Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

GlaxoSmithKline387 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

387

Conditions

Acellular Pertussis Poliomyelitis Tetanus Diphtheria

Interventions

Boostrix PolioTMBIOLOGICAL

Single dose, intramuscular administration.

RepevaxTMBIOLOGICAL

Single dose, intramuscular administration.

PriorixTMBIOLOGICAL

Single dose, intramuscular or subcutaneous administration.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 4 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period. * Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation. * Occurrence of any of the following adverse events after a previous administration of a DTP vaccine: * Hypersensitivity reaction to any component of the vaccine; * Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine; * Fever \>= 40°C within 48 hours of vaccination, not due to another identifiable cause; * Collapse or shock-like state within 48 hours of vaccination; * Convulsions with or without fever, occurring within 3 days of vaccination. * Acute disease and/or fever at the time of enrolment or within 24 hours of study vaccine administration.

Locations (13)

GSK Investigational Site

St Austell, Cornwall, United Kingdom

GSK Investigational Site

Southampton, Hampshire, United Kingdom

GSK Investigational Site

Axbridge, Somerset, United Kingdom

Outcomes

Primary Outcomes

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

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.

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

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

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

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

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

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

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

Secondary Outcomes

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)

A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN

A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Data from ClinicalTrials.gov

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GSK Investigational Site

Taunton, Somerset, United Kingdom

GSK Investigational Site

Atherstone, Warwickshire, United Kingdom

GSK Investigational Site

Bangor, United Kingdom

GSK Investigational Site

Bolton, Nr Manchester, United Kingdom

GSK Investigational Site

Bristol, United Kingdom

GSK Investigational Site

Crumpsall, Manchester, United Kingdom

GSK Investigational Site

Exeter, United Kingdom

...and 3 more locations

Number of Seroprotected Subjects Against Polio Type 1, 2 and 3

A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of Seropositive Subjects for Anti-measles Antibody

A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of Seropositive Subjects for Anti-mumps Antibody

A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of Seropositive Subjects for Anti-rubella Antibody

A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-D and Anti-T Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

Time frame: At Month 0, before the booster vaccination

Anti-mumps Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-measles Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-rubella Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-Polio Type 1, 2 and 3 Antibody Titers

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

Time frame: At Month 0, before the booster vaccination

Number of Subjects With a Booster Response to PT, FHA and PRN Antigens

Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration \< 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects (with pre-vaccination concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. For initially seropositive subjects (with pre-vaccination concentration ≥ 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration.

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

Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens

Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.

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

Number of Seroconverted Subjects for Anti-measles

Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative \[with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)\].

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of Seroconverted Subjects for Anti-mumps

Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative \[with antibody concentrations ≥ 231 units per millilitre (U/mL)\].

Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of Subjects With Any Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination

Number of Subjects With Any Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

Time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: During the 31-day (Days 0-30) follow-up period after booster vaccination

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: During the entire study period (From Day 0 to Month 1)