DiphtheriaPhase 3NCT00452686
Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine
A Phase 3 study testing Boostrix and Chinese DT vaccine in people with Diphtheria and Acellular Pertussis, run by GlaxoSmithKline at 1 site in China.
Trial summary
This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Acellular Pertussis, Tetanus
- What is being tested?
- Boostrix and Chinese DT vaccine
- Type of treatment
- Vaccines
- How many people
- 660 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to May 2007
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female between, and including, 6-8 years of age at the time of vaccination,
- Written informed consent obtained from the parent or guardian of the subject,
Who cannot join
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
- Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years
This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Being tested
- Boostrix, Chinese DT vaccine
- Keywords
- Chinese DT vaccin
- Medical subject headings
- Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoostrixBiological
Chinese DT vaccineBiological
Also called Boostrix
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.
Secondary outcomes (1)
Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startMar 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 660 participants
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
- NCT00452686
- Sponsor's protocol ID
- 108638
- Status last verified
- Oct 2016
- First submitted
- 26 Mar 2007
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- 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.
Publications
Zhu F, Zhang S, Hou Q, Zhang Y, Xu Y, Ma X, Lu X, Pan H, Chen D, Ramakrishnan G, Zhao R, Tang H, Van Der Meeren O, Bock HL. Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix()). Hum Vaccin. 2010 Mar 3;6(3):10503. doi: 10.4161/hv.6.3.10503. Epub 2010 Mar 3.
PubMed 20215881
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years
- ClinicalTrials.gov ID
- NCT00452686
- Acronym / sponsor ID
- 108638
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Keywords
- Chinese DT vaccin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- May 2007 (actual)
- First posted
- 27 Mar 2007 (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 immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- A male or female between, and including, 6-8 years of age at the time of vaccination,
- Written informed consent obtained from the parent or guardian of the subject,
Key exclusion criteria (2 listed)
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
- Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.
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 | Biological | – |
| Chinese DT vaccineAlso: Boostrix | Biological | – |
Primary outcome
Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.
1 secondary outcome
Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs
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 28 Oct 2016.
- Background: PubMed 20215881Zhu F, Zhang S, Hou Q, Zhang Y, Xu Y, Ma X, Lu X, Pan H, Chen D, Ramakrishnan G, Zhao R, Tang H, Van Der Meeren O, Bock HL. Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix()). Hum Vaccin. 2010 Mar 3;6(3):10503. doi: 10.4161/hv.6.3.10503. Epub 2010 Mar 3.
- 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 I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
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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)
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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
1 site 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 Chinese DT vaccine in people with Diphtheria and Acellular Pertussis, run by GlaxoSmithKline at 1 site in China.
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 2 inclusion and 2 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does the primary outcome measure?
Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.. 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 NCT00452686, which also lists 1 linked publication.
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 28 Oct 2016.