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

This study has been terminated.

First Received on October 15, 2007. Last Updated on September 29, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00544271

Purpose

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.

Condition	Intervention	Phase
Diphtheria Pertussis Hepatitis A Tetanus	Biological: INFANRIX Biological: BOOSTRIX Biological: HAVRIX	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	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).

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis A Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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).

Enrollment:	720
Study Start Date:	May 2003

Intervention Details:

Other Names:

INFANRIX
HAVRIX
BOOSTRIX

Eligibility

Ages Eligible for Study:	18 Months to 20 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544271

Locations

Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00544271 History of Changes
Other Study ID Numbers:	263855/035
Study First Received:	October 15, 2007
Last Updated:	September 29, 2011
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

BOOSTRIX
INFANRIX

Additional relevant MeSH terms:

Diphtheria
Hepatitis
Hepatitis A
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on February 09, 2012