Immunogenicity and Safety of Pentaxim in South African Infants

April 16, 2012 updated by: Sanofi
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 3

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

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

1 day and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, Im
Other Names:
  • PENTAXIM™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immunogenicity of 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

Sanofi

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.

General Publications

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

October 1, 2005

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

January 1, 2010

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 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2I43

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.

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Conditions

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Locations

3
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