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

Brief Title

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

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 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®

Condition

Hepatitis B

Intervention

DTaP-IPV-HB-PRP~T vaccine

Study Arms / Comparison Groups

 Group 1: DTaP-IPV-Hep B-PRP-T

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

310

Start Date

July 2006

Completion Date

February 2008

Primary Completion Date

July 2007

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.
      

Gender

All

Ages

50 Days - 71 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Clinical Trials, , 

Location Countries

Turkey

Location Countries

Turkey

NCT ID

NCT00315055

Organization ID

A3L10

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company

Study Sponsor

Clinical Trials, Study Director, Sanofi Pasteur, a Sanofi Company

Verification Date

September 2014