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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00362336

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diphtheria Flu Hepatitis Hepatitis B Polio and Post-Polio Syndrome Whooping Cough

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	715
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: DTaP-IPV-HB-PRP~T 0.5 mL, IM
2: Experimental	Biological: CombAct-HIB® 0.5 mL, IM
3: Active Comparator	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

Bertsham, South Africa
South Africa, Johannesburg

Soweto, Johannesburg, South Africa, 2013

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi Pasteur, Inc. ( Medical Monitor )
Study ID Numbers:	A3L15
Study First Received:	August 8, 2006
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00362336 History of Changes
Health Authority:	South Africa: Department of Health

Keywords provided by Sanofi-Aventis:

Hepatitis B
Polio
Diphtheria
Pertussis
H. influenzae type b

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Haemophilus Influenzae
Hepatitis, Viral, Human
Whooping Cough
Cough
Orthomyxoviridae Infections
Diphtheria
Gram-Negative Bacterial Infections
Virus Diseases

Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Influenza, Human
Hepatitis B
DNA Virus Infections

Additional relevant MeSH terms:

Bacterial Infections
RNA Virus Infections
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Orthomyxoviridae Infections
Diphtheria
Infection
Hepadnaviridae Infections
Actinomycetales Infections
Gram-Negative Bacterial Infections

Virus Diseases
Hepatitis
Bordetella Infections
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Corynebacterium Infections
Hepatitis B
Influenza, Human
DNA Virus Infections

ClinicalTrials.gov processed this record on September 02, 2009