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

Primary Purpose

Diphtheria, Tetanus, Poliomyelitis

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphteria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, acellular

Eligibility Criteria

2 Months - 2 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine

Secondary Outcome Measures

Full Information

First Posted
November 15, 2005
Last Updated
April 13, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00255021
Brief Title
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Poliomyelitis, Haemophilus Infections, Pertussis
Keywords
Diphteria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, acellular

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
Other Intervention Name(s)
PENTAXIM
Intervention Description
0.5 mL, IM
Primary Outcome Measure Information:
Title
Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine
Time Frame
1 month post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

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

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