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Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP HB PRP~T Combined Vaccine in Filipino Infants
This study is ongoing, but not recruiting participants.
First Received: August 9, 2007   Last Updated: August 4, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00514709
  Purpose

DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.

Primary Objectives:

  • To describe the antibody persistence following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™
  • To describe the effect of a booster dose of DTaP-HB-PRP~T following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™

Secondary Objective:

To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with OPV.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Hepatitis B
Heamophilus Influenza
Biological: DTaP HB PRP~T Combined Vaccine
Biological: DTaP-HB-PRP~T vaccine
Phase III

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

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Antibody persistence before the booster dose with DTaP-HB-PRP~T in a subset of subjects in the study [ Time Frame: Before and after booster dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 2133
Study Start Date: September 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: DTaP HB PRP~T Combined Vaccine
0.5 mL dose, IM
2: Experimental Biological: DTaP-HB-PRP~T vaccine
0.5 mL dose, IM

Detailed Description:

This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP~T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP~T combined vaccine or Tritanrix-HepB/Hib™ vaccine and having received a first dose of HB vaccine (Recomvax B™) at birth in a previous study.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive)
  • Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, and received hepatitis B vaccine at birth
  • Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
  • Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to 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 in the last 3 months
  • Any vaccination in the 4 weeks preceding the trial vaccination
  • Vaccination planned in the 4 weeks following the trial vaccination
  • Febrile (temperature >=38.0°C) or acute illness on the day of inclusion
  • History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
  • Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliovirus 3 types antigen, since the end of the primary series
  • Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
  • Serious adverse event related to any vaccination in the AL201 study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514709

Locations
Philippines, Alabang
Muntinlupa City, Alabang, Philippines
Philippines, Alabang Junction Alabang
Muntinlupa City, Alabang Junction Alabang, Philippines
Philippines, Bayanan Annex
Muntinlupa City, Bayanan Annex, Philippines
Philippines, Cupang
Muntinlupa City, Cupang, Philippines
Philippines, Filinvest
Muntinlupa City, Filinvest, Philippines
Philippines, Putatan
Muntinlupa City, Putatan, Philippines
Philippines, Tunasan
Muntinlupa City, Tunasan, Philippines
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur, Inc. ( Medical Monitor )
Study ID Numbers: AL204
Study First Received: August 9, 2007
Last Updated: August 4, 2008
ClinicalTrials.gov Identifier: NCT00514709     History of Changes
Health Authority: Philippines: Department of Health

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
Orthomyxoviridae Infections
Diphtheria
Tetanus
Gram-Negative Bacterial Infections
Virus Diseases
Hepatitis
Antibodies
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Influenza, Human
Hepatitis B
DNA Virus Infections
Clostridium Infections
Immunoglobulins

Additional relevant MeSH terms:
Bacterial Infections
RNA Virus Infections
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Orthomyxoviridae Infections
Diphtheria
Tetanus
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
Clostridium Infections

ClinicalTrials.gov processed this record on September 04, 2009