RubellaPhase 3NCT00406211
Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine
A Phase 3 study testing MMRV, MMR (Priorix®) and Varicella (Varilrix®) in people with Rubella and Varicella, run by GlaxoSmithKline at 41 sites in 2 countries.
Trial summary
Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine… Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- What is being tested?
- MMRV, MMR (Priorix®) and Varicella (Varilrix®)
- How many people
- 398 participants
- Where
- 41 sitesin 2 countries
- Study dates
- Jul 2004to Dec 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 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
- Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
- Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.
Who cannot join
- Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
Germany37 sites
GSK Investigational Site
Altenholz, Schleswig-Holstein, 24161
GSK Investigational Site
Bad Camberg, Hesse, 65520
GSK Investigational Site
Bad Kreuznach, Rhineland-Palatinate, 55543
GSK Investigational Site
Bad Sobernheim, Rhineland-Palatinate, 55566
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821
GSK Investigational Site
Brunsbüttel, Schleswig-Holstein, 25541
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Fulda, Hesse, 36037
GSK Investigational Site
Gau-Algesheim, Rhineland-Palatinate, 55435
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33332
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22089
GSK Investigational Site
Hochheim am Main, Hesse, 65239
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Kirchlengern, North Rhine-Westphalia, 32278
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Marburg/Lahn, Hesse, 35039
GSK Investigational Site
Marktredwitz, Bavaria, 95615
GSK Investigational Site
Münster, North Rhine-Westphalia, 48159
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534
GSK Investigational Site
Nidderau, Hesse, 61130
GSK Investigational Site
Olching, Bavaria, 82140
GSK Investigational Site
Rüsselsheim am Main, Hesse, 65428
GSK Investigational Site
Salzgitter, Lower Saxony, 38226
GSK Investigational Site
Schoeneberg - Kuebelberg, Rhineland-Palatinate, 66901
GSK Investigational Site
Tegernsee, Bavaria, 83684
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Tutzing, Bavaria, 82327
GSK Investigational Site
Wiesbaden, Hesse, 65205
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
Austria4 sites
GSK Investigational Site
Klagenfurt, A-9020
GSK Investigational Site
Neufeld/Leitha, A 2491
GSK Investigational Site
Salzburg, A-5020
GSK Investigational Site
Villach, A-9500
About this study
Official title: Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.
Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany \& Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 \& 3). No new subjects will be enrolled in these follow-up phases of the study.
- Being tested
- MMRV, MMR (Priorix®), Varicella (Varilrix®)
- Keywords
- Rubella, Varicella, Measles, Mumps, Germany, Austria
- Medical subject headings
- Rubella, Chickenpox, Mumps, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMRVBiological
MMR (Priorix®)Biological
Varicella (Varilrix®)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startJul 2004
- Primary completionDec 2004
- Study completionDec 2004
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 RubellaStudies 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
- 398 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
- NCT00406211
- Sponsor's protocol ID
- 208136/039
- Other IDs
- 208136/040, 208136/041
- Status last verified
- Sep 2016
- First submitted
- 1 Dec 2006
- Last updated
- 15 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
Habermehl P, Zepp F, Sänger R, Otto W, Helm K, Meister N, Knuf M, Kindler K, Willems P. Assessment of Varicella Breakthrough Cases One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella Vaccine in the Second Year of Life. Abstract presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.
Knuf M, Faber J, Barth I, Habermehl P. A combination vaccine against measles, mumps, rubella and varicella. Drugs Today (Barc). 2008 Apr;44(4):279-92. doi: 10.1358/dot.2008.44.4.1210755.
PubMed 18536786Knuf M, Zepp F, Helm K, Maurer H, Prieler A, Kieninger-Baum D, Douha M, Willems P. Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Eur J Pediatr. 2012 Mar;171(3):463-70. doi: 10.1007/s00431-011-1569-4. Epub 2011 Sep 21.
PubMed 21935584Zepp F et al. Persistence of Functional Antibodies against Mumps Remains High One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella (MMRV) Vaccine in the Second Year of Life. Presented at 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.
- ClinicalTrials.gov ID
- NCT00406211
- Acronym / sponsor ID
- 208136/039
- Keywords
- Rubella, Varicella, Measles, Mumps, Germany, Austria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 4 Dec 2006 (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.
Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany \& Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 \& 3). No new subjects will be enrolled in these follow-up phases of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
- Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
- Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.
Key exclusion criteria (1 listed)
- Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
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 |
|---|---|---|
| MMRV | Biological | – |
| MMR (Priorix®) | Biological | – |
| Varicella (Varilrix®) | Biological | – |
Primary outcome
Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
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 15 Sep 2016.
- BackgroundHabermehl P, Zepp F, Sänger R, Otto W, Helm K, Meister N, Knuf M, Kindler K, Willems P. Assessment of Varicella Breakthrough Cases One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella Vaccine in the Second Year of Life. Abstract presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.
- Background: PubMed 18536786Knuf M, Faber J, Barth I, Habermehl P. A combination vaccine against measles, mumps, rubella and varicella. Drugs Today (Barc). 2008 Apr;44(4):279-92. doi: 10.1358/dot.2008.44.4.1210755.
- Background: PubMed 21935584Knuf M, Zepp F, Helm K, Maurer H, Prieler A, Kieninger-Baum D, Douha M, Willems P. Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Eur J Pediatr. 2012 Mar;171(3):463-70. doi: 10.1007/s00431-011-1569-4. Epub 2011 Sep 21.
- BackgroundZepp F et al. Persistence of Functional Antibodies against Mumps Remains High One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella (MMRV) Vaccine in the Second Year of Life. Presented at 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.
- 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
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MMRV, MMR (Priorix®) and Varicella (Varilrix®) in people with Rubella and Varicella, run by GlaxoSmithKline at 41 sites in 2 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 3 inclusion and 1 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 15 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 41 sites in Germany, Austria. 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?
Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year. 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?
On the ClinicalTrials.gov record for NCT00406211, 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 15 Sep 2016.