MumpsPhase 4NCT00126997
Immunogenicity and Safety of Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
A Phase 4 study testing Measles, Mumps, Rubella and Chickenpox (live vaccine) in people with Mumps and Rubella, run by GlaxoSmithKline at 54 sites in 4 countries.
Trial summary
This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life. Read more about this study
- Who is it for?
- Ages 11 to 21 monthsHealthy volunteers can take part
- What is being tested?
- Measles, Mumps, Rubella and Chickenpox (live vaccine)
- Type of treatment
- Vaccines
- How many people
- 1,439 participants
- Where
- 54 sitesin 4 countries
- Study dates
- May 2005to Nov 2005
- Phase
- Phase 4
- 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 11 to 21 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.
Who cannot join
- History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
- Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
Trial locations and contacts
54 sites in 4 countries.
54 sites in 4 countries
Germany37 sites
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549
GSK Investigational Site
Bayreuth, Bavaria, 95444
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Bobingen, Bavaria, 86399
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44866
GSK Investigational Site
Cham, Bavaria, 93413
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44329
GSK Investigational Site
Eschwege, Hesse, 37269
GSK Investigational Site
Espelkamp, North Rhine-Westphalia, 32339
GSK Investigational Site
Frankfurt am Main, Hesse, 60389
GSK Investigational Site
Fulda, Hesse, 36037
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33332
GSK Investigational Site
Hille, North Rhine-Westphalia, 32479
GSK Investigational Site
Kempten (Allgäu), Bavaria, 87435
GSK Investigational Site
Kirchlengern, North Rhine-Westphalia, 32278
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41061
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41236
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Munich, Bavaria, 81735
GSK Investigational Site
Münster, North Rhine-Westphalia, 48159
GSK Investigational Site
Nidderau, Hesse, 61130
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Nuremberg, Bavaria, 90473
GSK Investigational Site
Olching, Bavaria, 82140
GSK Investigational Site
Salzgitter, Lower Saxony, 38226
GSK Investigational Site
Tegernsee, Bavaria, 83684
GSK Investigational Site
Tutzing, Bavaria, 82327
GSK Investigational Site
Veitshöchheim, Bavaria, 97209
GSK Investigational Site
Wesseling, North Rhine-Westphalia, 50389
GSK Investigational Site
Wiesbaden, Hesse, 65205
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302
Finland7 sites
GSK Investigational Site
Espoo, 02100
GSK Investigational Site
Lahti, 15140
GSK Investigational Site
Oulu, 90100
GSK Investigational Site
Pori, 28120
GSK Investigational Site
Tampere, 33200
GSK Investigational Site
Turku, 20520
GSK Investigational Site
Vantaa, 01300
Greece5 sites
GSK Investigational Site
Arta, 471 00
GSK Investigational Site
Athens, 11527
GSK Investigational Site
Komotini, 69100
GSK Investigational Site
Rhodes, 851 00
GSK Investigational Site
Thessaloniki, 54636
Poland5 sites
GSK Investigational Site
Bydgoszcz, 85-021
GSK Investigational Site
Krakow, 31-202
GSK Investigational Site
Poznan, 61-709
GSK Investigational Site
Siemianowice Śląskie, 41-103
GSK Investigational Site
Trzebnica, 55-100
About this study
Official title: Blinded, Randomised Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-mumps-rubella-varicella Candidate Vaccine When Given to Healthy Children in Their Second Year of Life
This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.
- Being tested
- Measles, Mumps, Rubella and Chickenpox (live vaccine)
- Keywords
- Prophylaxis measles, mumps, rubella and chickenpox
- Medical subject headings
- Mumps, Rubella, Measles, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles, Mumps, Rubella and Chickenpox (live vaccine)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody levels after vaccination.
Secondary outcomes (1)
Safety of the study vaccines.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startMay 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MumpsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,439 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
- NCT00126997
- Sponsor's protocol ID
- 104020
- Status last verified
- Sep 2016
- First submitted
- 4 Aug 2005
- Last updated
- 21 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 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded, Randomised Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-mumps-rubella-varicella Candidate Vaccine When Given to Healthy Children in Their Second Year of Life
- ClinicalTrials.gov ID
- NCT00126997
- Acronym / sponsor ID
- 104020
- Keywords
- Prophylaxis measles, mumps, rubella and chickenpox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,439 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 5 Aug 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 is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 11 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.
Key exclusion criteria (2 listed)
- History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
- Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each 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 |
|---|---|---|
| Measles, Mumps, Rubella and Chickenpox (live vaccine) | Biological | – |
Primary outcome
Antibody levels after vaccination.
1 secondary outcome
Safety of the study vaccines.
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 21 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.
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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
54 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Measles, Mumps, Rubella and Chickenpox (live vaccine) in people with Mumps and Rubella, run by GlaxoSmithKline at 54 sites in 4 countries.
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 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 21 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 54 sites in Germany, Finland, Greece, Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Antibody levels after vaccination.. 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 21 Sep 2016.