1; V2 arm) with NeisVac-C®.
The number of participants experiencing solicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
n=385 Participants
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
n=385 Participants
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
Injection-site swelling
|
34 Participants
|
42 Participants
|
66 Participants
|
—
|
|
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
Injection-site erythema
|
41 Participants
|
59 Participants
|
85 Participants
|
—
|
|
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
Injection-site pain
|
113 Participants
|
89 Participants
|
151 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 15 following each vaccinationPopulation: All participants receiving ≥1 dose of PR5I/Pediacel® vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm) with PR5I/Pediacel®.
The number of participants experiencing unsolicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Unsolicited ISRs occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each vaccination and after any vaccination.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
n=385 Participants
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
n=384 Participants
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site haemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site induration
|
5 Participants
|
4 Participants
|
8 Participants
|
16 Participants
|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site warmth
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site bruising
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site discomfort
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
Injection-site haematoma
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Day 15 following each vaccinationPopulation: All participants receiving ≥1 dose of NeisVac-C® vaccination with corresponding safety follow-up data after each vaccination (for V1 and V2 arms) and after any vaccination (for V1; V2 arm) with NeisVac-C®.
The number of participants experiencing unsolicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Unsolicited ISRs occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
n=385 Participants
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
n=385 Participants
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
Injection-site haematoma
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
Injection-site induration
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
Injection-site discolouration
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 5 following each vaccinationPopulation: All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm).
The number of participants experiencing solicited systemic AEs (crying, decreased appetite, irritability, somnolence, pyrexia, and vomiting) was assessed. Each day from Day 1 to Day 5 following each vaccination, the participant's parent(s)/legal representative recorded all solicited AEs on the VRC. Data are presented for the number of participants experiencing solicited AEs up to Day 5 after each vaccination and after any vaccination.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
n=385 Participants
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
n=384 Participants
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
Crying
|
188 Participants
|
131 Participants
|
102 Participants
|
255 Participants
|
|
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
Decreased appetite
|
141 Participants
|
88 Participants
|
76 Participants
|
195 Participants
|
|
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
Irritability
|
196 Participants
|
154 Participants
|
119 Participants
|
268 Participants
|
|
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
Pyrexia
|
19 Participants
|
24 Participants
|
18 Participants
|
52 Participants
|
|
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
Somnolence
|
184 Participants
|
126 Participants
|
84 Participants
|
229 Participants
|
|
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
Vomiting
|
56 Participants
|
35 Participants
|
27 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: Up to Day 15 following each vaccinationPopulation: All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm).
The number of participants experiencing unsolicited systemic AEs was assessed. Data are presented for the number of participants experiencing unsolicited AEs up to Day 15 after each vaccination and after any vaccination.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
n=385 Participants
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
n=384 Participants
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|---|---|---|
|
Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE)
|
58 Participants
|
53 Participants
|
89 Participants
|
163 Participants
|
SECONDARY outcome
Timeframe: Up to ~6 months (at any time during the study)Population: All participants receiving ≥1 dose of study vaccination.
An SAE is an adverse event (AE) that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention.
Outcome measures
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 Participants
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
Pediacel® (V2)
\[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age.
|
PR5I (V3)
\[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
PR5I (V1); Pediacel® (V2); PR5I (V3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
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|---|---|---|---|---|
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Number of Participants Experiencing a Serious Adverse Event (SAE)
|
12 Participants
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—
|
—
|
—
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Adverse Events
PR5I (V1); Pediacel® (V2); PR5I (V3)
Serious adverse events
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 participants at risk
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
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|---|---|
|
Infections and infestations
Bronchiolitis
|
1.3%
5/385 • Number of events 5 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Infections and infestations
Periorbital cellulitis
|
0.26%
1/385 • Number of events 1 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Infections and infestations
Sepsis
|
0.26%
1/385 • Number of events 1 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
1/385 • Number of events 1 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.26%
1/385 • Number of events 1 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.26%
1/385 • Number of events 1 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.26%
1/385 • Number of events 1 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.26%
1/385 • Number of events 1 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
Other adverse events
| Measure |
PR5I (V1); Pediacel® (V2); PR5I (V3)
n=385 participants at risk
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
2.9%
11/385 • Number of events 12 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
15/385 • Number of events 17 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
24.2%
93/385 • Number of events 136 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
General disorders
Crying
|
66.2%
255/385 • Number of events 452 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
General disorders
Injection site erythema
|
39.5%
152/385 • Number of events 316 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
General disorders
Injection site induration
|
4.9%
19/385 • Number of events 21 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
General disorders
Injection site pain
|
54.0%
208/385 • Number of events 544 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
General disorders
Injection site swelling
|
33.8%
130/385 • Number of events 261 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
General disorders
Pyrexia
|
14.5%
56/385 • Number of events 69 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Infections and infestations
Bronchiolitis
|
4.2%
16/385 • Number of events 16 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Infections and infestations
Conjunctivitis
|
2.9%
11/385 • Number of events 11 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
21/385 • Number of events 23 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Infections and infestations
Respiratory tract infection
|
3.1%
12/385 • Number of events 13 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
8/385 • Number of events 9 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.9%
196/385 • Number of events 319 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Nervous system disorders
Somnolence
|
59.5%
229/385 • Number of events 414 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Psychiatric disorders
Irritability
|
69.6%
268/385 • Number of events 499 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
2.3%
9/385 • Number of events 12 • Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Subsequent to public disclosure of study results, an investigator and colleagues participating in a multicenter study may publish data collected in their center independently. In such case the Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations based on these study results 60 calendar days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential will be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER