Study Comparing a DTaP HB PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00348881

Purpose

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hepatitis B Influenza	Biological: DTaP-HB-PRP~T combined vaccine Biological: Tritanrix-HepB/Hib™ vaccine	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, Double Blind (Subject, Caregiver, Investigator, 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-HB-PRP~T combined vaccine [ Time Frame: 7 days post-dose 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To provide information concerning the immunogenicity of Tritanrix-HepB/Hib Vaccine [ Time Frame: 30 days post-dose 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	2133
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	42 Days to 50 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

At Screening:

0 to 3 day old infants
Born at full term of pregnancy (>= 37 weeks) with a birth weight >=2.5 kg
Apgar score >= 7 at three minutes after birth
Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)

At Inclusion:

Six weeks of age
Received a dose of HB in the first three days of life
Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

At Screening:

Illness at a stage that could interfere with trial conduct or completion
Any vaccination before HB vaccination (except BCG given at birth)
Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
Acute illness on the day of screening.

At Screening and at Inclusion:

Blood or blood-derived products received since birth
Planned participation in another clinical trial during the present trial period
Mother known as seropositive to HIV or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)

At Inclusion:

Non-trial vaccine administered since birth, except BCG
Participation in another clinical trial before the first trial vaccination
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 the trial vaccine or a vaccine containing the same substances
Chronic illness at a stage that could interfere with trial conduct or completion
Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
History of seizures
Febrile (rectal temperature >= 38.0°C) or acute illness on the day of inclusion.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348881

Locations

Philippines
Filinvest
Corporate City, Philippines
Philippines, Muntinlupa City

Alabang, Muntinlupa City, Philippines

Tunasan,, Muntinlupa City, Philippines

Putatan,, Muntinlupa City, Philippines

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:	AL201
Study First Received:	July 5, 2006
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00348881
Health Authority:	Philippines: Bureau of Food and Drugs

Keywords provided by Sanofi-Aventis:

Diphtheria
Tetanus
Pertussis
Hepatitis B Hansenula (HB)
Haemophilus influenzae type b

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Haemophilus influenzae
Hepatitis, Viral, Human
Whooping Cough
Cough
Healthy
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
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 14, 2009