MeaslesPhase 3NCT00975507
ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
A Phase 3 study testing Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Varivax and Comparator: M-M-R II in people with Measles and Mumps, run by Merck Sharp & Dohme LLC.
Trial summary
This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- What is being tested?
- Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Varivax and Comparator: M-M-R II
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Mar 1998to Jun 1999
- 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 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In good health
- Negative clinical history of varicella, shingles, measles, mumps, and rubella
Who cannot join
- Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
- 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
- Immune globulin or any blood product administered in the past 3 months
About this study
Official title: A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children
This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.
- Being tested
- Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Placebo, Comparator: Varivax, Comparator: M-M-R II
- 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.
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveBiological
Also called ProQuad™
a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
Comparator: PlaceboBiological
a single 0.5 mL subcutaneous placebo injection at Day 0
Comparator: VarivaxBiological
a single 0.5 mL subcutaneous injection of Varivax at Day 0
Comparator: M-M-R IIBiological
a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ProQuad™ (V221) + Placebo Followed by ProQuad™ Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Biological: Comparator: Placebo |
| 2 | Active comparator | M-M-R™ II + VARIVAX™ Receives: Biological: Comparator: Varivax; Biological: Comparator: M-M-R II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline
Measured: 6 weeks Postvaccination
Secondary outcomes (4)
Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline
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 posted11 Sep 2009 (estimated)
- Study startMar 1998
- Primary completionJan 1999
- Study completionJun 1999
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
- 480 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
- NCT00975507
- Sponsor's protocol ID
- V221-009
- Other IDs
- 2009_660
- Status last verified
- Oct 2015
- First submitted
- 10 Sep 2009
- Last updated
- 6 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schodel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. doi: 10.1097/01.inf.0000172902.25009.a1.
PubMed 16094217
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children
- ClinicalTrials.gov ID
- NCT00975507
- Acronym / sponsor ID
- V221-009
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 1998
- Primary completion
- Jan 1999 (actual)
- Study completion
- Jun 1999 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Posted 10 Feb 2010
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 Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Biological: Comparator: PlaceboProQuad™ (V221) + Placebo Followed by ProQuad™ |
| 2 | Active comparator | Biological: Comparator: Varivax, Biological: Comparator: M-M-R IIM-M-R™ II + VARIVAX™ |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- In good health
- Negative clinical history of varicella, shingles, measles, mumps, and rubella
Key exclusion criteria (6 listed)
- Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
- 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 |
|---|---|---|
| Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveAlso: ProQuad™a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90 | Biological | 1 |
| Comparator: Placeboa single 0.5 mL subcutaneous placebo injection at Day 0 | Biological | 1 |
| Comparator: Varivaxa single 0.5 mL subcutaneous injection of Varivax at Day 0 | Biological | 2 |
| Comparator: M-M-R IIa single 0.5 mL subcutaneous injection of M-M-R II at Day 0 | Biological | 2 |
Primary outcome
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
Time frame: 6 weeks Postvaccination
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline
4 secondary outcomes
Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL
Time frame: 6 weeks Postvaccination
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
Time frame: 6 weeks Postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL
Time frame: 6 weeks Postvaccination
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Time frame: 6 weeks Postvaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16094217Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schodel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. doi: 10.1097/01.inf.0000172902.25009.a1.
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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 Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Varivax and Comparator: M-M-R II 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 2 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 6 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?
Yes. Results are posted in the registry (first posted 10 Feb 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?
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline (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?
On the ClinicalTrials.gov record for NCT00975507, 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 6 Oct 2015.