MeaslesPhase 3NCT00092391
A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
A Phase 3 study testing Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live and Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) in people with Measles and Mumps, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- What is being tested?
- Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live and Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,997 participants
- Where
- No sites listed yet
- Study dates
- Feb 1999to Jul 2001
- 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
- Healthy children 12 to 18 months of age
Who cannot join
- History or prior exposure to measles, mumps, rubella or varicella
- History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin
About this study
Official title: A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age
The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.
- Being tested
- Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live, Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
- 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.
Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine liveBiological
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)Biological
0.5 mL subcutaneous injection on Day 0
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | M-M-R(TM) II at current release potency Receives: Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live; Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) |
| Mumps Expiry Group 1 | Experimental | M-M-R(TM) II at intermediate expiry potency Receives: Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live; Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) |
| Mumps Expiry Group 2 | Experimental | M-M-R(TM) II at expiry potency Receives: Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live; Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibodies to mumps at 6 weeks postvaccination
Measured: 6 weeks postvaccination
Secondary outcomes (1)
Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination
Measured: 6 weeks and 1 year postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2004 (estimated)
- Study startFeb 1999
- Primary completionJul 2001
- Study completionJul 2001
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 Merck Sharp & Dohme LLCThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00092391
- Sponsor's protocol ID
- V205C-007
- Other IDs
- 2004_073
- Status last verified
- Oct 2015
- First submitted
- 22 Sep 2004
- Last updated
- 23 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age
- ClinicalTrials.gov ID
- NCT00092391
- Acronym / sponsor ID
- V205C-007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,997 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 1999
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 27 Sep 2004 (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.
The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live, Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)M-M-R(TM) II at current release potency |
| Mumps Expiry Group 1 | Experimental | Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live, Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)M-M-R(TM) II at intermediate expiry potency |
| Mumps Expiry Group 2 | Experimental | Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live, Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)M-M-R(TM) II at expiry potency |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children 12 to 18 months of age
Key exclusion criteria (2 listed)
- History or prior exposure to measles, mumps, rubella or varicella
- History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin
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 |
|---|---|---|
| Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live0.5 mL subcutaneous injection of one of three sub-lots on Day 0 | Biological | Control Group, Mumps Expiry Group 1, Mumps Expiry Group 2 |
| Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)0.5 mL subcutaneous injection on Day 0 | Biological | Control Group, Mumps Expiry Group 1, Mumps Expiry Group 2 |
Primary outcome
Neutralizing antibodies to mumps at 6 weeks postvaccination
Time frame: 6 weeks postvaccination
1 secondary outcome
Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination
Time frame: 6 weeks and 1 year postvaccination
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 23 Oct 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live and Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) in people with Measles and Mumps, run by Merck Sharp & Dohme LLC.
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 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Neutralizing antibodies to mumps at 6 weeks postvaccination (time frame: 6 weeks postvaccination). 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 23 Oct 2015.