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Comparison of DTaP IPV HB PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00362336
First received: August 8, 2006
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  Purpose

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 D, T, polio, HB, and 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.


Condition Intervention Phase
Hepatitis B
Polio
Diphtheria
Pertussis
Haemophilus Influenzae Type b
 Biological: DTaP-IPV-HB-PRP~T
Biological: CombAct-HIB®
Biological: Engerix B® Pediatric
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity Study of a DTaP IPV HB 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immune response of hexavalent DTaP-IPV-HB-PRP~T combined vaccine. [ Time Frame: 1 month post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety after administration of hexavalent DTaP-IPV-HB-PRP~T combined vaccine. [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 622
Study Start Date: August 2006
Study Completion Date: August 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: DTaP-IPV-Hep B-PRP-T Biological: DTaP-IPV-HB-PRP~T
0.5 mL, IM
Experimental: Group 2: CombAct-HIB™ + OPV Biological: CombAct-HIB®
0.5 mL, IM
Active Comparator: Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth) Biological: Engerix B® Pediatric
0.5 mL, IM

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 0 to 3 day old infants
  • Mother seronegative for 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 BCG and trial vaccinations) from birth to 18 weeks of age
  • OPV administration at birth
  • Known maternal history of HIV, HB (HbsAg carrier) or Hepatitis C seropositivity
  • Thrombocytopenia or bleeding disorder contraindicating IM vaccination
  • History of seizures
  • Febrile or acute illness on the day of inclusion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362336

Locations
South Africa
Soweto, Johannesburg, South Africa, 2013
Bertsham, South Africa
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Trials Sanofi Pasteur Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00362336     History of Changes
Other Study ID Numbers: A3L15
Study First Received: August 8, 2006
Last Updated: September 30, 2011
Health Authority: South Africa: Department of Health

Keywords provided by Sanofi:
Hepatitis B
Polio
Diphtheria
Pertussis
H. influenzae type b

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Whooping Cough
Poliomyelitis
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013