Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children

GlaxoSmithKline1 site in 1 country387 target enrollmentApril 1, 2011

ConditionsAcellular Pertussis Poliomyelitis Tetanus Diphtheria

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Acellular Pertussis
Sponsor: GlaxoSmithKline
Enrollment: 387
Locations: 1
Primary Endpoint: Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Registry

clinicaltrials.gov

Start Date

April 1, 2011

End Date

April 2, 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
•A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).
•Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK).
•Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.
•Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

•Child in care.
•Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
•Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.
•Previous measles, mumps and/or rubella second dose vaccination.
•Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.
•Known exposure to measles, mumps and/or rubella within 30 days prior to study start.
•Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.

Outcomes

Primary Outcomes

Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens

Time Frame: At Month 1, one month after the booster vaccination

Booster response was defined as: For initially seronegative subjects \[i.e. pre-vaccination concentration below (\<) cut-off value of 0.1 international units per milliliter (IU/mL)\] antibody concentrations at least four times the assay cut-off \[post vaccination concentration greater than or equal to (≥) 0.4 IU/ml\]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Time Frame: At Month 1, one month after the booster vaccination

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Anti-Polio Virus Type 1, 2 and 3 Antibody Titers

Time Frame: At Month 1, one month after the booster vaccination

Antibody titers were presented as geometric mean titers (GMTs).

Secondary Outcomes

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)(Before (Month 0) and one month after (Month 1) the booster vaccination)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN(Before (Month 0) and one month after (Month 1) the booster vaccination)
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3(Before (Month 0) and one month after (Month 1) the booster vaccination)
Number of Seropositive Subjects for Anti-mumps Antibody(Before (Month 0) and one month after (Month 1) the booster vaccination)
Number of Seropositive Subjects for Anti-rubella Antibody(Before (Month 0) and one month after (Month 1) the booster vaccination)
Number of Seropositive Subjects for Anti-measles Antibody(Before (Month 0) and one month after (Month 1) the booster vaccination)
Anti-D and Anti-T Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(At Month 0, before the booster vaccination)
Anti-mumps Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
Anti-measles Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
Anti-rubella Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
Anti-Polio Type 1, 2 and 3 Antibody Titers(At Month 0, before the booster vaccination)
Number of Subjects With a Booster Response to PT, FHA and PRN Antigens(At Month 1, one month after the booster vaccination)
Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens(At Month 1, one month after the booster vaccination)
Number of Seroconverted Subjects for Anti-measles(Before (Month 0) and one month after (Month 1) the booster vaccination)
Number of Seroconverted Subjects for Anti-mumps(Before (Month 0) and one month after (Month 1) the booster vaccination)
Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after booster vaccination)
Number of Subjects With Any Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after booster vaccination)
Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) follow-up period after booster vaccination)
Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (From Day 0 to Month 1))