Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Phase 3

Completed

• Conditions: Diphtheria; Pertussis; Hepatitis B; Polio
• Interventions: Biological: DTaP-IPV//PRP~T combined; Biological: DTaP-IPV-HB-PRP~T vaccine; Biological: Hepatitis B vaccine

• Registration Number: NCT00315055
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-13
• Study First Submitted QC: 2006-04-13
• Study First Posted: 2006-04-17
• Study Start: 2006-07
• Primary Completion: 2007-07
• Study Completion: 2008-02
• Results First Submitted: 2013-09-09
• Results First Submitted QC: 2014-01-02
• Results First Posted: 2014-02-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC	Hepatitis B vaccine	Participants will receive 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC	DTaP-IPV//PRP~T combined	Participants will receive 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.
Group 1: DTaP-IPV-Hep B-PRP-T	DTaP-IPV-HB-PRP~T vaccine	Participants will receive 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); One dose each at 2, 3, and 4 months of age.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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
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.