We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety of Pentaxim in South African Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00254969
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : April 17, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diphtheria Tetanus Haemophilus Infections Pertussis Poliomyelitis Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2005
Primary Completion Date : May 2008
Study Completion Date : January 2010


Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, Im
Other Name: PENTAXIM™


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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): NCT00254969


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

Additional Information:
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
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Poliomyelitis
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
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Pasteurellaceae Infections