TetanusPhase 3NCT00835237

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

A Phase 3 study testing Boostrix® and Decavac™ in people with Tetanus and Acellular Pertussis, run by GlaxoSmithKline at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Tetanus, Acellular Pertussis, Diphtheria
What is being tested?: Boostrix® and Decavac™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,332 participants
Where: 24 sitesUnited States
Study dates: 17 Feb 2009to 15 Oct 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Columbia, Maryland, 21045
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Elkridge, Maryland, 21075
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
High Point, North Carolina, 27262
GSK Investigational Site
Indianapolis, Indiana, 46254
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Los Angeles, California, 90057
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Milford, Massachusetts, 01757
GSK Investigational Site
Mogadore, Ohio, 44260
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Pratt, Kansas, 67124
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Tucson, Arizona, 85741
GSK Investigational Site
Wadsworth, Ohio, 44281
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
West Jordan, Utah, 84088
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Williamsburg, Virginia, 23185
GSK Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: Evaluation of GSK Biologicals' Boostrix® Vaccine When Compared With Decavac™ in Adults Aged 65 Years or Older.

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
Being tested: Boostrix®, Decavac™
Keywords: Boostrix®, adults
Medical subject headings: Tetanus, Diphtheria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Boostrix®Biological
Intramuscular, single dose.
Decavac™Biological
Intramuscular, single dose.

Study groups in NCT00835237
Study group	Role	What they receive
Boostrix Group	Experimental	Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) Receives: Biological: Boostrix®
Decavac Group	Active comparator	Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine) Receives: Biological: Decavac™

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

Anti-T and Anti-D Antibody Concentrations
Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
Measured: 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
Booster response defined as :
For initially seronegative subjects (< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination.
For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Measured: One month after vaccination
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Booster response defined as :
For initially seronegative subjects (< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination.
For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration.
Measured: 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.
Vaccine response using alternative definitions defined as:
For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination.
For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration.
Measured: One month after vaccination
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Measured: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever
Measured: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is 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.
Measured: Within the 31-day (Day 0-30) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: From the vaccination up to Day 182

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 200915 Oct 2009

First posted3 Feb 2009 (estimated)
Study start17 Feb 2009
Primary completion23 Jul 2009
Study completion15 Oct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TetanusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,332 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00835237
Sponsor's protocol ID: 111413
Status last verified: Dec 2019
First submitted: 2 Feb 2009
Last updated: 3 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

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.
PubMed 22212127
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of GSK Biologicals' Boostrix® Vaccine When Compared With Decavac™ in Adults Aged 65 Years or Older.
ClinicalTrials.gov ID: NCT00835237
Acronym / sponsor ID: 111413
Conditions: Tetanus, Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines
Keywords: Boostrix®, adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,332 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Feb 2009 (actual)
Primary completion: 23 Jul 2009 (actual)
Study completion: 15 Oct 2009 (actual)
First posted: 3 Feb 2009 (estimated)
Results: Posted 5 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Boostrix Group	Experimental	Biological: Boostrix®Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group	Active comparator	Biological: Decavac™Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Boostrix®Intramuscular, single dose.	Biological	Boostrix Group
Decavac™Intramuscular, single dose.	Biological	Decavac Group

Primary outcome

Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Time frame: One month after vaccination.
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
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Time frame: Before (PRE) and one month after vaccination (POST)
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)

8 secondary outcomes

Anti-T and Anti-D Antibody Concentrations
Time frame: 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
Time frame: One month after vaccination
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Time frame: 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.
Time frame: One month after vaccination
Number of Subjects Reporting Solicited Local Symptoms
Time frame: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Solicited General Symptoms
Time frame: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Time frame: Within the 31-day (Day 0-30) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
Time frame: From the vaccination up to Day 182

Results and safety

Results posted to the registry on 5 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Boostrix Group	887	881
Decavac Group	445	445

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

Time frame: One month after vaccination.. Number. Unit: subjects

Measure	Boostrix Group n = 864	Decavac Group n = 439
Anti-D (≥ 0.1 IU/mL) (N= 859;432)	729	374
Anti-T (≥ 0.1 IU/mL) (N= 864;439)	836	428
Anti-T (≥ 1.0 IU/mL) (N= 864;439)	767	395

Population analysed: Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results

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

Time frame: Before (PRE) and one month after vaccination (POST). Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Boostrix Group n = 865	Decavac Group n = 439
Anti-PT (PRE) (N=859;433)	6.6 (6.1 to 7.1)	6.5 (5.8 to 7.2)
Anti-PT (POST) (N=852;431)	49.1 (44.9 to 53.7)	6.4 (5.8 to 7.1)
Anti-FHA (PRE) (N=848;430)	50.2 (46.2 to 54.5)	44.3 (39.5 to 49.5)
Anti-FHA (POST) (N=835;428)	689.0 (638.8 to 743.1)	44.4 (39.7 to 49.7)
Anti-PRN (PRE) (N=864;439)	8.1 (7.4 to 8.8)	7.8 (6.9 to 8.8)
Anti-PRN (POST) (N=865;439)	104.2 (91.3 to 118.9)	7.7 (6.8 to 8.7)

Population analysed: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boostrix Group	37 of 887 (4.2%)	351 of 887 (39.6%)	Not reported
Decavac Group	10 of 445 (2.2%)	202 of 445 (45.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22212127Weston 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.
BackgroundWeston 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Boostrix® and Decavac™ in people with Tetanus and Acellular Pertussis, run by GlaxoSmithKline at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value (time frame: One month after vaccination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00835237, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.