Immunogenicity and Safety of Pentaxim in South African Infants - Tabular View

Tracking Information

First Received Date ^ICMJE

November 15, 2005

Last Updated Date

March 31, 2008

Start Date ^ICMJE

October 2005

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine. [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00254969 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Immunogenicity and Safety of Pentaxim in South African Infants

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diphtheria
Tetanus
Haemophilus Infections
Pertussis
Poliomyelitis

Intervention ^ICMJE

Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

September 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

South Africa

Administrative Information

NCT ID ^ICMJE

NCT00254969

Responsible Party

Medical Director, Sanofi pasteur, Inc.

Study ID Numbers ^ICMJE

E2I43

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

sanofi pasteur

Information Provided By

Sanofi-Aventis

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP