Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.

NCT00835237 | Completed Phase 3 Results

• 1 other identifier: 111413
• Study Type: interventional
• Target: 1,332
• Locations: 1 country
• Sites: 24

Brief Summary

This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.

Conditions

Tetanus; Acellular Pertussis; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines

Keywords

Boostrix®; adults

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value

  Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T). Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL) Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL

  One month after vaccination.

• Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration

  Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)

  Before (PRE) and one month after vaccination (POST)

Secondary Outcomes (8)

• Anti-T and Anti-D Antibody Concentrations

  Before (PRE) and one month after vaccination (POST)

• Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off

  One month after vaccination

• Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off

  One month after vaccination

• Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.

  One month after vaccination

• Number of Subjects Reporting Solicited Local Symptoms

  Within the 4-day (Day 0-3) post-vaccination period

Study Arms (2)

Boostrix Group

EXPERIMENTAL

Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)

Biological: Boostrix®

Decavac Group

ACTIVE COMPARATOR

Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Biological: Decavac™

Interventions

Boostrix® BIOLOGICAL

Intramuscular, single dose.

Boostrix Group

Decavac™ BIOLOGICAL

Intramuscular, single dose.

Decavac Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.
• Males or females 65 years of age and older at the time of study entry.
• Free of an acute aggravation of the health status as established by medical history and medical history and clinical examination before entering into the study.
• Written informed consent from all subjects.

You may not qualify if:

• Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
• Administration of a Tdap vaccine at any time prior to study entry.
• History of diphtheria and/or tetanus and/or pertussis disease.
• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
• Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination.
• Planned administration of any vaccine not foreseen by the study protocol up to 30 days following vaccination, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination. Pneumococcal and zoster vaccines can be administered at the discretion of the investigator when the subject comes back at Visit 2.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• History of serious allergic reaction following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.
• History of encephalopathy within seven days of administration of a previous booster dose of pertussis vaccine that is not attributable to another identifiable cause.
• Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.
• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
• Acute disease at the time of vaccination.
• Administration of immunoglobulins and/or any blood products within the three months preceding vaccination, or planned administration during the study period.
• Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

Tucson, Arizona, 85741, United States

Location

GSK Investigational Site

Los Angeles, California, 90057, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Stockbridge, Georgia, 30281, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46254, United States

Location

GSK Investigational Site

Pratt, Kansas, 67124, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Columbia, Maryland, 21045, United States

Location

GSK Investigational Site

Elkridge, Maryland, 21075, United States

Location

GSK Investigational Site

Milford, Massachusetts, 01757, United States

Location

GSK Investigational Site

Stevensville, Michigan, 49127, United States

Location

GSK Investigational Site

High Point, North Carolina, 27262, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Mogadore, Ohio, 44260, United States

Location

GSK Investigational Site

Wadsworth, Ohio, 44281, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

West Jordan, Utah, 84088, United States

Location

GSK Investigational Site

Williamsburg, Virginia, 23185, United States

Location

GSK Investigational Site

Wenatchee, Washington, 98801, United States

Location

Related Publications (2)

• Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix((R))): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. doi: 10.1016/j.vaccine.2011.12.055. Epub 2011 Dec 31.

  PMID: 22212127 BACKGROUND

• Weston WM et al. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Boostrix™): results of a randomized clinical trial. Abstract presented at the 45th National Immunization Conference (NIC). Washington, USA, 28-31 March 2011.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Tetanus; Diphtheria

Interventions

Boostrix; Diphtheria-Tetanus Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: February 17, 2009
• Primary Completion: July 23, 2009
• Study Completion: October 15, 2009
• Last Updated: January 3, 2020
• Results First Posted: August 5, 2010

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (24)