MeaslesPhase 2NCT00109278
A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
A Phase 2 study testing V205C, measles, mumps, and rubella virus vaccine live and Comparator: Measles, Mumps, and Rubella Virus Vaccine Live in people with Measles, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin). Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Measles
- What is being tested?
- V205C, measles, mumps, and rubella virus vaccine live and Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
- Type of treatment
- Vaccines
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to May 2005
- 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 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
- Previous receipt of measles, mumps, rubella and/or varicella vaccine.
- Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
- Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
- History of seizures (convulsions)
- Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
- A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F [37.5° C]).
About this study
Official title: A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age
The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).
Read the detailed description
The duration of treatment is 6 weeks.
- Conditions
- Measles
- Being tested
- V205C, measles, mumps, and rubella virus vaccine live, Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
- Keywords
- Prevention of Measles
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V205C, measles, mumps, and rubella virus vaccine liveBiological
Comparator: Measles, Mumps, and Rubella Virus Vaccine LiveBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response rate to measles at 6 weeks postvaccination
Secondary outcomes (1)
Geometric mean titers to measles by ELISA at 6 weeks postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2005
- Study completionMay 2005
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,100 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
- NCT00109278
- Sponsor's protocol ID
- V205C-010
- Other IDs
- 2005_016
- Status last verified
- Mar 2017
- First submitted
- 26 Apr 2005
- Last updated
- 15 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age
- ClinicalTrials.gov ID
- NCT00109278
- Acronym / sponsor ID
- V205C-010
- Conditions
- Measles
- Keywords
- Prevention of Measles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 26 Apr 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.
The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).
Detailed description
The duration of treatment is 6 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
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 (6 listed)
- Previous receipt of measles, mumps, rubella and/or varicella vaccine.
- Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
- Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
- History of seizures (convulsions)
- Allergies to any component of the vaccine, including sorbitol, gelatin, or 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 |
|---|---|---|
| V205C, measles, mumps, and rubella virus vaccine live | Biological | – |
| Comparator: Measles, Mumps, and Rubella Virus Vaccine Live | Biological | – |
Primary outcome
Antibody response rate to measles at 6 weeks postvaccination
1 secondary outcome
Geometric mean titers to measles by ELISA at 6 weeks 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 15 Mar 2017.
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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 2 study testing V205C, measles, mumps, and rubella virus vaccine live and Comparator: Measles, Mumps, and Rubella Virus Vaccine Live in people with Measles, 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 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 15 Mar 2017. 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 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?
Antibody response rate to measles at 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 15 Mar 2017.