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CompletedNCT00092430Updated Nov 15, 2019

Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)

A Phase 3 interventional study of V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks in Measles, Mumps and Rubella, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 12 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-15.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Sep 2002, registered Sep 2004).
Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
12 Months to 23 Months
Sex
All
01

Study summary

The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.

02

Conditions studied

  • Measles
  • Mumps
  • Rubella
  • Varicella
03

In context

Measles

134 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 1,200 is above the median of 852 across 105 interventional studies indexed under Measles.

Browse Measles studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.

Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 23 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy children 12-23 months of age

Exclusion criteria

Exclusion Criteria:

  • Previously had measles, mumps, rubella, or varicella
  • Compromised immune system
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,200 participants

Interventions

  • BiologicalV221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks
06

What researchers measure

Primary outcomes

  1. Percent of patients demonstrating adequate antibody titers 6 weeks following administration

Secondary outcomes

  1. Geometric mean titers (GMT) 6 weeks post vaccination

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Bernstein HH, Eves K, Campbell K, Black SB, Twiggs JD, Reisinger KS, Conti RM, Flodmark CE, Rombo L, Klopfer S, Schodel F, Hartzel J, Kuter BJ; Refrigerator-Stable Formulation Study Group for ProQuad. Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live). Pediatrics. 2007 Jun;119(6):e1299-305. doi: 10.1542/peds.2006-2283. Epub 2007 May 14. PubMed 17502347 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2002 to primary completion in Jun 2003, 8 months.

Of 16 phase 3 interventional studies under Measles, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 24. This study's 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2004
First posted
Sep 27, 2004
StartActual
Sep 26, 2002
Primary completionActual
Jun 9, 2003
CompletionActual
Jun 9, 2003
Last update
Nov 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00092430
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 27, 2004
Start date
Sep 26, 2002
Primary completion
Jun 9, 2003
Completion
Jun 9, 2003
Last update
Nov 15, 2019

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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