Immunogenicity and Safety of Pentaxim in South African Infants - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00254969

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 III

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:

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

Drug Information available for: Tetanus Vaccine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254969

Locations

South Africa

Soweto, South Africa

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP~T vaccine (Pentaxim) given at 18 - 19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr Med J. 2011 Nov 28;101(12):879-83.

Responsible Party:	Medical Director, Sanofi pasteur, Inc.
ClinicalTrials.gov Identifier:	NCT00254969 History of Changes
Other Study ID Numbers:	E2I43
Study First Received:	November 15, 2005
Last Updated:	February 4, 2010
Health Authority:	South Africa: Medicines Control Council

Keywords provided by Sanofi-Aventis:

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 February 12, 2012