ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01738477
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : December 27, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Tetanus Acellular Pertussis Diphtheria Biological: Boostrix Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 31, 2013
Actual Primary Completion Date : April 2, 2014
Actual Study Completion Date : April 2, 2014


Arm Intervention/treatment
Experimental: Boostrix Group 2
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Biological: Boostrix
Single dose intramuscular administration.

Active Comparator: Boostrix Group 1
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Biological: Boostrix
Single dose intramuscular administration.




Primary Outcome Measures :
  1. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). [ Time Frame: At Month 1 ]
    A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

  2. Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). [ Time Frame: At Month 1 ]
    Concentrations were expressed in geometric mean concentrations (GMCs).


Secondary Outcome Measures :
  1. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). [ Time Frame: At Month 0 ]
    A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

  2. Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off. [ Time Frame: At Month 0 and Month 1 ]
    The cut-off of the assay was ≥ 1.0 IU/mL.

  3. Anti-D and Anti-T Antibody Concentrations. [ Time Frame: At Month 0 and Month 1 ]
    Concentrations were expressed as GMCs.

  4. Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). [ Time Frame: At Month 0 ]
    Concentrations were expressed in geometric mean concentrations (GMCs).

  5. Number of Subjects With a Booster Response to Anti-D and Anti-T. [ Time Frame: At Month 1 ]

    Booster response to anti-D and anti-T antigens was defined as:

    • for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination,
    • for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination.

  6. Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. [ Time Frame: At Month 1. ]

    Booster response to pertussis antigens was defined as:

    • for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination;
    • for initially seropositive subjects with anti-body concentration < four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination;
    • for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination.

  7. Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 4 days (Day 0 - 3) follow-up period after vaccination. ]
    The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.

  8. Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 4 days (Day 0 - 3) follow-up period after vaccination. ]
    The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.

  9. Number of Subjects With Unsolicited Adverse Events (AEs). [ Time Frame: During the 31 days (Day 0 - 30) after vaccination. ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

  10. Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: From Day 0 to 31 days post-vaccination. ]
    SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738477


Locations
United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85213
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
East Setauket, New York, United States, 11733
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44109
GSK Investigational Site
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
GSK Investigational Site
Upper Saint 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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01738477     History of Changes
Other Study ID Numbers: 116570
First Posted: November 30, 2012    Key Record Dates
Results First Posted: December 27, 2017
Last Update Posted: June 5, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs