Trial Outcomes & Findings for Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule (NCT NCT00315055)
NCT ID: NCT00315055
Last Updated: 2014-09-12
Results Overview
Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
310 participants
Primary outcome timeframe
Day 90 post first dose
Results posted on
2014-09-12
Participant Flow
Participants were enrolled and treated from 01 June 2006 to 18 June 2007 in 1 clinical center in Turkey.
A total of 310 participants who met the inclusion but non of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
DTaP-IPV-Hep B-PRP~T
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX®
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
155
|
|
Overall Study
COMPLETED
|
152
|
150
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
DTaP-IPV-Hep B-PRP~T
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX®
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Baseline characteristics by cohort
| Measure |
DTaP-IPV-Hep B-PRP~T
n=155 Participants
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX®
n=155 Participants
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
155 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
310 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
|
2.08 Months
STANDARD_DEVIATION 0.090 • n=5 Participants
|
2.08 Months
STANDARD_DEVIATION 0.102 • n=7 Participants
|
2.08 Months
STANDARD_DEVIATION 0.096 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
155 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90 post first dosePopulation: Seroprotection against HBs was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T
n=134 Participants
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX® PEDIATRIC
n=128 Participants
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines
|
94 Percentage of Participants
|
96 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 90 post first dosePopulation: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T
n=145 Participants
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX® PEDIATRIC
n=141 Participants
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-PRP (≥ 0.15 µg/mL; N = 140, 138)
|
91 Percentage of Participants
|
98 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Diphtheria (≥0.01 IU/mL; N = 144, 138)
|
99 Percentage of Participants
|
97 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Diphtheria (≥0.1 IU/mL; N=144, 138)
|
34 Percentage of Participants
|
44 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-HBs (≥ 100 mIU/mL; N = 134, 128)
|
65 Percentage of Participants
|
78 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-PRP (≥ 1.0 µg/mL; N = 140, 138)
|
73 Percentage of Participants
|
77 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Tetanus (≥0.01 IU/mL; N = 145, 139)
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Tetanus (≥0.1 IU/mL; N = 145, 139)
|
100 Percentage of Participants
|
99 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 90 post first dosePopulation: Anti poliovirus antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T
n=145 Participants
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX® PEDIATRIC
n=141 Participants
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Polio 1 (N = 87, 94)
|
98 Percentage of Participants
|
98 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Polio 2 (N = 75, 83)
|
95 Percentage of Participants
|
94 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Polio 3 (N = 76, 78)
|
97 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-dose 3Population: Anti-pertussis antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90).
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T
n=145 Participants
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX® PEDIATRIC
n=141 Participants
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-FHA (Post-dose 3; N = 144, 137)
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-PT (Pre-dose 1; N = 143, 140)
|
55 Percentage of Participants
|
48 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-PT (Post-dose 3; N = 143, 140)
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-FHA (Pre-dose 1; N = 145, 140)
|
65 Percentage of Participants
|
62 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 90 (30 Days post-dose 3)Population: Geometric Mean Titers were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T
n=145 Participants
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX® PEDIATRIC
n=141 Participants
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-FHA (N = 144, 137)
|
102 Titers
Interval 90.4 to 114.0
|
69.3 Titers
Interval 62.0 to 77.6
|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-HBs (N = 134, 128)
|
149 Titers
Interval 115.0 to 191.0
|
265 Titers
Interval 205.0 to 342.0
|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-PRP (N = 140, 138)
|
2.12 Titers
Interval 1.62 to 2.77
|
2.37 Titers
Interval 1.91 to 2.94
|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Diphtheria (N = 144, 138)
|
0.071 Titers
Interval 0.06 to 0.084
|
0.091 Titers
Interval 0.075 to 0.11
|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Tetanus (N = 145, 139)
|
0.839 Titers
Interval 0.731 to 0.962
|
0.709 Titers
Interval 0.625 to 0.804
|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Polio 1 (N = 87, 94)
|
102 Titers
Interval 74.9 to 138.0
|
112 Titers
Interval 85.4 to 147.0
|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Polio 2 (N = 75, 83)
|
73.5 Titers
Interval 52.9 to 102.0
|
78.2 Titers
Interval 58.2 to 105.0
|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-Polio 3 (N = 76, 78)
|
133 Titers
Interval 93.0 to 190.0
|
214 Titers
Interval 159.0 to 288.0
|
|
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anti-PT (N = 143, 140)
|
123 Titers
Interval 109.0 to 139.0
|
138 Titers
Interval 122.0 to 155.0
|
SECONDARY outcome
Timeframe: Day 0 to Day 7 post any dosePopulation: Solicited reactions were assessed in all participants who received at least 1 injection of study vaccine (Safety Analysis Set) according to the vaccine actually received.
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T
n=153 Participants
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX® PEDIATRIC
n=152 Participants
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Somnolence Post-dose 2 (N = 152, 150)
|
35 Participants
|
38 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Somnolence Post-dose 3 (N = 152, 150)
|
26 Participants
|
36 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anorexia Post-dose 1 (N = 153, 152)
|
43 Participants
|
27 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anorexia Post-dose 2 (N = 152, 150)
|
48 Participants
|
35 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Anorexia Post-dose 3 (N = 152, 150)
|
42 Participants
|
40 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Irritability Post-dose 1 (N = 153, 152)
|
83 Participants
|
67 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Irritability Post-dose 2 (N = 152, 150)
|
81 Participants
|
74 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Irritability Post-dose 3 (N = 152, 150)
|
71 Participants
|
64 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Pain Post-dose 1 (N = 153, 152)
|
70 Participants
|
55 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Pain Post-dose 2 (N = 152, 150)
|
66 Participants
|
58 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Pain Post-dose 3 (N = 152, 150)
|
57 Participants
|
48 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Erythema Post-dose 1 (N = 153, 152)
|
23 Participants
|
17 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Erythema Post-dose 2 (N = 152, 150)
|
25 Participants
|
17 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Erythema Post-dose 3 (N = 152, 150)
|
30 Participants
|
17 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Swelling Post-dose 1 (N = 153, 152)
|
21 Participants
|
16 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Swelling Post Dose 2 (N=152, 150)
|
21 Participants
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Injection site Sweling Post Dose 3 (N = 152, 150)
|
17 Participants
|
11 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Pyrexia Post-dose 1 (N = 153, 152)
|
15 Participants
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Pyrexia Post-dose 2 (N = 152, 150)
|
33 Participants
|
23 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Pyrexia Post-dose 3 (N = 152, 150)
|
41 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Vomiting Post-dose 1 (N = 153, 152)
|
57 Participants
|
44 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Vomiting Post-dose 2 (N = 152, 150)
|
55 Participants
|
48 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Vomiting Post-dose 3 (N = 152, 150)
|
44 Participants
|
40 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Crying Post-dose 1 (N = 153, 152)
|
51 Participants
|
41 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Crying Post-dose 2 (N = 152, 150)
|
54 Participants
|
38 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Crying Post-dose 3 (N = 152, 150)
|
45 Participants
|
30 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Somnolence Post-dose 1 (N = 153, 152)
|
51 Participants
|
45 Participants
Interval 0.0 to 0.0
|
Adverse Events
DTaP-IPV-Hep B-PRP~T
Serious events: 2 serious events
Other events: 83 other events
Deaths: 0 deaths
PENTAXIM™ and ENGERIX®
Serious events: 3 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTaP-IPV-Hep B-PRP~T
n=153 participants at risk
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX®
n=152 participants at risk
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/153 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
0.66%
1/152 • Number of events 1 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
Infections and infestations
Bronchopneumonia
|
0.65%
1/153 • Number of events 1 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
0.66%
1/152 • Number of events 1 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.65%
1/153 • Number of events 1 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
0.00%
0/152 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/153 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
0.66%
1/152 • Number of events 1 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
Other adverse events
| Measure |
DTaP-IPV-Hep B-PRP~T
n=153 participants at risk
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
PENTAXIM™ and ENGERIX®
n=152 participants at risk
Participants received 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
37.3%
57/153 • Number of events 57 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
31.6%
48/152 • Number of events 48 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
General disorders
Injection Site Pain
|
45.8%
70/153 • Number of events 70 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
38.2%
58/152 • Number of events 58 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
General disorders
Injection Site Erythema
|
19.6%
30/153 • Number of events 30 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
11.2%
17/152 • Number of events 17 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
General disorders
Injection Site Swelling
|
13.7%
21/153 • Number of events 21 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
10.5%
16/152 • Number of events 16 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
General disorders
Irritability
|
54.2%
83/153 • Number of events 83 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
48.7%
74/152 • Number of events 74 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
General disorders
Pyrexia
|
27.0%
41/152 • Number of events 41 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
15.8%
24/152 • Number of events 24 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.4%
48/153 • Number of events 48 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
26.3%
40/152 • Number of events 40 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
Nervous system disorders
Somnolence
|
33.3%
51/153 • Number of events 51 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
29.6%
45/152 • Number of events 45 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
|
Psychiatric disorders
Crying
|
35.3%
54/153 • Number of events 54 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
27.0%
41/152 • Number of events 41 • Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
|
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