VaricellaPhase 2NCT00353288
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
A Phase 2 study testing MeMuRu-OKA (study vacc) in people with Varicella and Rubella, run by GlaxoSmithKline at 39 sites in 3 countries.
Trial summary
As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience… Read more about this study
- Who is it for?
- Ages 15 months to 6 yearsHealthy volunteers can take part
- What is being tested?
- MeMuRu-OKA (study vacc)
- How many people
- 446 participants
- Where
- 39 sitesin 3 countries
- Study dates
- Mar 2006to Nov 2006
- Phase
- Phase 2
- 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 15 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children must be healthy to participate
Who cannot join
- Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
- They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
- Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination.
- Children must not have been vaccinated against varicella.
- They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start.
- New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
Germany23 sites
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357
GSK Investigational Site
Cham, Bavaria, 93413
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
Flensburg, Schleswig-Holstein, 24944
GSK Investigational Site
Herford, North Rhine-Westphalia, 32049
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Kempten (Allgäu), Bavaria, 87435
GSK Investigational Site
Kirchzarten, Baden-Wurttemberg, 79199
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534
GSK Investigational Site
Olching, Bavaria, 82140
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Schwieberdingen, Baden-Wurttemberg, 71701
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Tettnang, Baden-Wurttemberg, 88069
GSK Investigational Site
Werneck, Bavaria, 97440
France12 sites
GSK Investigational Site
Ancenis, 44150
GSK Investigational Site
Boulogne, 92100
GSK Investigational Site
Dax, 40100
GSK Investigational Site
Draguignan, 83300
GSK Investigational Site
Essey-lès-Nancy, 54270
GSK Investigational Site
Laon, 02000
GSK Investigational Site
Le Havre, 76600
GSK Investigational Site
Lingolsheim, 67380
GSK Investigational Site
Lyon, 69437
GSK Investigational Site
Nice, 06300
GSK Investigational Site
Paris, 75019
GSK Investigational Site
Villeneuve Les Avignons, 30400
Italy4 sites
GSK Investigational Site
Cagliari, Sardinia, 09127
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 20122
GSK Investigational Site
Sassari, Sardinia, 07100
About this study
Official title: Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine
As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.
- Being tested
- MeMuRu-OKA (study vacc), MMR, Varicella vacc (control)
- Medical subject headings
- Chickenpox, Rubella, Measles, Mumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeMuRu-OKA (study vacc)Biological
MMR, Varicella vacc (control)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Varicella seroconversion and MMR titres at 42-56 days after first vaccination
Secondary outcomes (1)
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2006
- Study completionNov 2006
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 VaricellaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 446 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
- NCT00353288
- Sponsor's protocol ID
- 105908
- Status last verified
- Oct 2016
- First submitted
- 17 Jul 2006
- Last updated
- 7 Oct 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
Gillet Y, Steri GC, Behre U, Arsene JP, Lanse X, Helm K, Esposito S, Meister N, Desole MG, Douha M, Willems P. Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. Vaccine. 2009 Jan 14;27(3):446-53. doi: 10.1016/j.vaccine.2008.10.064. Epub 2008 Nov 11.
PubMed 19007835
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine
- ClinicalTrials.gov ID
- NCT00353288
- Acronym / sponsor ID
- 105908
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 18 Jul 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.
As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children must be healthy to participate
Key exclusion criteria (7 listed)
- Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
- They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
- Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination.
- Children must not have been vaccinated against varicella.
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 |
|---|---|---|
| MeMuRu-OKA (study vacc) | Biological | – |
| MMR, Varicella vacc (control) | Biological | – |
Primary outcome
Varicella seroconversion and MMR titres at 42-56 days after first vaccination
1 secondary outcome
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
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 7 Oct 2016.
- Background: PubMed 19007835Gillet Y, Steri GC, Behre U, Arsene JP, Lanse X, Helm K, Esposito S, Meister N, Desole MG, Douha M, Willems P. Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. Vaccine. 2009 Jan 14;27(3):446-53. doi: 10.1016/j.vaccine.2008.10.064. Epub 2008 Nov 11.
- 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
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MeMuRu-OKA (study vacc) in people with Varicella and Rubella, run by GlaxoSmithKline at 39 sites in 3 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 7 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 7 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 39 sites in Germany, France, Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Varicella seroconversion and MMR titres at 42-56 days after first 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 NCT00353288, 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 7 Oct 2016.