Clinical trial NCT00315055: Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Official title: Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Polio
Diphtheria
Pertussis
Keywords: Hepatitis B
Polio
Diphtheria
Pertussis
H influenzae type b
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-17
Enrollment: 310
Sex: ALL
Minimum age (years): 50
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Day 90 post first dose
Secondary outcomes:
measure: 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®
timeFrame: Day 90 post first dose
measure: 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®
timeFrame: Day 90 post first dose
measure: 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®
timeFrame: Day 0 (pre-vaccination) and Day 30 post-dose 3
measure: Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
timeFrame: Day 90 (30 Days post-dose 3)
measure: 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®
timeFrame: Day 0 to Day 7 post any dose
Other outcomes:
Locations:
city: Ankara
country: Turkey
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Trials
role: STUDY_DIRECTOR
References: