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Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

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ClinicalTrials.gov Identifier: NCT00255021
Recruitment Status : Completed
First Posted : November 17, 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 and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Poliomyelitis Haemophilus Infections Pertussis Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : December 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : January 2009

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: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
0.5 mL, IM
Other Name: PENTAXIM


Outcome Measures
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Primary Outcome Measures :
  1. Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine [ Time Frame: 1 month post-vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   2 Months to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 53 to 70 days inclusive on the day of inclusion

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 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.
  • Blood or blood-derived products received in the past.
  • Mother known as seropositive to HIV or hepatitis B
  • Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin [BCG])
  • History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
  • Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae 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): NCT00255021


Locations
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Thailand
Bangkok, Thailand
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
More Information
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Additional Information:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00255021    
Other Study ID Numbers: E2I34
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: April 2012
Keywords provided by Sanofi:
Diphteria
Tetanus
Pertussis
 Poliomyelitis
Haemophilus influenzae type b
acellular
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Haemophilus Infections
Poliomyelitis
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
 Nervous System Diseases
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Pasteurellaceae Infections