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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00255021
First received: November 15, 2005
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Diphtheria
Tetanus
Poliomyelitis
Haemophilus Infections
Pertussis
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: December 2005
Study Completion Date: January 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
0.5 mL, IM
Other Name: PENTAXIM

  Eligibility

Ages Eligible for Study:   2 Months to 2 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255021

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

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00255021     History of Changes
Other Study ID Numbers: E2I34
Study First Received: November 15, 2005
Last Updated: April 13, 2012
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Sanofi:
Diphteria
Tetanus
Pertussis
Poliomyelitis
Haemophilus influenzae type b
acellular

Additional relevant MeSH terms:
Diphtheria
Haemophilus Infections
Poliomyelitis
Actinomycetales Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Corynebacterium Infections
Enterovirus Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Pasteurellaceae Infections
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014