MumpsPhase 3NCT00127023
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
A Phase 3 study testing Measles, Mumps, Rubella and Chickenpox (live vaccine) in people with Mumps and Varicella, run by GlaxoSmithKline at 85 sites in Germany.
Trial summary
This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate 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
- 944 participants
- Where
- 85 sitesGermany
- Study dates
- May 2005to Nov 2005
- 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 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
85 sites in 1 country.
85 sites in 1 country
Germany85 sites
GSK Investigational Site
Augsburg, Bavaria, 86163
GSK Investigational Site
Bad Kreuznach, Rhineland-Palatinate, 55543
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348
GSK Investigational Site
Berlin, State of Berlin, 10315
GSK Investigational Site
Berlin, State of Berlin, 10967
GSK Investigational Site
Berlin, State of Berlin, 10999
GSK Investigational Site
Berlin, State of Berlin, 12627
GSK Investigational Site
Berlin, State of Berlin, 12679
GSK Investigational Site
Berlin, State of Berlin, 13055
GSK Investigational Site
Berlin, State of Berlin, 13355
GSK Investigational Site
Berlin, State of Berlin, 14197
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Bischofswerda, Saxony, 01877
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44866
GSK Investigational Site
Bodenheim, Rhineland-Palatinate, 55294
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821
GSK Investigational Site
Bretten, Baden-Wurttemberg, 75015
GSK Investigational Site
Brunsbüttel, Schleswig-Holstein, 25541
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Döbeln, Saxony, 04720
GSK Investigational Site
Dresden, Saxony, 01169
GSK Investigational Site
Ehingen, Baden-Wurttemberg, 89584
GSK Investigational Site
Eppelheim, Baden-Wurttemberg, 69214
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Fulda, Hesse, 36037
GSK Investigational Site
Gerolstein, Rhineland-Palatinate, 54568
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22089
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22143
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22307
GSK Investigational Site
Harrislee, Schleswig-Holstein, 24955
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579
GSK Investigational Site
Herbolzheim, Baden-Wurttemberg, 79336
GSK Investigational Site
Hille, North Rhine-Westphalia, 32479
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76185
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Kirchzarten, Baden-Wurttemberg, 79199
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798
GSK Investigational Site
Leipzig, Saxony, 04178
GSK Investigational Site
Leipzig, Saxony, 04317
GSK Investigational Site
Ludwigsburg, Baden-Wurttemberg, 71634
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67059
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68309
GSK Investigational Site
Marbach, Baden-Wurttemberg, 71672
GSK Investigational Site
Marktheidenfeld, Bavaria, 97828
GSK Investigational Site
Mölln, Schleswig-Holstein, 23879
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534
GSK Investigational Site
Niebüll, Schleswig-Holstein, 25899
GSK Investigational Site
Nuremberg, Bavaria, 90473
GSK Investigational Site
Oberhausen, North Rhine-Westphalia, 46145
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, 71720
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77656
GSK Investigational Site
Pfinztal, Baden-Wurttemberg, 76327
GSK Investigational Site
Roding, Bavaria, 93426
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18059
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18146
GSK Investigational Site
Salzgitter, Lower Saxony, 38226
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Stollberg, Saxony, 09366
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941
GSK Investigational Site
Tettnang, Baden-Wurttemberg, 88069
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, 17192
GSK Investigational Site
Weimar, Thuringia, 99425
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
About this study
Official title: Blinded, Randomised, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Combined Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children in Their Second Year of Life
This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.
Read the detailed description
Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.
- Being tested
- Measles, Mumps, Rubella and Chickenpox (live vaccine)
- Keywords
- Prophylaxis measles, mumps, rubella and chickenpox
- Medical subject headings
- Mumps, Chickenpox, Rubella, Measles
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
Also called Measles, Mumps, Rubella and Chickenpox (live vaccine)
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
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 944 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
- NCT00127023
- Sponsor's protocol ID
- 104389
- 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.
Publications
Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22.
PubMed 18600190Schuster V et al. Immunogenicity of a Refrigerator-Stable Tetravalent MMRV Vaccine after One and Two Doses. Presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 3-5 May 2006.
Schuster V et al. Tolerability of a Refrigerator-Stable Tetravalent MMRV vaccine after One and Two Doses. Presented at the 12th International Congress on Infectious Diseases (ICID), Lisbon, Portugal, 15-18 June 2006.
Dhillon S, Curran MP. Live attenuated measles, mumps, rubella, and varicella zoster virus vaccine (Priorix-Tetra). Paediatr Drugs. 2008;10(5):337-47. doi: 10.2165/00148581-200810050-00007.
PubMed 18754700
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, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Combined Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children in Their Second Year of Life
- ClinicalTrials.gov ID
- NCT00127023
- Acronym / sponsor ID
- 104389
- Keywords
- Prophylaxis measles, mumps, rubella and chickenpox
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 944 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2005
- 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 evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.
Detailed description
Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.
Study design
- Primary purpose
- Prevention
- 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)Also: 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.
- Background: PubMed 18600190Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22.
- BackgroundSchuster V et al. Immunogenicity of a Refrigerator-Stable Tetravalent MMRV Vaccine after One and Two Doses. Presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 3-5 May 2006.
- BackgroundSchuster V et al. Tolerability of a Refrigerator-Stable Tetravalent MMRV vaccine after One and Two Doses. Presented at the 12th International Congress on Infectious Diseases (ICID), Lisbon, Portugal, 15-18 June 2006.
- Background: PubMed 18754700Dhillon S, Curran MP. Live attenuated measles, mumps, rubella, and varicella zoster virus vaccine (Priorix-Tetra). Paediatr Drugs. 2008;10(5):337-47. doi: 10.2165/00148581-200810050-00007.
- 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
85 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 Measles, Mumps, Rubella and Chickenpox (live vaccine) in people with Mumps and Varicella, run by GlaxoSmithKline at 85 sites in Germany.
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 85 sites in Germany. 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?
Antibody levels after vaccination.. 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 NCT00127023, which also lists 4 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 21 Sep 2016.