Brief Title
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
Official Title
Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants
Brief Summary
The purpose of this study is to document the immunological response to the investigational
hexavalent vaccine at the 6, 10, and 14 weeks schedule
The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined
vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric
and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B
(HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6,
10, and 14 weeks) with no HB vaccination at birth.
The secondary Objectives are:
To describe the safety in terms of any adverse events in the first 28 days after each
injection and any serious adverse events during the entire trial.
To describe Immunogenicity after the primary series and prior to and after a booster
vaccination.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Secondary Outcome
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Condition
Hepatitis B
Intervention
DTaP-IPV-HB-PRP~T
Study Arms / Comparison Groups
Group 1: DTaP-IPV-Hep B-PRP-T
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
622
Start Date
August 2006
Completion Date
August 2009
Primary Completion Date
May 2008
Eligibility Criteria
Inclusion Criteria:
- 0 to 3 day old infants
- Mother seronegative for Human Immunodeficiency Virus (HIV)
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Apgar score >7 at 5 or 10 minutes of life
- Informed consent form signed by a parent or other legal guardian and by an independent
witness if the parent or other legal guardian is illiterate
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
- Current or planned participation in another clinical trial during the entire duration
of the present trial
- Suspected congenital or acquired immunodeficiency
- Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based
on clinical history
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received since birth
- Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from
birth to 18 weeks of age
- Oral Poliovirus Vaccine (OPV) administration at birth
- Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C
seropositivity
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
- History of seizures
- Febrile or acute illness on the day of inclusion.
Gender
All
Ages
N/A - 3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Clinical Trials, ,
Location Countries
South Africa
Location Countries
South Africa
Administrative Informations
NCT ID
NCT00362336
Organization ID
A3L15
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Clinical Trials, Study Director, Sanofi Pasteur Inc.
Verification Date
April 2014