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Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01738477
First received: November 21, 2012
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00109330).


Condition Intervention Phase
Tetanus
Acellular Pertussis
Diphtheria
Biological: Boostrix
Phase 3

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 Immunogenicity and Safety of GSK Biologicals' Tdap Booster Vaccine (Boostrix™) in Young Adults, Administered 10 Years After Previous Tdap Boosting

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccine in terms of seroprotection/geometric mean antibody concentrations (GMCs). [ Time Frame: One month after vaccination with BoostrixTM (Month 1). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccine in terms of antibody concentrations, seropositivity and vaccine response. [ Time Frame: Before (Day 0) and one month after vaccination with BoostrixTM (Month 1). ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: During the 4 days (Day 0 - 3) follow-up period after vaccination with BoostrixTM. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events. [ Time Frame: During the 31 days (Day 0 - 30) after vaccination with BoostrixTM. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: From Day 0 to 31 days post-vaccination. ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Tdap
Subjects who had received Boostrix™ vaccine in study NCT00109330 and will receive a second dose of Boostrix™ vaccine.
Biological: Boostrix
Single dose intramuscular administration.
Active Comparator: Group Td
Subjects who had received control Td vaccine in study NCT00109330 and will receive the first dose of Boostrix™ vaccine.
Biological: Boostrix
Single dose intramuscular administration.

Detailed Description:

Subjects were previously vaccinated with either Boostrix or a control Td vaccine in study NCT00109330. Only subjects who were part of the primary study will be invited to participate in this study. All subjects will receive a single dose of Boostrix at Visit 1 (Day 0) and subjects will be observed till Visit 2 (Day 30) for safety in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period). A blood sample will be collected from all subjects before vaccination (Visit 1) and one month after vaccination (Visit 2) for antibodies estimation.

This summary has been updated following Protocol amendment 2 dated 03 October 2013. The protocol is being amended to facilitate enrolment by:

  • - Extending the window period for re-vaccination from ± 6 months to ± 300 days from the Year 10 time point.
  • - Extending the recruitment period from 6 months to 14 months. The format of non-inferiority criterion of the first co-primary objective has been updated to keep it aligned with the format of non-inferiority criterion of the second co-primary objective.
  Eligibility

Ages Eligible for Study:   19 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
  • Subjects who have received a dose of Tdap or Td vaccines 10 years (+/-300 days) back, in study NCT00109330.
  • 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.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the vaccine dose.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . For corticosteroids, this will mean prednisone (≥ 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 31 days after the dose of vaccine, with the exception of Influenza vaccine which is allowed throughout the 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 vaccine/product (pharmaceutical product or device).
  • Previous vaccination against diphtheria, tetanus or pertussis since the last dose received in the Study NCT00109330.
  • History of diphtheria, tetanus or pertussis diseases following the receipt of booster dose in the Study NCT00109330.
  • Severe allergic reaction (e.g. anaphylaxis) after previous administration of any tetanus toxoid, diphtheria toxoid, or pertussis-antigen containing vaccines, or any component of Boostrix.
  • Hypersensitivity to latex.
  • Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of unknown etiology occurring within 7 days following previous vaccination with pertussis-containing vaccine.
  • History of any neurological disorders or seizures.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 99.5°F for oral, axillary or tympanic route, or ≥ 100.4°F for rectal route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions up to 1 month post-vaccination.
  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: NCT01738477

Locations
United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85282
GSK Investigational Site
Tempe, Arizona, United States, 85283
United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
GSK Investigational Site
Fullerton, California, United States, 92835
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
United States, Colorado
GSK Investigational Site
Golden, Colorado, United States, 80401
United States, Connecticut
GSK Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60614
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Massachusetts
GSK Investigational Site
Woburn, Massachusetts, United States, 01801
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, New York
GSK Investigational Site
Stony Brook, New York, United States, 11794-8111
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44121
GSK Investigational Site
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
GSK Investigational Site
Upper St. Clair, Pennsylvania, United States, 15241
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01738477     History of Changes
Other Study ID Numbers: 116570
Study First Received: November 21, 2012
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Tdap
Safety
Booster
Immunogenicity
Persistence
BoostrixTM
Repeat dose

ClinicalTrials.gov processed this record on November 19, 2014