Diphtheria, Hepatitis B, Pertussis, Polio
Conditions
Keywords
Hepatitis B, Polio, Diphtheria, Pertussis, H influenzae type b
Brief summary
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP\ T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series. Immunogenicity * To assess pre- and post-primary series * To assess pre- and post-booster series.
Interventions
BIOLOGICALDTaP-IPV-HB-PRP~T vaccine
0.5 mL, Intramuscular (IM)
BIOLOGICALDTaP-IPV//PRP~T combined
0.5 mL, IM
BIOLOGICALHepatitis B vaccine
0.5 mL, IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Days to 71 Days
Healthy volunteers
Yes
Inclusion criteria
* Two-month old infants of either gender on the day of inclusion * Born at full term of pregnancy (\>=37 weeks) with a birth weight \>=2.5 kg * Informed consent form signed by the parent(s) or other legal representative(s) and an institution official other than an investigator * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy * Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances * Chronic illness at a stage that could interfere with trial conduct or completion * Blood or blood-derived products received since birth * Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination * Vaccination planned in the 4 weeks following trial vaccination * History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) * Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity * Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s) * Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * History of seizures * Febrile (axillary temperature 37.4°C \[rectal equivalent temperature \>=38.0°C\]) or acute illness on the day of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 90 post first dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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® | Day 90 post first dose | 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. |
| 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® | Day 90 post first dose | Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil. |
| 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® | Day 0 (pre-vaccination) and Day 30 post-dose 3 | 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). |
| Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Day 90 (30 Days post-dose 3) | 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. |
| 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® | Day 0 to Day 7 post any dose | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants were enrolled and treated from 01 June 2006 to 18 June 2007 in 1 clinical center in Turkey.
Pre-assignment details
A total of 310 participants who met the inclusion but non of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 155 |
| 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). | 155 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 4 |
Baseline characteristics
| Characteristic | PENTAXIM™ and ENGERIX® | DTaP-IPV-Hep B-PRP~T | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 155 Participants | 155 Participants | 310 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 2.08 Months STANDARD_DEVIATION 0.102 | 2.08 Months STANDARD_DEVIATION 0.09 | 2.08 Months STANDARD_DEVIATION 0.096 |
| Region of Enrollment Turkey | 155 Participants | 155 Participants | 310 Participants |
| Sex: Female, Male Female | 72 Participants | 67 Participants | 139 Participants |
| Sex: Female, Male Male | 83 Participants | 88 Participants | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 83 / 153 | 74 / 152 |
| serious Total, serious adverse events | 2 / 153 | 3 / 152 |
Outcome results
Primary
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
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.
Time frame: Day 90 post first dose
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTaP-IPV-Hep B-PRP~T | 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 |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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 | 96 Percentage of Participants |
Secondary
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 69.3 Titers |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 265 Titers |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 2.37 Titers |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 0.091 Titers |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 0.709 Titers |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 112 Titers |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 78.2 Titers |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 214 Titers |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 138 Titers |
Secondary
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®
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability
Time frame: Day 0 to Day 7 post any dose
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 64 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 55 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 58 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 48 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 17 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 17 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 17 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 16 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 12 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 11 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 12 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 23 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 24 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 44 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 48 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 40 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 41 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 38 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 30 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 45 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 38 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 36 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 27 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 35 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 40 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 67 Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 74 Participants |
Secondary
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®
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).
Time frame: Day 0 (pre-vaccination) and Day 30 post-dose 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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 |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 48 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 62 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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 |
Secondary
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®
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.
Time frame: Day 90 post first dose
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 99 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 78 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 98 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 77 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 97 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 44 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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 |
Secondary
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®
Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.
Time frame: Day 90 post first dose
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| DTaP-IPV-Hep B-PRP~T | 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 |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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 |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 94 Percentage of Participants |
| PENTAXIM™ and ENGERIX® PEDIATRIC | 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) | 100 Percentage of Participants |