Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

Phase 4

Completed

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

• Registration Number: NCT00255021
• Lead Sponsor: Sanofi

Brief Summary

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-17
• Study Start: 2005-12
• Primary Completion: 2007-09
• Study Completion: 2009-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Aged 53 to 70 days inclusive on the day of inclusion

Exclusion Criteria

• Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
• Planned participation in another clinical trial during the present trial period
• 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.
• Blood or blood-derived products received in the past.
• Mother known as seropositive to HIV or hepatitis B
• Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin [BCG])
• History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
• Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• History of/current seizures
• Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine	1 month post-vaccination