- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00255021
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
April 13, 2012 updated by: Sanofi
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
186
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 2 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
0.5 mL, IM
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine
Time Frame: 1 month post-vaccination
|
1 month post-vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
November 15, 2005
First Submitted That Met QC Criteria
November 15, 2005
First Posted (Estimate)
November 17, 2005
Study Record Updates
Last Update Posted (Estimate)
April 16, 2012
Last Update Submitted That Met QC Criteria
April 13, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Neuromuscular Diseases
- Central Nervous System Infections
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Clostridium Infections
- Corynebacterium Infections
- Myelitis
- Pasteurellaceae Infections
- Whooping Cough
- Tetanus
- Diphtheria
- Poliomyelitis
- Haemophilus Infections
Other Study ID Numbers
- E2I34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pertussis
-
National Institute of Allergy and Infectious Diseases...CompletedPertussis | Pertussis ImmunisationUnited States
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussis (Whooping Cough)France
-
Institut PasteurHopital Universitaire Robert-Debre; Hospices Civils de Lyon; Centre Hospitalier... and other collaboratorsNot yet recruitingBordetella Pertussis, Whooping CoughFrance
-
ILiAD BiotechnologiesActive, not recruitingBordetella Pertussis, Whooping CoughUnited Kingdom, Australia, Costa Rica
-
University of TurkuGlaxoSmithKline; Sanofi Pasteur, a Sanofi CompanyCompleted
-
GlaxoSmithKlineCompletedPertussis | Pertussis VaccinesHungary
-
Institut PasteurAgence de Médecine Préventive, France; Institut Pasteur de Madagascar; Institut...CompletedBordetella Pertussis, Whooping CoughCambodia, Madagascar, Togo
-
Institut PasteurSanofi Pasteur, a Sanofi Company; Institut Pasteur of Cote d'IvoireCompletedBordetella Pertussis, Whooping CoughCôte D'Ivoire
-
University of SouthamptonRecruitingPertussis/Whooping CoughUnited Kingdom
-
University of VirginiaUnknownCarriage of Bordetella PertussisUnited States
Clinical Trials on Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
-
SanofiCompletedPertussis | Tetanus | Diphtheria | Poliomyelitis | Haemophilus InfectionsSouth Africa
-
SanofiCompletedPertussis | Tetanus | Diphtheria | Poliomyelitis | Haemophilus Influenzae Type bChina
-
CanSino Biologics Inc.Active, not recruitingDiphtheria, Tetanus and Acellular PertussisChina
-
SanofiCompletedPertussis | Tetanus | Diphtheria | Polio | Haemophilus InfectionsIndia
-
GlaxoSmithKlineCompletedTetanus | Diphtheria | Acellular Pertussis | Haemophilus Influenzae Type bChina
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Whooping Cough | Tetanus | DiphtheriaUnited States
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Tetanus | Diphtheria | PoliomyelitisKorea, Republic of
-
SanofiCompletedPertussis | Tetanus | DiphtheriaUnited States
-
CanSino Biologics Inc.Henan Center for Disease Control and PreventionCompletedPertussis | Tetanus | DiphtheriaChina
-
Sanofi Pasteur, a Sanofi CompanyCompletedTetanus | Diphtheria | PoliomyelitisFrance