MeaslesPhase 3NCT00351923
Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes
A Phase 3 study testing MeMuRu-OKA (study vaccine) in people with Measles and Mumps, run by GlaxoSmithKline at 20 sites in Germany.
Trial summary
This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route. Read more about this study
- Who is it for?
- Ages 11 to 22 monthsHealthy volunteers can take part
- What is being tested?
- MeMuRu-OKA (study vaccine)
- Type of treatment
- Vaccines
- How many people
- 330 participants
- Where
- 20 sitesGermany
- Study dates
- Mar 2006to Dec 2006
- 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 22 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children must be healthy and have a birth weight > 2000 g to participate
Who cannot join
- confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
- Children must have received one dose (but not more) of MMR and of varicella 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 within 30 days before vaccination.
- Children must not have had measles, mumps, rubella or varicella/zoster, 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
20 sites in 1 country.
20 sites in 1 country
Germany20 sites
GSK Investigational Site
Bad Kreuznach, Rhineland-Palatinate, 55543
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357
GSK Investigational Site
Bretten, Baden-Wurttemberg, 75015
GSK Investigational Site
Eschwege, Hesse, 37269
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Giessen, Hesse, 35390
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76189
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55127
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
About this study
Official title: Open, Multicenter, Randomised, Controlled Phase IIIb Study Evaluating the Immunogenicity and Safety of Subcutaneous Versus Alternative Administration Route of Combined MeMuRu-OKA Vaccine to Healthy Children Aged 11 to 21 Months.
This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.
- Being tested
- MeMuRu-OKA (study vaccine)
- Medical subject headings
- Measles, Mumps, Rubella, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeMuRu-OKA (study vaccine)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rates after vaccination
Secondary outcomes (1)
Antibody titres; 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 posted13 Jul 2006 (estimated)
- Study startMar 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies 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
- 330 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351923
- Sponsor's protocol ID
- 106670
- Status last verified
- Oct 2008
- First submitted
- 12 Jul 2006
- Last updated
- 13 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicenter, Randomised, Controlled Phase IIIb Study Evaluating the Immunogenicity and Safety of Subcutaneous Versus Alternative Administration Route of Combined MeMuRu-OKA Vaccine to Healthy Children Aged 11 to 21 Months.
- ClinicalTrials.gov ID
- NCT00351923
- Acronym / sponsor ID
- 106670
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 13 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.
This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 11 to 22 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children must be healthy and have a birth weight > 2000 g to participate
Key exclusion criteria (6 listed)
- confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
- Children must have received one dose (but not more) of MMR and of varicella 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 within 30 days before vaccination.
- Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start.
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 vaccine) | Biological | – |
Primary outcome
Seroconversion rates after vaccination
1 secondary outcome
Antibody titres; 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 13 Oct 2008.
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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
20 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 MeMuRu-OKA (study vaccine) in people with Measles and Mumps, run by GlaxoSmithKline at 20 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 6 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 13 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Seroconversion rates 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 13 Oct 2008.