Immunogenicity and Safety of Pentaxim in South African Infants

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

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
Haemophilus Infections
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™


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00254969

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

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi 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:
haemophilus influenzae type b

Additional relevant MeSH terms:
Haemophilus Infections
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
Nervous System Diseases
Neuromuscular Diseases
Pasteurellaceae Infections
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases processed this record on October 08, 2015