MeaslesPhase 3NCT00985166
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
A Phase 3 study testing ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live), Comparator: M-M-R II and Comparator: Varivax in people with Measles and Mumps, run by Merck Sharp & Dohme LLC.
Trial summary
The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- What is being tested?
- ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live), Comparator: M-M-R II and Comparator: Varivax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 801 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to May 2003
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In good health
- Received primary dose of M-M-R II at less than or equal to 12 months of age
- Received primary dose of Varivax at less than or equal to 12 months of age
- Negative history of varicella, zoster, measles, mumps, and rubella
Who cannot join
- history of receiving more than once dose of M-M-R II or Varivax
- Any immune impairment or deficiency
- Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
- Vaccination with an inactive vaccine with in the past 14 days
- Vaccination with a live vaccine within the past 30 days
- Receipt of immune globulin, or blood product in the past 5 months
About this study
Official title: Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.
- Being tested
- ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live), Comparator: M-M-R II, Comparator: Varivax, Comparator: Placebo
- 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.
ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)Biological
Also called ProQuad
A Single 0.5 mL subcutaneous injection at Day 1
Comparator: M-M-R IIBiological
A Single 0.5 mL subcutaneous injection at Day 1
Comparator: VarivaxBiological
A Single 0.5 mL subcutaneous injection at Day 1
Comparator: PlaceboBiological
A Single 0.5 mL subcutaneous placebo injection at Day 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ProQuad + Placebo Receives: Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live); Biological: Comparator: Placebo |
| 2 | Active comparator | M-M-R II + Placebo Receives: Biological: Comparator: M-M-R II; Biological: Comparator: Placebo |
| 3 | Active comparator | M-M-R II + Varivax Receives: Biological: Comparator: M-M-R II; Biological: Comparator: Varivax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Measured: 6 weeks Postvaccination
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Measles
Measured: 6 weeks Postvaccination
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Mumps
Measured: 6 weeks Postvaccination
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Measured: 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 posted28 Sep 2009 (estimated)
- Study startAug 2000
- Primary completionMay 2002
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 801 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
- NCT00985166
- Sponsor's protocol ID
- V221-014
- Other IDs
- 2009_668
- Status last verified
- Jul 2015
- First submitted
- 24 Sep 2009
- Last updated
- 28 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. doi: 10.1542/peds.2005-0092.
PubMed 16452343
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
- ClinicalTrials.gov ID
- NCT00985166
- Acronym / sponsor ID
- V221-014
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- May 2002 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Posted 29 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live), Biological: Comparator: PlaceboProQuad + Placebo |
| 2 | Active comparator | Biological: Comparator: M-M-R II, Biological: Comparator: PlaceboM-M-R II + Placebo |
| 3 | Active comparator | Biological: Comparator: M-M-R II, Biological: Comparator: VarivaxM-M-R II + Varivax |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- In good health
- Received primary dose of M-M-R II at less than or equal to 12 months of age
- Received primary dose of Varivax at less than or equal to 12 months of age
- Negative history of varicella, zoster, measles, mumps, and rubella
Key exclusion criteria (6 listed)
- history of receiving more than once dose of M-M-R II or Varivax
- Any immune impairment or deficiency
- Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
- Vaccination with an inactive vaccine with in the past 14 days
- Vaccination with a live vaccine within the past 30 days
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 |
|---|---|---|
| ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)Also: ProQuadA Single 0.5 mL subcutaneous injection at Day 1 | Biological | 1 |
| Comparator: M-M-R IIA Single 0.5 mL subcutaneous injection at Day 1 | Biological | 2, 3 |
| Comparator: VarivaxA Single 0.5 mL subcutaneous injection at Day 1 | Biological | 3 |
| Comparator: PlaceboA Single 0.5 mL subcutaneous placebo injection at Day 1 | Biological | 1, 2 |
Primary outcome
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Time frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Time frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Measles
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Time frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Mumps
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Time frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16452343Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. doi: 10.1542/peds.2005-0092.
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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 ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live), Comparator: M-M-R II and Comparator: Varivax 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 4 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 28 Jul 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?
Yes. Results are posted in the registry (first posted 29 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer (time frame: 6 weeks Postvaccination). The study lists 4 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 NCT00985166, 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 28 Jul 2015.