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Immunogenicity and Safety of Pentaxim in South African Infants

Primary Purpose

Diphtheria, Tetanus, Haemophilus Infections

Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
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, haemophilus influenzae type b, poliomyelitis, pertussis

Eligibility Criteria

24 Hours - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2005
Last Updated
April 16, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00254969
Brief Title
Immunogenicity and Safety of Pentaxim in South African Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
212 (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
Other Intervention Name(s)
PENTAXIM™
Intervention Description
0.5 mL, Im
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine.
Time Frame
1 month post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Soweto
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
22273029
Citation
Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP~T vaccine (Pentaxim) given at 18 - 19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr Med J. 2011 Nov 28;101(12):879-83.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
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Immunogenicity and Safety of Pentaxim in South African Infants

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