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

NCT01738477 | Completed Phase 3 Results

• 1 other identifier: 116570
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 20

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).

Conditions

Tetanus; Acellular Pertussis; Diphtheria

Keywords

Booster; Tdap; Immunogenicity; Repeat dose; Safety; BoostrixTM; Persistence

Outcome Measures

Primary Outcomes (2)

• Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).

  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)

  At Month 1

• Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).

  Concentrations were expressed in geometric mean concentrations (GMCs).

  At Month 1

Secondary Outcomes (10)

• Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).

  At Month 0

• Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.

  At Month 0 and Month 1

• Anti-D and Anti-T Antibody Concentrations.

  At Month 0 and Month 1

• Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).

  At Month 0

• Number of Subjects With a Booster Response to Anti-D and Anti-T.

  At Month 1

Study Arms (2)

Boostrix Group 2

EXPERIMENTAL

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

Boostrix Group 1

ACTIVE COMPARATOR

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

Interventions

Boostrix BIOLOGICAL

Single dose intramuscular administration.

Boostrix Group 1; Boostrix Group 2

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Mesa, Arizona, 85213, United States

Location

GSK Investigational Site

Tempe, Arizona, 85283, United States

Location

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

GSK Investigational Site

Fullerton, California, 92835, United States

Location

GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

Location

GSK Investigational Site

Golden, Colorado, 80401, United States

Location

GSK Investigational Site

Norwich, Connecticut, 06360, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32209, United States

Location

GSK Investigational Site

Chicago, Illinois, 60614, United States

Location

GSK Investigational Site

Bardstown, Kentucky, 40004, United States

Location

GSK Investigational Site

Woburn, Massachusetts, 01801, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68131, United States

Location

GSK Investigational Site

East Setauket, New York, 11733, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44109, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16505, United States

Location

GSK Investigational Site

Upper Saint Clair, Pennsylvania, 15241, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84109, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Tetanus; Diphtheria

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 30, 2012
• Study Start: January 31, 2013
• Primary Completion: April 2, 2014
• Study Completion: April 2, 2014
• Last Updated: June 6, 2018
• Results First Posted: December 27, 2017

Record last verified: 2018-05

Locations

US (20)