Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323959
First received: March 24, 2011
Last updated: November 14, 2013
Last verified: July 2012
  Purpose

This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another booster dose of BoostrixTM Polio.


Condition Intervention Phase
Acellular Pertussis
Poliomyelitis
Diphtheria
Tetanus
Biological: BoostrixTM Polio
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of GSK Biologicals' Boostrix™ Polio in Healthy Adults, 10 Years After a Booster Vaccination

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to booster vaccination. [ Time Frame: One month (Month 1) after a booster dose of BoostrixTM Polio vaccine ] [ Designated as safety issue: No ]
  • Immune persistence after the booster dose given in the study NCT01277705 [ Time Frame: Before (Day 0) a booster dose of BoostrixTM Polio vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to booster vaccination. [ Time Frame: One month (Month 1) after the booster dose of BoostrixTM Polio vaccine ] [ 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 (Day 0) up to study end (Month 1) ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not applicable
Biological: BoostrixTM Polio
Single dose, intramuscular administration.
Experimental: Group B
Not applicable
Biological: BoostrixTM Polio
Single dose, intramuscular administration.
Experimental: Group C
Not applicable
Biological: BoostrixTM Polio
Single dose, intramuscular administration.

Detailed Description:

This protocol posting has been updated following protocol amendment 1, dated 03 June 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Male or female subjects who have received vaccine in study NCT01277705.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study and receive the booster vaccine, if the subject:

    • practices/has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • agrees to continue adequate contraception during the entire booster epoch.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the 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 dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period.
  • 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.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Group C.
  • History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Occurrence of any of the following adverse event after a previous administration of a DTP vaccine:

    • Hypersensitivity reaction to any component of the vaccine,
    • encephalopathy of unknown aetiology occurring within seven 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.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Acute disease and/or fever at the time of enrolment.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  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: NCT01323959

Locations
France
GSK Investigational Site
Derval, France, 44590
GSK Investigational Site
La Chapelle Basse Mer, France, 44450
GSK Investigational Site
La Riche, France, 37250
GSK Investigational Site
Le Temple De Bretagne, France, 44360
GSK Investigational Site
Nantes, France, 44300
GSK Investigational Site
Tours, France, 37000
GSK Investigational Site
Tours, France, 37200
Germany
GSK Investigational Site
Deggendorf, Bayern, Germany, 94469
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
GSK Investigational Site
Muenchen, Bayern, Germany, 80337
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
GSK Investigational Site
Selbitz, Bayern, Germany, 95152
GSK Investigational Site
Vilshofen, Bayern, Germany, 94474
GSK Investigational Site
Weilheim, Bayern, Germany, 82362
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323959     History of Changes
Other Study ID Numbers: 113060
Study First Received: March 24, 2011
Last Updated: November 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by GlaxoSmithKline:
BoostrixTM Polio
dTpa-IPV
booster

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 21, 2014