Trial Outcomes & Findings for Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants (NCT NCT00831311)
NCT ID: NCT00831311
Last Updated: 2013-12-17
Results Overview
Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
624 participants
Primary outcome timeframe
1 month post last vaccination
Results posted on
2013-12-17
Participant Flow
Participants were enrolled and treated from 26 October 2004 to 10 November 2005 in 1 clinical center in Argentina.
A total of 624 participants who met the inclusion but no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Overall Study
STARTED
|
312
|
312
|
|
Overall Study
COMPLETED
|
300
|
304
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Overall Study
Definitive Contraindication
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
Baseline Characteristics
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Baseline characteristics by cohort
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=312 Participants
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=312 Participants
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
Total
n=624 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
312 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
624 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
1.76 Months
STANDARD_DEVIATION 0.12 • n=5 Participants
|
1.77 Months
STANDARD_DEVIATION 0.11 • n=7 Participants
|
1.76 Months
STANDARD_DEVIATION 0.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
312 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
624 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month post last vaccinationPopulation: Seroconversion for anti-pertussis toxoid and anti-filamentous hemagglutinin antibodies was assessed in the per-protocol population.
Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Outcome measures
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=260 Participants
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=271 Participants
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Pertussis toxoid (N = 233, 241)
|
92 Percentage of Participants
|
93 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Filamentous hemagglutinin (N = 250, 249)
|
93 Percentage of Participants
|
90 Percentage of Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 150 (1 month post-vaccination 3)Population: Seroprotection to the vaccine antigens was assessed in the per-protocol population.
Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.
Outcome measures
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=260 Participants
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=271 Participants
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Hepatitis B (N = 258, 271)
|
99 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-PRP (N = 260, 270)
|
95 Percentage of Participants
|
97 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Tetanus (N = 260, 271)
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Diphtheria (N = 260, 271)
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 1 (N = 259, 268)
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 2 (N = 257, 269)
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 3 (N = 257, 263)
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 150 (1 month post-vaccination 3)Population: Geometric mean titers to the vaccine antigens were assessed in the per-protocol population.
Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).
Outcome measures
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=260 Participants
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=271 Participants
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Day 0 (N = 256, 267)
|
1.14 Titers
Interval 0.96 to 1.36
|
1.16 Titers
Interval 0.989 to 1.37
|
|
Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Day 150 (N = 260, 271)
|
2.29 Titers
Interval 2.09 to 2.51
|
1.79 Titers
Interval 1.66 to 1.92
|
PRIMARY outcome
Timeframe: Day 150 (1 month post-vaccination 3)Population: Geometric mean titers to the Polio Antigens were assessed in the per-protocol population.
Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).
Outcome measures
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=260 Participants
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=271 Participants
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 1 Day 0 (N = 250, 258)
|
7.41 Titers
Interval 6.34 to 8.65
|
7.04 Titers
Interval 6.08 to 8.15
|
|
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 1 Day 150 (N = 259, 268)
|
4091 Titers
Interval 3452.0 to 4848.0
|
4198 Titers
Interval 3595.0 to 4901.0
|
|
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 2 Day 0 (N = 249, 261)
|
11.5 Titers
Interval 9.72 to 13.7
|
10.5 Titers
Interval 9.02 to 12.1
|
|
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 2 Day 150 (N = 257, 269)
|
3244 Titers
Interval 2757.0 to 3817.0
|
3223 Titers
Interval 2753.0 to 3773.0
|
|
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 3 Day 0 (N = 246, 254)
|
6.89 Titers
Interval 6.09 to 7.81
|
6.77 Titers
Interval 6.04 to 7.6
|
|
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Anti-Polio Type 3 Day 150 (N = 257, 263)
|
3839 Titers
Interval 3197.0 to 4610.0
|
5502 Titers
Interval 4608.0 to 6570.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Safety was assessed on the safety analysis (intent-to- treat) population.
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP\~T and PENTAXIM™ injection sites
Outcome measures
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=311 Participants
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=312 Participants
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Erythema Post-vaccination 1
|
120 Participants
|
89 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Erythema (≥ 5 cm) Post-vaccination 1
|
6 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Erythema Post-vaccination 2
|
138 Participants
|
107 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Erythema (≥ 5 cm) Post-vaccination 2
|
6 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Erythema Post-vaccination 3
|
143 Participants
|
115 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Erythema (≥ 5 cm) Post-vaccination 3
|
7 Participants
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Edema Post-vaccination 1
|
97 Participants
|
62 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Edema (≥ 5 cm) Post-vaccination 1
|
10 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Edema Post-vaccination 2
|
88 Participants
|
72 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Edema (≥ 5 cm) Post-vaccination 2
|
4 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Edema Post-vaccination 3
|
100 Participants
|
73 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Edema (≥ 5 cm) Post-vaccination 3
|
3 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Induration Post-vaccination 1
|
140 Participants
|
100 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Induration (≥ 5 cm) Post-vaccination 1
|
6 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Induration Post-vaccination 2
|
123 Participants
|
99 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Induration (≥ 5 cm) Post-vaccination 2
|
3 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Induration Post-vaccination 3
|
125 Participants
|
106 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Induration (≥ 5 cm) Post-vaccination 3
|
2 Participants
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Pain Post-vaccination 1
|
195 Participants
|
138 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Pain (Cries when moved) Post-vaccination 1
|
83 Participants
|
34 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Pain Post-vaccination 2
|
139 Participants
|
115 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Pain (Cries when moved) Post-vaccination 2
|
36 Participants
|
13 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Any Injection site Pain Post-vaccination 3
|
126 Participants
|
105 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Grade 3 Pain (Cries when moved) Post-vaccination 3
|
15 Participants
|
8 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Safety was assessed on the safety analysis (intend-to-treat) population.
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP\~T and ENGERIX B® injection sites.
Outcome measures
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=311 Participants
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=312 Participants
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Pain (Cries when moved) Post-vaccination 3
|
15 Participants
|
6 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Erythema Post-vaccination 1
|
120 Participants
|
59 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Erythema (≥5 cm) Post-vaccination 1
|
6 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Erythema Post-vaccination 2
|
138 Participants
|
56 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Erythema (≥5 cm) Post-vaccination 2
|
6 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Erythema Post-vaccination 3
|
143 Participants
|
67 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Erythema (≥5 cm) Post-vaccination 3
|
7 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Edema Post-vaccination 1
|
97 Participants
|
43 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Edema (≥ 5 cm) Post-vaccination 1
|
10 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Edema Post-vaccination 2
|
88 Participants
|
37 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Edema (≥5 cm) Post-vaccination 2
|
4 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Edema Post-vaccination 3
|
100 Participants
|
42 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Edema (≥ 5 cm) Post-vaccination 3
|
3 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Induration Post-vaccination 1
|
140 Participants
|
45 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Induration (≥ 5 cm) Post-vaccination 1
|
6 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Induration Post-vaccination 2
|
123 Participants
|
41 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Induration (≥ 5 cm) Post-vaccination 2
|
3 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Induration Post-vaccination 3
|
125 Participants
|
51 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Induration (≥5 cm) Post-vaccination 3
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Pain Post-vaccination 1
|
195 Participants
|
123 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Pain (Cries when moved) Post-vaccination 1
|
83 Participants
|
26 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Pain Post-vaccination 2
|
139 Participants
|
88 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Grade 3 Pain (Cries when moved) Post-vaccination 2
|
36 Participants
|
11 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Any Injection site Pain Post-vaccination 3
|
126 Participants
|
84 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Safety was assessed on the safety analysis (intent-to- treat) population.
Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination. Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry.
Outcome measures
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=311 Participants
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=312 Participants
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Irritability Post-vaccination 2 (N = 302, 307)
|
129 Participants
|
112 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Irritability Post-vaccination 2; N=302,307
|
13 Participants
|
7 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Irritability Post-vaccination 3 (N = 300, 304)
|
115 Participants
|
97 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Irritability Post-vaccination 3; N=300,304
|
11 Participants
|
6 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Anorexia Post-vaccination 1 (N = 311, 312)
|
78 Participants
|
72 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Anorexia Post-vaccination 1 (N = 311, 312)
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Anorexia Post-vaccination 2 (N = 302, 307)
|
68 Participants
|
52 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Anorexia Post-vaccination 2 (N = 302, 307)
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Anorexia Post-vaccination 3 (N = 300, 304)
|
80 Participants
|
53 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Anorexia Post-vaccination 3 (N = 300, 304)
|
12 Participants
|
2 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Pyrexia Post-vaccination 1 (N = 311, 312)
|
116 Participants
|
71 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Pyrexia Post-vaccination 1 (N = 311, 312)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Pyrexia Post-vaccination 2 (N = 302, 307)
|
95 Participants
|
84 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Pyrexia Post-vaccination 2 (N = 302, 307)
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Pyrexia Post-vaccination 3 (N = 300, 304)
|
99 Participants
|
83 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Pyrexia Post-vaccination 3 (N = 300, 304)
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Somnolence Post-vaccination 1 (N = 311, 312)
|
143 Participants
|
109 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Somnolence Post-vaccination 1 (N=311, 312)
|
63 Participants
|
48 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Somnolence Post-vaccination 2 (N = 302, 307)
|
87 Participants
|
73 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Somnolence Post-vaccination 2 (N=302, 307)
|
18 Participants
|
13 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Somnolence Post-vaccination 3 (N = 300, 304)
|
85 Participants
|
65 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Somnolence Post-vaccination 3 (N=300, 304)
|
22 Participants
|
14 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Irritability Post-vaccination 1 (N = 311, 312)
|
161 Participants
|
134 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Irritability Post-vaccination 1; N=311,312
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Vomiting NOS Post-vaccination 1 (N = 311, 312)
|
56 Participants
|
61 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Vomiting NOS Post-vaccination 1: N=311,312
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Vomiting NOS Post-vaccination 2 (N = 302, 307)
|
34 Participants
|
41 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Vomiting NOS Post-vaccination 2: N=302,307
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Vomiting NOS Post-vaccination 3 (N = 300, 304)
|
42 Participants
|
23 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Vomiting NOS Post-vaccination 3: N=300,304
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Diarrhea NOS Post-vaccination 1 (N = 311, 312)
|
68 Participants
|
60 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Diarrhea NOS Post-vaccination 1: N=311,312
|
10 Participants
|
6 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Diarrhea NOS Post-vaccination 2 (N = 302, 307)
|
51 Participants
|
43 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Diarrhea NOS Post-vaccination 2: N=302,307
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Diarrhea NOS Post-vaccination 3 (N = 300, 304)
|
33 Participants
|
31 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Diarrhea NOS Post-vaccination 3: N=300,304
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Crying Post-vaccination 1 (N = 311, 312)
|
152 Participants
|
113 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Crying Post-vaccination 1 (N = 311, 312)
|
9 Participants
|
1 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Crying Post-vaccination 2 (N = 302, 307)
|
104 Participants
|
89 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Crying Post-vaccination 2 (N = 302, 307)
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Any Crying Post-vaccination 3 (N = 300, 304)
|
78 Participants
|
71 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Grade 3 Crying Post-vaccination 3 (N = 300, 304)
|
2 Participants
|
1 Participants
|
Adverse Events
Group 1: DTaP-IPV-Hep B-PRP~T
Serious events: 19 serious events
Other events: 305 other events
Deaths: 0 deaths
Group 2: PENTAXIM™ and ENGERIX B®
Serious events: 22 serious events
Other events: 307 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=311 participants at risk
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=312 participants at risk
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
General disorders
Pyrexia
|
0.32%
1/311 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.32%
1/312 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Infections and infestations
Bronchiolitis
|
2.9%
9/311 • Number of events 9 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
1.9%
6/312 • Number of events 6 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/311 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.96%
3/312 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.96%
3/311 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.96%
3/312 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Infections and infestations
Pneumonia
|
1.3%
4/311 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.96%
3/312 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/311 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.32%
1/312 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/311 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.96%
3/312 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.32%
1/311 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.32%
1/312 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.32%
1/311 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.00%
0/312 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/311 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.64%
2/312 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Nervous system disorders
Encephalitis
|
0.32%
1/311 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.00%
0/312 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/311 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.32%
1/312 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Reproductive system and breast disorders
Apnea
|
0.32%
1/311 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
0.00%
0/312 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
Other adverse events
| Measure |
Group 1: DTaP-IPV-Hep B-PRP~T
n=311 participants at risk
Participants received 3 doses of the DTaP-IPV-Hep B-PRP\~T vaccine, 1 dose each at 2, 4, and 6 months of age.
|
Group 2: PENTAXIM™ and ENGERIX B®
n=312 participants at risk
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea Not Otherwise Specified
|
38.3%
119/311 • Number of events 119 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
38.1%
119/312 • Number of events 119 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Gastrointestinal disorders
Vomiting Not Otherwise Specified
|
36.0%
112/311 • Number of events 112 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
35.3%
110/312 • Number of events 110 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
General disorders
Injection Site Erythemia
|
68.5%
213/311 • Number of events 213 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
62.2%
194/312 • Number of events 194 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
General disorders
Injection Site Induration
|
69.1%
215/311 • Number of events 215 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
59.6%
186/312 • Number of events 186 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
General disorders
Injection Site Edema
|
55.3%
172/311 • Number of events 172 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
44.9%
140/312 • Number of events 140 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
General disorders
Injection Site Pain
|
77.8%
242/311 • Number of events 242 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
64.7%
202/312 • Number of events 202 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
General disorders
Pyrexia
|
67.2%
209/311 • Number of events 209 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
56.7%
177/312 • Number of events 177 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
General disorders
Bronchiolitis
|
7.7%
24/311 • Number of events 24 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
8.7%
27/312 • Number of events 27 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Infections and infestations
Pharyngitis
|
7.4%
23/311 • Number of events 23 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
6.4%
20/312 • Number of events 20 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
46.9%
146/311 • Number of events 146 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
44.2%
138/312 • Number of events 138 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Nervous system disorders
Somnolence
|
62.7%
195/311 • Number of events 195 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
50.0%
156/312 • Number of events 156 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Psychiatric disorders
Crying
|
63.3%
197/311 • Number of events 197 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
57.1%
178/312 • Number of events 178 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Psychiatric disorders
Irritability
|
70.1%
218/311 • Number of events 218 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
61.9%
193/312 • Number of events 193 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Not Otherwise Specified
|
10.6%
33/311 • Number of events 33 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
13.5%
42/312 • Number of events 42 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Not Otherwise Specified
|
9.3%
29/311 • Number of events 29 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
9.0%
28/312 • Number of events 28 • Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER