ClinicalTrials.gg
CompletedNCT00092391Updated Oct 23, 2015

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 interventional study of Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live and Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) in Measles, Mumps and Rubella, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-23.

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

Phase
Phase 3
Study type
Interventional
Enrollment
1,997
Allocation
Randomized
Ages
12 Months to 18 Months
Sex
All
01

Study 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.

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 1,997 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.

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

04

Who can participate

Ages eligible
12 Months to 18 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 to 18 months of age

Exclusion criteria

Exclusion Criteria:

  • History or prior exposure to measles, mumps, rubella or varicella
  • History of anaphylactoid reactions or to any component of the vaccine, including gelatin and neomycin
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
1,997 participants (actual)

Study arms

  • Active comparator
    Control Group

    M-M-R(TM) II at current release potency

    Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live · Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)

  • Experimental
    Mumps Expiry Group 1

    M-M-R(TM) II at intermediate expiry potency

    Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live · Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)

  • Experimental
    Mumps Expiry Group 2

    M-M-R(TM) II at expiry potency

    Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live · Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)

Interventions

  • BiologicalComparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live

    0.5 mL subcutaneous injection of one of three sub-lots on Day 0

  • BiologicalComparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)

    0.5 mL subcutaneous injection on Day 0

06

What researchers measure

Primary outcomes

  1. Neutralizing antibodies to mumps at 6 weeks postvaccination

    Time frame: 6 weeks postvaccination

Secondary outcomes

  1. Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination

    Time frame: 6 weeks and 1 year postvaccination

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 1999, a primary completion of Jul 2001 and a completion of Jul 2001. It does not say whether these dates are actual or estimated.

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

Registered
Sep 22, 2004
First posted
Sep 27, 2004
Start
Feb 1999
Primary completionActual
Jul 2001
CompletionActual
Jul 2001
Last update
Oct 23, 2015
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 Oct 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00092391
Responsible party
Sponsor
First posted
Sep 27, 2004
Start date
Feb 1999
Primary completion
Jul 2001
Completion
Jul 2001
Last update
Oct 23, 2015

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 Oct 2015. You cannot join it, but the record below documents what was studied.

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