DiphtheriaPhase 3NCT00109330
A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
A Phase 3 study testing Combined diphtheria, tetanus, acellular pertussis vaccine in people with Diphtheria and Tetanus, run by GlaxoSmithKline at 44 sites in United States.
Trial summary
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age). Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Acellular Pertussis
- What is being tested?
- Combined diphtheria, tetanus, acellular pertussis vaccine
- Type of treatment
- Vaccines
- How many people
- 4,116 participants
- Where
- 44 sitesUnited States
- Study dates
- Nov 2002to Apr 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).
Who cannot join
- Use of any other investigational drug or vaccine 30 days preceding study vaccination.
- Chronic administration of immunosuppressants.
- Administration of pre-school DTP vaccine within previous 5 years.
- Administration of Td booster within previous 10 years.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
GSK Investigational Site
Akron, Ohio, 44308-1062
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Boston, Massachusetts, 02130
GSK Investigational Site
Boulder, Colorado, 80304
GSK Investigational Site
Bryan, Texas, 77802
GSK Investigational Site
Centennial, Colorado, 80112
GSK Investigational Site
Chapel Hill, North Carolina, 27514
GSK Investigational Site
Chicago, Illinois, 60614
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Escondido, California, 92021
GSK Investigational Site
Fullerton, California, 92835
GSK Investigational Site
Georgetown, Texas, 78626
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
Kingsport, Tennessee, 37660
GSK Investigational Site
Little Rock, Arkansas, 72202
GSK Investigational Site
Lumberton, North Carolina, 28358
GSK Investigational Site
Mesa, Arizona, 85201
GSK Investigational Site
Middletown, Connecticut, 06457
GSK Investigational Site
Milford, Massachusetts, 01757
GSK Investigational Site
New Bedford, Maine, 2740
GSK Investigational Site
Norfolk, Virginia, 23510
GSK Investigational Site
Norwich, Connecticut, 06360
GSK Investigational Site
Omaha, Nebraska, 68178
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213-2583
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Redondo Beach, California, 90277
GSK Investigational Site
Rochester, New York, 14620
GSK Investigational Site
Rolling Hills Est, California, 90274
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Sellersville, Pennsylvania, 18960
GSK Investigational Site
Stony Brook, New York, 11794
GSK Investigational Site
Tempe, Arizona, 85282
GSK Investigational Site
Temple, Texas, 76508
GSK Investigational Site
Torrance, California, 90502
GSK Investigational Site
University Heights, Ohio, 44118
GSK Investigational Site
West Jordan, Utah, 84084
GSK Investigational Site
Whitehouse Station, New Jersey, 08889
GSK Investigational Site
Woburn, Massachusetts, 01801
GSK Investigational Site
Yorba Linda, California, 92886
About this study
Official title: A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).
Read the detailed description
A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Being tested
- Combined diphtheria, tetanus, acellular pertussis vaccine
- Keywords
- Prevention of Diphtheria, Tetanus, Pertussis
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined diphtheria, tetanus, acellular pertussis vaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2005 (estimated)
- Study startNov 2002
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies 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
- Single blind
- Enrolment
- 4,116 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
- NCT00109330
- Sponsor's protocol ID
- 776423/001
- Status last verified
- Sep 2016
- First submitted
- 27 Apr 2005
- Last updated
- 9 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)
- ClinicalTrials.gov ID
- NCT00109330
- Acronym / sponsor ID
- 776423/001
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Keywords
- Prevention of Diphtheria, Tetanus, Pertussis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,116 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 27 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).
Detailed description
A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).
Key exclusion criteria (4 listed)
- Use of any other investigational drug or vaccine 30 days preceding study vaccination.
- Chronic administration of immunosuppressants.
- Administration of pre-school DTP vaccine within previous 5 years.
- Administration of Td booster within previous 10 years.
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 |
|---|---|---|
| Combined diphtheria, tetanus, acellular pertussis vaccine | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- 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. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Diphtheria
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A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
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
44 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 Combined diphtheria, tetanus, acellular pertussis vaccine in people with Diphtheria and Tetanus, run by GlaxoSmithKline at 44 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 1 inclusion and 4 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 9 Sep 2016.