TetanusPhase 3NCT01738477
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults
A Phase 3 study testing Boostrix in people with Tetanus and Acellular Pertussis, run by GlaxoSmithKline at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Acellular Pertussis, Diphtheria
- What is being tested?
- Boostrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 20 sitesUnited States
- Study dates
- 31 Jan 2013to 2 Apr 2014
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Chicago, Illinois, 60614
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
East Setauket, New York, 11733
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fullerton, California, 92835
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Jacksonville, Florida, 32209
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Mesa, Arizona, 85213
GSK Investigational Site
Norwich, Connecticut, 06360
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Tempe, Arizona, 85283
GSK Investigational Site
Upper Saint Clair, Pennsylvania, 15241
GSK Investigational Site
Woburn, Massachusetts, 01801
About this study
Official title: Evaluation of Immunogenicity and Safety of GSK Biologicals' Tdap Booster Vaccine (Boostrix™) in Young Adults, Administered 10 Years After Previous Tdap Boosting
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).
Read the 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.
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria
- Being tested
- Boostrix
- Keywords
- Booster, Tdap, Immunogenicity, Repeat dose, Safety, BoostrixTM, Persistence
- Medical subject headings
- Tetanus, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoostrixBiological
Single dose intramuscular administration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Boostrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: At Month 1
Secondary outcomes (10)
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)
Measured: At Month 0
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.
The cut-off of the assay was ≥ 1.0 IU/mL.
Measured: At Month 0 and Month 1
Anti-D and Anti-T Antibody Concentrations.
Concentrations were expressed as GMCs.
Measured: At Month 0 and 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).
Measured: At Month 0
Number of Subjects With a Booster Response to Anti-D and Anti-T.
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.
Measured: At Month 1
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
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.
Measured: At Month 1.
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.
Measured: During the 4 days (Day 0 - 3) follow-up period after vaccination.
Number of Subjects With Solicited General Symptoms.
The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.
Measured: During the 4 days (Day 0 - 3) follow-up period after vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs).
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.
Measured: During the 31 days (Day 0 - 30) after vaccination.
Number of Subjects With Serious Adverse Events (SAEs).
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.
Measured: From Day 0 to 31 days post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study start31 Jan 2013
- Primary completion2 Apr 2014
- Study completion2 Apr 2014
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738477
- Sponsor's protocol ID
- 116570
- Status last verified
- May 2018
- First submitted
- 21 Nov 2012
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunogenicity and Safety of GSK Biologicals' Tdap Booster Vaccine (Boostrix™) in Young Adults, Administered 10 Years After Previous Tdap Boosting
- ClinicalTrials.gov ID
- NCT01738477
- Acronym / sponsor ID
- 116570
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria
- Keywords
- Booster, Tdap, Immunogenicity, Repeat dose, Safety, BoostrixTM, Persistence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2013 (actual)
- Primary completion
- 2 Apr 2014 (actual)
- Study completion
- 2 Apr 2014 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 27 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boostrix Group 2 | Experimental | Biological: BoostrixHealthy 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. |
| Boostrix Group 1 | Active comparator | Biological: BoostrixHealthy 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. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| BoostrixSingle dose intramuscular administration. | Biological | Boostrix Group 1, Boostrix Group 2 |
Primary outcome
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)
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).
10 secondary outcomes
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
Time frame: At Month 0
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.
Time frame: At Month 0 and Month 1
Anti-D and Anti-T Antibody Concentrations.
Time frame: At Month 0 and Month 1
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).
Time frame: At Month 0
Number of Subjects With a Booster Response to Anti-D and Anti-T.
Time frame: At Month 1
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Month 1.
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 4 days (Day 0 - 3) follow-up period after vaccination.
Number of Subjects With Solicited General Symptoms.
Time frame: During the 4 days (Day 0 - 3) follow-up period after vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs).
Time frame: During the 31 days (Day 0 - 30) after vaccination.
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From Day 0 to 31 days post-vaccination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
20 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 in people with Tetanus and Acellular Pertussis, run by GlaxoSmithKline at 20 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 10 inclusion and 17 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 27 Dec 2017). 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 Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). (time frame: At Month 1). 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?
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 6 Jun 2018.