Evaluation of Boostrix™10 Years After Previous Booster Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01147900
First received: May 20, 2010
Last updated: October 24, 2013
Last verified: August 2013
  Purpose

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate study (see reference).


Condition Intervention Phase
Acellular Pertussis
Tetanus
Diphtheria
Biological: Boostrix™
Biological: Boostrix™-US formulation
Phase 4

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroprotected Subjects Against Diphtheria and Tetanus [ Time Frame: At Year 8.5 ] [ Designated as safety issue: No ]
    A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

  • Concentrations for Anti-D and Anti-T Antibodies. [ Time Frame: At Year 8.5 ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.

  • Number of Seroprotected Subjects Against Diphtheria and Tetanus. [ Time Frame: At Year 10 ] [ Designated as safety issue: No ]
    A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

  • Concentrations for Anti-D and Anti-T Antibodies. [ Time Frame: At Year 10 ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

  • Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies. [ Time Frame: At Year 8.5 ] [ Designated as safety issue: No ]
    A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  • Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies. [ Time Frame: At Year 8.5 ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.

  • Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies. [ Time Frame: At Year 10 ] [ Designated as safety issue: No ]
    A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  • Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies. [ Time Frame: At Year 10 ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

  • Number of Seroprotected Subjects Against Diphtheria and Tetanus [ Time Frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) ] [ Designated as safety issue: No ]
    A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

  • Concentrations for Anti-D and Anti-T Antibodies. [ Time Frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.

  • Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies. [ Time Frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) ] [ Designated as safety issue: No ]
    A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).

  • Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies. [ Time Frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

  • Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens. [ Time Frame: At 1 month post Year 10 booster vaccination ] [ Designated as safety issue: No ]

    A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination.

    A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL.



Secondary Outcome Measures:
  • Number of Subjects With Any Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
    Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.

  • Number of Subjects With Any Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 31-day (Days 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
    An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.

  • Number of Subjects With Any Serious Adverse Events (SAEs). [ Time Frame: At Year 8.5 ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..

  • Number of Subjects With Any Serious Adverse Events (SAEs). [ Time Frame: From Year 8.5 up to study end (one month post Year 10 booster vaccination) ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 180
Study Start Date: June 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boostrix-REF Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Biological: Boostrix™
Intramuscular, single dose
Experimental: Boostrix-US Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Biological: Boostrix™-US formulation
Intramuscular, single dose
Experimental: Boostrix-INV Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Biological: Boostrix™
Intramuscular, single dose

Detailed Description:

All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present study.

  Eligibility

Ages Eligible for Study:   18 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/029.
  • Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.
  • Healthy subjects as established by medical history and clinical examination.
  • Female subjects of non-childbearing potential may receive the booster vaccine.
  • Female subjects of childbearing potential may 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:

Exclusion criteria to be checked at study entry:

  • Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029.
  • History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
  • 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.
  • 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 (axillary temperature) 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 three days of vaccination.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Additional exclusion criteria to be checked for subjects before the booster vaccination administration:

  • 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 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.
  • 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.

    • Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147900

Locations
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01147900     History of Changes
Other Study ID Numbers: 113055
Study First Received: May 20, 2010
Results First Received: April 25, 2013
Last Updated: October 24, 2013
Health Authority: Belgium: Direction Générale de la Protection de la Santé Publique Médicaments

Keywords provided by GlaxoSmithKline:
Immune persistence
Boostrix
dTpa booster study

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on April 15, 2014