Purpose

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.

The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.

The secondary objectives are:

  • To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
  • To assess the overall safety in each group one month after the third dose of the primary series.

Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
 Biological: DTaP-IPV-HB-PRP~T vaccine
Biological: DTaP-IPV-HB-PRP~T vaccine
Biological: DTaP-HBV-IPV vaccine
 Phase III

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

ChemIDplus related topics:   Hepatitis B Vaccines   Infanrix hexa  

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 immunogenicity of DTaP-IPV-HB-PRP~T after vaccination. [ Time Frame: 1 Month post-dose 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:   1190
Study Start Date:   November 2006
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Vaccine Batch A
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
2: Experimental
Vaccine Batch B
3: Experimental
Vaccine Batch C
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
4: Active Comparator Biological: DTaP-HBV-IPV vaccine
0.5 mL, IM

  Eligibility
Ages Eligible for Study:   2 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria :

  • Two 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 guardian and two independent witnesses
  • Able to attend all scheduled visits and to comply with all trial procedures
  • Received BCG vaccine between birth and one month of life in agreement with the national immunization calendar.

Exclusion Criteria :

  • Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency
  • 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 four weeks preceding the first trial visit
  • Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
  • Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
  • Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
  • Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of seizures
  • Febrile (rectal equivalent 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: NCT00404651

Locations
Mexico
      Monterrey, Mexico
      Puebla, Mexico

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Clinical Trials     sanofi pasteur    
Mexico
      Monterrey, Mexico
      Puebla, Mexico
Sanofi-Aventis
Study Director:     Clinical Trials     sanofi pasteur    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 
Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Sanofi Pasteur Inc ( Medical Monitor )
Study ID Numbers:   A3L11
First Received:   November 28, 2006
Last Updated:   May 8, 2008
ClinicalTrials.gov Identifier:   NCT00404651
Health Authority:   Mexico: Ministry of Health

Keywords provided by Sanofi-Aventis:
Diphtheria  
Tetanus  
Pertussis  
Hepatitis B
Poliomyelitis
Invasive Haemophilus influenzae type b.

Study placed in the following topic categories:
Bacterial Infections
Liver Diseases
Spinal Cord Diseases
Whooping Cough
Hepatitis, Viral, Human
Healthy
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Mycoses
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Neuromuscular Diseases
Hepatitis B
Motor Neuron Disease
Haemophilus influenzae
Cough
Picornaviridae Infections
Central Nervous System Diseases
Degenerative motor system disease

Additional relevant MeSH terms:
Diphtheria
RNA Virus Infections
Nervous System Diseases
Central Nervous System Viral Diseases
Infection
Hepadnaviridae Infections
Actinomycetales Infections
Bordetella Infections
Virus Diseases
Digestive System Diseases
Respiratory Tract Diseases
Bacterial Infections and Mycoses
Corynebacterium Infections

Source: National Library of Medicine (NLM) June 26, 2008

  


 
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