Comparison of DTaP IPV HB PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi-Aventis

ClinicalTrials.gov Identifier:

NCT00362336

First received: August 8, 2006

Last updated: September 30, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 8, 2006

Last Updated Date

September 30, 2011

Start Date ^ICMJE

August 2006

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

To provide information concerning the immune response of hexavalent DTaP-IPV-HB-PRP~T combined vaccine. [ Time Frame: 1 month post-dose 3 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00362336 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To provide information concerning the safety after administration of hexavalent DTaP-IPV-HB-PRP~T combined vaccine. [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Comparison of DTaP IPV HB PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

Official Title ^ICMJE

Immunogenicity Study of a DTaP IPV HB PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants

Brief Summary

The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule

The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to D, T, polio, HB, and PRP, one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.

The secondary Objectives are:

To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.

To describe Immunogenicity after the primary series and prior to and after a booster vaccination.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Hepatitis B
Polio
Diphtheria
Pertussis
Haemophilus Influenzae Type b

Intervention ^ICMJE

Biological: DTaP-IPV-HB-PRP~T
0.5 mL, IM
Biological: CombAct-HIB®
0.5 mL, IM
Biological: Engerix B® Pediatric
0.5 mL, IM

Study Arm (s)

Experimental: Group 1: DTaP-IPV-Hep B-PRP-T
Intervention: Biological: DTaP-IPV-HB-PRP~T
Experimental: Group 2: CombAct-HIB™ + OPV
Intervention: Biological: CombAct-HIB®
Active Comparator: Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth)
Intervention: Biological: Engerix B® Pediatric

Publications *

Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68-74.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

622

Completion Date

August 2009

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

0 to 3 day old infants
Mother seronegative for HIV
Born at full term of pregnancy (>= 37 weeks) with a birth weight >= 2.5 kg
Apgar score >7 at 5 or 10 minutes of life
Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

Current or planned participation in another clinical trial during the entire duration of the present trial
Suspected congenital or acquired immunodeficiency
Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
Chronic illness at a stage that could interfere with trial conduct or completion
Blood or blood-derived products received since birth
Any planned vaccination (except BCG and trial vaccinations) from birth to 18 weeks of age
OPV administration at birth
Known maternal history of HIV, HB (HbsAg carrier) or Hepatitis C seropositivity
Thrombocytopenia or bleeding disorder contraindicating IM vaccination
History of seizures
Febrile or acute illness on the day of inclusion.

Gender

Both

Ages

up to 3 Days

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 Number ^ICMJE

NCT00362336

Other Study ID Numbers ^ICMJE

A3L15

Has Data Monitoring Committee

Yes

Responsible Party

Sanofi-Aventis

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Sanofi Pasteur Inc.

Information Provided By

Sanofi-Aventis

Verification Date

September 2011

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

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