Trial Outcomes & Findings for Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068) (NCT NCT00289913)
NCT ID: NCT00289913
Last Updated: 2017-04-13
Results Overview
SPR is the percent of participants with Hepatitis A antibody titers \>= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1274 participants
Primary outcome timeframe
4 weeks after dose 2 of VAQTA™
Results posted on
2017-04-13
Participant Flow
In Stage I, a total of 620 participants were randomized to receive study vaccinations. However for 3 participants, the Health Insurance Portability and Accountability Act (HIPAA) and/or Informed Consent Form was not signed by the parents in error. Therefore a total of 617 participants were included in Stage I. 654 participants started Stage II.
For this study: Visit 1 was on Day 1 (for Stage I and Stage II). Visit 2 was at Week 4 (Stage I) and Week 2 (Stage II). Visit 3 was at Week 24/Week 28 (Stage I) and Week 24 (Stage II). Visit 4 was at Week 28/Week 32 (Stage I) and Week 26 (Stage II). For safety, participants were followed for 14 days after each vaccination (safety follow-up \[F/U\]).
Participant milestones
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
|---|---|---|---|---|---|
|
Visit 1 (Stage I and Stage II)
STARTED
|
155
|
151
|
159
|
152
|
654
|
|
Visit 1 (Stage I and Stage II)
COMPLETED
|
146
|
135
|
150
|
141
|
645
|
|
Visit 1 (Stage I and Stage II)
NOT COMPLETED
|
9
|
16
|
9
|
11
|
9
|
|
Visit 2 (Stage I and Stage II)
STARTED
|
146
|
135
|
150
|
141
|
645
|
|
Visit 2 (Stage I and Stage II)
COMPLETED
|
131
|
114
|
140
|
135
|
605
|
|
Visit 2 (Stage I and Stage II)
NOT COMPLETED
|
15
|
21
|
10
|
6
|
40
|
|
Visit 3 (Stage I and Stage II)
STARTED
|
131
|
114
|
140
|
135
|
605
|
|
Visit 3 (Stage I and Stage II)
COMPLETED
|
122
|
106
|
138
|
131
|
597
|
|
Visit 3 (Stage I and Stage II)
NOT COMPLETED
|
9
|
8
|
2
|
4
|
8
|
|
Visit 4 (Stage I and Stage II)
STARTED
|
122
|
106
|
138
|
131
|
597
|
|
Visit 4 (Stage I and Stage II)
COMPLETED
|
122
|
106
|
138
|
131
|
597
|
|
Visit 4 (Stage I and Stage II)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
|---|---|---|---|---|---|
|
Visit 1 (Stage I and Stage II)
Protocol deviation during safety F/U
|
0
|
1
|
0
|
0
|
0
|
|
Visit 1 (Stage I and Stage II)
Lost during safety F/U
|
3
|
2
|
2
|
2
|
1
|
|
Visit 1 (Stage I and Stage II)
Withdrew consent during safety F/U
|
2
|
2
|
0
|
2
|
2
|
|
Visit 1 (Stage I and Stage II)
Moved during safety F/U
|
0
|
0
|
0
|
0
|
1
|
|
Visit 1 (Stage I and Stage II)
Other reasons during safety F/U
|
0
|
0
|
0
|
1
|
0
|
|
Visit 1 (Stage I and Stage II)
Protocol deviation after safety F/U
|
1
|
2
|
0
|
0
|
0
|
|
Visit 1 (Stage I and Stage II)
Lost after safety F/U
|
2
|
1
|
0
|
0
|
5
|
|
Visit 1 (Stage I and Stage II)
Withdrew consent after safety F/U]
|
0
|
8
|
5
|
6
|
0
|
|
Visit 1 (Stage I and Stage II)
Other reasons after safety F/U
|
1
|
0
|
2
|
0
|
0
|
|
Visit 2 (Stage I and Stage II)
Protocol deviation during safety F/U
|
0
|
0
|
1
|
0
|
0
|
|
Visit 2 (Stage I and Stage II)
Lost during safety F/U
|
8
|
11
|
2
|
2
|
0
|
|
Visit 2 (Stage I and Stage II)
Subject moved during safety F/U
|
0
|
1
|
0
|
0
|
0
|
|
Visit 2 (Stage I and Stage II)
Withdrew consent during safety F/U
|
3
|
2
|
1
|
0
|
0
|
|
Visit 2 (Stage I and Stage II)
Other reasons during safety F/U
|
1
|
0
|
1
|
0
|
0
|
|
Visit 2 (Stage I and Stage II)
Protocol deviation after safety F/U
|
0
|
1
|
3
|
1
|
0
|
|
Visit 2 (Stage I and Stage II)
Lost after safety F/U
|
2
|
5
|
0
|
3
|
0
|
|
Visit 2 (Stage I and Stage II)
Withdrew consent after safety F/U
|
0
|
1
|
2
|
0
|
0
|
|
Visit 2 (Stage I and Stage II)
Other reasons after safety F/U]
|
1
|
0
|
0
|
0
|
0
|
|
Visit 2 (Stage I and Stage II)
Protocol deviation (Stage II)
|
0
|
0
|
0
|
0
|
7
|
|
Visit 2 (Stage I and Stage II)
Lost (Stage II)
|
0
|
0
|
0
|
0
|
11
|
|
Visit 2 (Stage I and Stage II)
Moved (Stage II)
|
0
|
0
|
0
|
0
|
6
|
|
Visit 2 (Stage I and Stage II)
Withdrew consent (Stage II)
|
0
|
0
|
0
|
0
|
7
|
|
Visit 2 (Stage I and Stage II)
Other reasons (Stage II)
|
0
|
0
|
0
|
0
|
9
|
|
Visit 3 (Stage I and Stage II)
Protocol deviation during safety F/U
|
0
|
1
|
0
|
0
|
0
|
|
Visit 3 (Stage I and Stage II)
Lost during safety F/U
|
8
|
3
|
1
|
2
|
2
|
|
Visit 3 (Stage I and Stage II)
Withdrew consent during safety F/U
|
0
|
0
|
0
|
1
|
0
|
|
Visit 3 (Stage I and Stage II)
Other reasons during safety F/U
|
0
|
0
|
0
|
0
|
1
|
|
Visit 3 (Stage I and Stage II)
Lost after safety F/U
|
1
|
2
|
0
|
1
|
4
|
|
Visit 3 (Stage I and Stage II)
Withdrew consent after safety F/U]
|
0
|
1
|
1
|
0
|
0
|
|
Visit 3 (Stage I and Stage II)
Moved after safety F/U
|
0
|
0
|
0
|
0
|
1
|
|
Visit 3 (Stage I and Stage II)
Other reasons after safety F/U
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
Baseline characteristics by cohort
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
n=155 Participants
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
n=151 Participants
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
n=159 Participants
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)
n=152 Participants
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
n=654 Participants
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
Total
n=1271 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Between 12 and 18 months
|
155 participants
n=99 Participants
|
151 participants
n=107 Participants
|
159 participants
n=206 Participants
|
152 participants
n=7 Participants
|
654 participants
n=31 Participants
|
1271 participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
73 Participants
n=7 Participants
|
319 Participants
n=31 Participants
|
603 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
79 Participants
n=7 Participants
|
335 Participants
n=31 Participants
|
668 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after dose 2 of VAQTA™Population: The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.
SPR is the percent of participants with Hepatitis A antibody titers \>= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).
Outcome measures
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
n=94 Participants
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
n=78 Participants
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
n=114 Participants
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)
n=105 Participants
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
|---|---|---|---|---|---|
|
Seropositivity Rate (SPR) to Hepatitis A
|
100 Percentage of participants
Interval 96.2 to 100.0
|
100 Percentage of participants
Interval 95.4 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
100 Percentage of participants
Interval 96.5 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 4 weeks postvaccination with PedvaxHIB™Population: The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.
Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate \[PRP\]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL. The antibody response rate is defined as the percentage of participants with anti-PRP titers \>1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™.
Outcome measures
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
n=106 Participants
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
n=99 Participants
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
n=110 Participants
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)
n=109 Participants
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
|---|---|---|---|---|---|
|
Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
|
98.1 Percentage of participants
Interval 93.4 to 99.8
|
97.0 Percentage of participants
Interval 91.4 to 99.4
|
97.3 Percentage of participants
Interval 92.2 to 99.4
|
97.2 Percentage of participants
Interval 92.2 to 99.4
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEsPopulation: Participants administered at least one dose of vaccine, for whom follow-up was available.
Systemic and injection site AEs were collected from participants receiving * VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I) * VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I) * VAQTA™ administered alone (Stage II) Safety data was collected on a standardized Vaccination Report Card (VRC) following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE.
Outcome measures
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
n=302 Participants
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
n=256 Participants
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
n=647 Participants
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE)
With one or more AE
|
239 Participants
|
170 Participants
|
466 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
---sytemic AE
|
183 Participants
|
119 Participants
|
395 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
---injection-site AE (VR)
|
164 Participants
|
116 Participants
|
249 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
With serious AE (VR)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Who died
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Who discontinued due to serious AE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
With no AE
|
63 Participants
|
86 Participants
|
181 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
---injection-site AE
|
167 Participants
|
116 Participants
|
249 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
With vaccine-related (VR) AE
|
192 Participants
|
129 Participants
|
328 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
---sytemic AE (VR)
|
91 Participants
|
42 Participants
|
147 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
With serious AE
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Who discontinued due to AE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks postvaccination with Infanrix™Population: The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.
GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™. IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL. IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL. IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL.
Outcome measures
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
n=85 Participants
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
n=83 Participants
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
PRN
|
333.5 ELISA units per mL (ELU/mL)
Interval 267.3 to 416.1
|
358.5 ELISA units per mL (ELU/mL)
Interval 282.7 to 454.7
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
Pertussis PT
|
69.2 ELISA units per mL (ELU/mL)
Interval 57.4 to 83.5
|
51.7 ELISA units per mL (ELU/mL)
Interval 41.5 to 64.5
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
Pertussis FHA
|
253.8 ELISA units per mL (ELU/mL)
Interval 215.3 to 299.2
|
249.2 ELISA units per mL (ELU/mL)
Interval 200.6 to 309.5
|
—
|
—
|
—
|
Adverse Events
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
Serious events: 0 serious events
Other events: 116 other events
Deaths: 0 deaths
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
Serious events: 2 serious events
Other events: 74 other events
Deaths: 0 deaths
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
Serious events: 0 serious events
Other events: 123 other events
Deaths: 0 deaths
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I)
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
VAQTA™/ VAQTA™ (Stage 2)
Serious events: 2 serious events
Other events: 426 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
n=150 participants at risk
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
n=145 participants at risk
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
n=152 participants at risk
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I)
n=146 participants at risk
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
n=641 participants at risk
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.00%
0/150
|
0.00%
0/145
|
0.00%
0/152
|
0.00%
0/146
|
0.16%
1/641 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/150
|
0.00%
0/145
|
0.00%
0/152
|
0.68%
1/146 • Number of events 1
|
0.00%
0/641
|
|
General disorders
PYREXIA
|
0.00%
0/150
|
0.00%
0/145
|
0.00%
0/152
|
0.68%
1/146 • Number of events 1
|
0.00%
0/641
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/150
|
0.00%
0/145
|
0.00%
0/152
|
0.68%
1/146 • Number of events 1
|
0.00%
0/641
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/150
|
0.00%
0/145
|
0.00%
0/152
|
0.68%
1/146 • Number of events 1
|
0.00%
0/641
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/150
|
0.69%
1/145 • Number of events 1
|
0.00%
0/152
|
0.00%
0/146
|
0.00%
0/641
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
0.00%
0/150
|
0.00%
0/145
|
0.00%
0/152
|
0.00%
0/146
|
0.16%
1/641 • Number of events 1
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/150
|
0.00%
0/145
|
0.00%
0/152
|
0.68%
1/146 • Number of events 1
|
0.00%
0/641
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/150
|
0.69%
1/145 • Number of events 1
|
0.00%
0/152
|
0.00%
0/146
|
0.00%
0/641
|
Other adverse events
| Measure |
VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)
n=150 participants at risk
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)
n=145 participants at risk
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)
n=152 participants at risk
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
|
PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I)
n=146 participants at risk
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
|
VAQTA™/ VAQTA™ (Stage 2)
n=641 participants at risk
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
14.0%
21/150 • Number of events 23
|
5.5%
8/145 • Number of events 10
|
10.5%
16/152 • Number of events 17
|
5.5%
8/146 • Number of events 10
|
7.8%
50/641 • Number of events 54
|
|
Gastrointestinal disorders
TEETHING
|
2.0%
3/150 • Number of events 3
|
2.1%
3/145 • Number of events 4
|
5.3%
8/152 • Number of events 8
|
6.2%
9/146 • Number of events 9
|
8.7%
56/641 • Number of events 69
|
|
Gastrointestinal disorders
VOMITING
|
4.7%
7/150 • Number of events 7
|
2.8%
4/145 • Number of events 4
|
6.6%
10/152 • Number of events 11
|
5.5%
8/146 • Number of events 8
|
4.2%
27/641 • Number of events 31
|
|
General disorders
INJECTION SITE ERYTHEMA
|
32.0%
48/150 • Number of events 62
|
20.7%
30/145 • Number of events 39
|
27.6%
42/152 • Number of events 55
|
29.5%
43/146 • Number of events 58
|
21.7%
139/641 • Number of events 174
|
|
General disorders
INJECTION SITE PAIN
|
50.0%
75/150 • Number of events 98
|
27.6%
40/145 • Number of events 54
|
40.8%
62/152 • Number of events 83
|
37.7%
55/146 • Number of events 71
|
31.7%
203/641 • Number of events 264
|
|
General disorders
INJECTION SITE SWELLING
|
24.0%
36/150 • Number of events 42
|
10.3%
15/145 • Number of events 19
|
17.1%
26/152 • Number of events 30
|
17.8%
26/146 • Number of events 30
|
11.4%
73/641 • Number of events 88
|
|
General disorders
IRRITABILITY
|
18.7%
28/150 • Number of events 35
|
9.0%
13/145 • Number of events 13
|
8.6%
13/152 • Number of events 13
|
7.5%
11/146 • Number of events 14
|
12.3%
79/641 • Number of events 102
|
|
General disorders
PYREXIA
|
28.7%
43/150 • Number of events 58
|
16.6%
24/145 • Number of events 28
|
27.6%
42/152 • Number of events 47
|
15.8%
23/146 • Number of events 24
|
16.5%
106/641 • Number of events 123
|
|
Infections and infestations
NASOPHARYNGITIS
|
14.0%
21/150 • Number of events 22
|
5.5%
8/145 • Number of events 8
|
4.6%
7/152 • Number of events 9
|
2.7%
4/146 • Number of events 4
|
3.0%
19/641 • Number of events 19
|
|
Infections and infestations
OTITIS MEDIA
|
6.0%
9/150 • Number of events 9
|
2.8%
4/145 • Number of events 5
|
12.5%
19/152 • Number of events 19
|
6.2%
9/146 • Number of events 10
|
5.9%
38/641 • Number of events 39
|
|
Infections and infestations
RHINITIS
|
7.3%
11/150 • Number of events 13
|
0.69%
1/145 • Number of events 2
|
3.3%
5/152 • Number of events 5
|
0.00%
0/146
|
1.6%
10/641 • Number of events 12
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.0%
9/150 • Number of events 9
|
3.4%
5/145 • Number of events 6
|
15.1%
23/152 • Number of events 25
|
5.5%
8/146 • Number of events 10
|
10.1%
65/641 • Number of events 69
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.7%
13/150 • Number of events 16
|
2.1%
3/145 • Number of events 3
|
7.9%
12/152 • Number of events 12
|
4.1%
6/146 • Number of events 6
|
7.5%
48/641 • Number of events 50
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
7.3%
11/150 • Number of events 13
|
3.4%
5/145 • Number of events 5
|
8.6%
13/152 • Number of events 14
|
4.1%
6/146 • Number of events 10
|
8.9%
57/641 • Number of events 65
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp.
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. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER