Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines. - Tabular View

Tracking Information

First Received Date ^ICMJE

October 15, 2007

Last Updated Date

October 9, 2008

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
Occurrence of local injection site reactions (1M after vacc).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00544271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
SAEs (full study).

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.

Official Title ^ICMJE

Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency & Reactogenicity of DTPa - INFANRIX & dTpa - BOOSTRIX Vaccines Admnd to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR).

Brief Summary

To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diphtheria
Tetanus
Pertussis
Hepatitis A

Intervention ^ICMJE

Biological: INFANRIX
Biological: BOOSTRIX
Biological: HAVRIX

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

Terminated

Enrollment ^ICMJE

720

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female children between and including 18 -20 months of age at the time of the vaccination.
Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
Written informed consent obtained before study entry from the parents or guardians of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.

Gender

Both

Ages

18 Months to 20 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00544271

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

263855/035

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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