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Immunogenicity and Safety of Pentaxim™ in an Indian Population

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ClinicalTrials.gov Identifier: NCT00259337
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life.

Safety:

This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).


Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Polio Pertussis Haemophilus Infections Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.
Study Start Date : February 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diphtheria Tetanus

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
0.5 mL, IM
Other Name: PENTAXIM™


Outcome Measures
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Primary Outcome Measures :
  1. To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 19 months ]

Eligibility Criteria
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Ages Eligible for Study:   42 Days to 56 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 42 to 56 days inclusive on the day of inclusion
  • Born at full term pregnancy (> 37 weeks) with a birth weight ≥ 2.5 kg
  • Informed consent form signed by the parent(s) or other legal representative
  • 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 (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
  • 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 in the past.
  • Any vaccination preceding the trial vaccination (except BCG and hepatitis B)
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically).
  • Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current seizures
  • Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259337


Locations
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India
New Delhi, India
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00259337    
Other Study ID Numbers: E2I41
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: April 2012
Keywords provided by Sanofi:
Diphteria
Tetanus
Polio
 Acellular Pertussis
Hib
Haemophilus influenzae type B
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Haemophilus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
 Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Pasteurellaceae Infections