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

Study Overview
=================
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.

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

Conditions
-----------------
Acellular Pertussis, Tetanus, Diphtheria

Intervention / Treatment
-----------------
* Biological: INFANRIX
* Biological: BOOSTRIX
* Biological: HAVRIX


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 20 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: INFANRIX|nan|
|Biological: BOOSTRIX|nan|
|Biological: HAVRIX|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BOOSTRIX, INFANRIX