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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01245049
First received: November 18, 2010
Last updated: October 17, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Acellular Pertussis
Poliomyelitis
Tetanus
Diphtheria
Biological: Boostrix PolioTM
Biological: RepevaxTM
Biological: PriorixTM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to the components of the study vaccines. [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to the components of the study vaccines. [ Time Frame: Prior to and one month after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of Solicited local and general symptoms. [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of Unsolicited adverse events. [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of Serious adverse events. [ Time Frame: From the booster dose up to study end (Day 0 to Month 1). ] [ Designated as safety issue: No ]

Enrollment: 387
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects receiving one booster dose each of Boostrix Polio and Priorix vaccines.
Biological: Boostrix PolioTM
Single dose, intramuscular administration.
Biological: PriorixTM
Single dose, intramuscular or subcutaneous administration.
Active Comparator: Group B
Subjects receiving one booster dose each of Repevax and Priorix vaccines.
Biological: RepevaxTM
Single dose, intramuscular administration.
Biological: PriorixTM
Single dose, intramuscular or subcutaneous administration.

  Eligibility

Ages Eligible for Study:   3 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245049

Locations
United Kingdom
GSK Investigational Site
St Austell, Cornwall, United Kingdom, PL26 7RL
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
GSK Investigational Site
Axbridge, Somerset, United Kingdom, BS26 2BJ
GSK Investigational Site
Taunton, Somerset, United Kingdom, TA1 1XQ
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU
GSK Investigational Site
Bangor, United Kingdom, BT19 1PP
GSK Investigational Site
Bolton, Nr Manchester, United Kingdom, BL3 6TL
GSK Investigational Site
Bristol, United Kingdom, BS2 8AE
GSK Investigational Site
Crumpsall, Manchester, United Kingdom, M8 9JT
GSK Investigational Site
Exeter, United Kingdom, EX2 5DW
GSK Investigational Site
Lancashire, United Kingdom, BL1 6AP
GSK Investigational Site
Oxford, United Kingdom, OX3 7LJ
GSK Investigational Site
Randalstown, United Kingdom, BT41 3AE
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01245049     History of Changes
Other Study ID Numbers: 111763
Study First Received: November 18, 2010
Last Updated: October 17, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
MMR
dTpa-IPV
Boostrix Polio
Repevax
Priorix

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014