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

NCT ID: NCT01245049

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-01
• Study Completion Date: 2012-04-02

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.

Conditions

Acellular Pertussis; Poliomyelitis; Tetanus; Diphtheria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BOOSTRIX POLIO GROUP

Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.

Group Type: EXPERIMENTAL

Boostrix PolioTM

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration.

PriorixTM

Intervention Type: BIOLOGICAL

Single dose, intramuscular or subcutaneous administration.

REPEVAX GROUP

Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.

Group Type: ACTIVE_COMPARATOR

RepevaxTM

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration.

PriorixTM

Intervention Type: BIOLOGICAL

Single dose, intramuscular or subcutaneous administration.

Interventions

Boostrix PolioTM

Single dose, intramuscular administration.

Intervention Type: BIOLOGICAL

RepevaxTM

Single dose, intramuscular administration.

Intervention Type: BIOLOGICAL

PriorixTM

Single dose, intramuscular or subcutaneous administration.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

St Austell, Cornwall, United Kingdom

GSK Investigational Site

Southampton, Hampshire, United Kingdom

GSK Investigational Site

Axbridge, Somerset, United Kingdom

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

GSK Investigational Site

Lancashire, , United Kingdom

GSK Investigational Site

Oxford, , United Kingdom

GSK Investigational Site

Randalstown, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29576304 (View on PubMed)

Related Links

https://clinicalstudydatarequest.com

IPD for this study will be made available via the Clinical Study Data Request site.

Other Identifiers

111763

Identifier Type: -

Identifier Source: org_study_id