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

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

MedlinePlus related topics:

Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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 ]

Estimated Enrollment:	300
Study Start Date:	October 2005
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib 0.5 mL, Im

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:	Clinical Trials	sanofi pasteur

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi pasteur, Inc. ( Medical Director )
Study ID Numbers:	E2I43
First Received:	November 15, 2005
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00254969
Health Authority:	South Africa: Medicines Control Council

Keywords provided by Sanofi-Aventis:

Diphteria

tetanus

haemophilus influenzae type b

poliomyelitis

pertussis

Study placed in the following topic categories:

Bacterial Infections

Haemophilus Infections

Spinal Cord Diseases

Whooping Cough

Tetanus

Whooping cough

Gram-Negative Bacterial Infections

Gram-Positive Bacterial Infections

Respiratory Tract Diseases

Respiratory Tract Infections

Neuromuscular Diseases

Motor Neuron Disease

Haemophilus influenzae

Cough

Picornaviridae Infections

Central Nervous System Diseases

Degenerative motor system disease

Diphtheria

Motor neuron disease

Virus Diseases

Central Nervous System Infections

Poliomyelitis

Influenza, Human

Myelitis

Enterovirus Infections

Clostridium Infections

Additional relevant MeSH terms:

Bordetella Infections

Pasteurellaceae Infections

RNA Virus Infections

Corynebacterium Infections

Nervous System Diseases

Central Nervous System Viral Diseases

Infection

Actinomycetales Infections

ClinicalTrials.gov processed this record on August 21, 2008

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