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Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00619502
  Purpose

This is a follow-up of Study A3L10. Immunogenicity

  • To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
  • To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.

Safety

- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.


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

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Polio and Post-Polio Syndrome Whooping Cough
Drug Information available for: Hepatitis B Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Immunogenicity -Antibody persistence in a subset and booster response in all subjects [ Time Frame: 30 Days post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: December 2007
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL I.M

  Eligibility

Ages Eligible for Study:   15 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIMÔ and ENGERIX B® at 2, 3 and 4 months of age.
  • Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).
  • Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator.
  • 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 booster vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • 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 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 booster vaccination.
  • Any vaccination planned until second Visit.
  • History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
  • Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s).
  • Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
  • Any vaccine-related SAE that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10.
  • Febrile (temperature >=38.0°C) or acute illness on the day of inclusion.
  • Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619502

Locations
Turkey
Ankara, Turkey
Sponsors and Collaborators
Sanofi-Aventis
Investigators
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: A3L22
Study First Received: February 11, 2008
Last Updated: February 22, 2008
ClinicalTrials.gov Identifier: NCT00619502  
Health Authority: Turkey: Ministry 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
Healthy
Diphtheria
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

Additional relevant MeSH terms:
Bordetella Infections
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009