Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
1 other identifier
interventional
186
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2005
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2005
CompletedFirst Posted
Study publicly available on registry
November 17, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedApril 16, 2012
April 1, 2012
1.8 years
November 15, 2005
April 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine
1 month post-vaccination
Study Arms (1)
1
EXPERIMENTALInterventions
0.5 mL, IM
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Unknown Facility
Bangkok, Thailand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Sanofi Pasteur, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2005
First Posted
November 17, 2005
Study Start
December 1, 2005
Primary Completion
September 1, 2007
Study Completion
January 1, 2009
Last Updated
April 16, 2012
Record last verified: 2012-04