Clinical trial NCT01245049: Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children
Official title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acellular Pertussis
Poliomyelitis
Tetanus
Diphtheria
Keywords: MMR
dTpa-IPV
Boostrix Polio
Repevax
Priorix
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 387
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.
* 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.

Primary outcomes:
measure: Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens
timeFrame: At Month 1, one month after the booster vaccination
measure: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
timeFrame: At Month 1, one month after the booster vaccination
measure: Anti-Polio Virus Type 1, 2 and 3 Antibody Titers
timeFrame: At Month 1, one month after the booster vaccination
Secondary outcomes:
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seropositive Subjects for Anti-measles Antibody
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seropositive Subjects for Anti-mumps Antibody
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seropositive Subjects for Anti-rubella Antibody
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: At Month 0, before the booster vaccination
measure: Anti-mumps Antibody Concentrations
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-measles Antibody Concentrations
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-rubella Antibody Concentrations
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Anti-Polio Type 1, 2 and 3 Antibody Titers
timeFrame: At Month 0, before the booster vaccination
measure: Number of Subjects With a Booster Response to PT, FHA and PRN Antigens
timeFrame: At Month 1, one month after the booster vaccination
measure: Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens
timeFrame: At Month 1, one month after the booster vaccination
measure: Number of Seroconverted Subjects for Anti-measles
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Seroconverted Subjects for Anti-mumps
timeFrame: Before (Month 0) and one month after (Month 1) the booster vaccination
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after booster vaccination
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after booster vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) follow-up period after booster vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (From Day 0 to Month 1)
Other outcomes:
Locations:
city: St Austell
country: United Kingdom
facility: GSK Investigational Site
state: Cornwall
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
state: Hampshire
city: Axbridge
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Taunton
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Atherstone
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Bangor
country: United Kingdom
facility: GSK Investigational Site
city: Bolton, Nr Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Crumpsall, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Exeter
country: United Kingdom
facility: GSK Investigational Site
city: Lancashire
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Randalstown
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Marlow R, Kuriyakose S, Mesaros N, Han HH, Tomlinson R, Faust SN, Snape MD, Pollard AJ, Finn A. A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK. Vaccine. 2018 Apr 19;36(17):2300-2306. doi: 10.1016/j.vaccine.2018.03.021. Epub 2018 Mar 22.