Safety of DTaP-IPV-HB-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months. - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00313911

Purpose

To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and OPV after any of the three vaccinations at 2, 4, and 6 months of age for each subject.

To evaluate the overall safety in terms of:

Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.

Immunogenicity:

To document the immune response to HB antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B Hepatitis B	Biological: DTaP-IPV-HB-PRP~T Biological: Tritanrix-HepB/Hib	Phase III

MedlinePlus related topics: Diphtheria Flu Hepatitis Hepatitis B Tetanus Whooping Cough

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the safety after administration of DTaP-IPV-HB-PRP~T combined vaccine. [ Time Frame: 7 days, post-vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To provide information concerning the immune response of three batches of DTaP-IPV-HB-PRP~T and the reference vaccine. [ Time Frame: Day 150 ] [ Designated as safety issue: No ]

Estimated Enrollment:	2133
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: DTaP-IPV-HB-PRP~T 0.5 mL, IM
2: Active Comparator	Biological: Tritanrix-HepB/Hib 0.5 mL, IM

Eligibility

Ages Eligible for Study:	50 Days to 71 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

2 months old infants 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 one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
Able to attend all scheduled visits and to comply with all trial procedures
Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.

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 corticosteroids therapy
Subjects with congenital or acquired immunodeficiency in the child's surrounding
Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or 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 in the 4 weeks preceding the first trial vaccination
Vaccination planned in the 4 weeks following the trial vaccination
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
Coagulopathy, thrombocytopenia or a 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: NCT00313911

Locations

Mexico

Mexico DF, Mexico
Peru

Lima, Peru

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur, Inc ( Medical Monitor )
Study ID Numbers:	A3L04
Study First Received:	April 11, 2006
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00313911
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Mexico: Ministry of Health

Keywords provided by Sanofi-Aventis:

Diphtheria
Tetanus
Pertussis
Recombinant Hepatitis B

Poliomyelitis
Haemophilus influenzae type b
Tetanus protein

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Haemophilus influenzae
Hepatitis, Viral, Human
Whooping Cough
Cough
Orthomyxoviridae Infections
Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

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

Additional relevant MeSH terms:

Bordetella Infections
RNA Virus Infections
Corynebacterium Infections

Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009