Immunogenicity and Safety of Pentaxim in South African Infants

Phase 3

Completed

• Conditions: Diphtheria; Tetanus; Haemophilus Infections; Pertussis; Poliomyelitis
• Interventions: Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

• Registration Number: NCT00254969
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-17
• Primary Completion: 2008-05
• Study Completion: 2010-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib	-

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine.	1 month post-vaccination