Immunogenicity and Safety of Pentaxim in South African Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00254969
First received: November 15, 2005
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.


Condition Intervention Phase
Diphtheria
Tetanus
Haemophilus Infections
Pertussis
Poliomyelitis
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
Phase 3

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:
  • To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine. [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: October 2005
Study Completion Date: January 2010
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, Im
Other Name: PENTAXIM™

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged < 24 hours on the day of inclusion

Exclusion Criteria:

  • At visit 01 (screening)
  • Illness at a stage that could interfere with trial conduct or completion.
  • Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG])
  • Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
  • Planned participation in another clinical trial during the present trial period
  • Blood or blood-derived products received since birth.
  • Mother known as seropositive to HIV or hepatitis B.
  • Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current seizures at visit 02 (first study vaccination)
  • Participation in another clinical trial preceding the first trial vaccination
  • 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.
  • Any vaccination preceding the first trial vaccination (except BCG)
  • History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
  • Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination
  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: NCT00254969

Locations
South Africa
Soweto, South Africa
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00254969     History of Changes
Other Study ID Numbers: E2I43
Study First Received: November 15, 2005
Last Updated: April 16, 2012
Health Authority: South Africa: Medicines Control Council

Keywords provided by Sanofi:
Diphteria
tetanus
haemophilus influenzae type b
poliomyelitis
pertussis

Additional relevant MeSH terms:
Diphtheria
Haemophilus Infections
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bordetella Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 26, 2014