NCT00975507

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 1998

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1999

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1999

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 10, 2010

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

10 months

First QC Date

September 10, 2009

Results QC Date

September 23, 2009

Last Update Submit

October 5, 2015

Conditions

MeaslesMumpsRubellaVaricella

Outcome Measures

Primary Outcomes (1)

  • 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

    6 weeks Postvaccination

Secondary Outcomes (4)

  • Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL

    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

    6 weeks Postvaccination

  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL

    6 weeks Postvaccination

  • Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL

    6 weeks Postvaccination

Study Arms (2)

1

EXPERIMENTAL

ProQuad™ (V221) + Placebo Followed by ProQuad™

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveBiological: Comparator: Placebo

2

ACTIVE COMPARATOR

M-M-R™ II + VARIVAX™

Biological: Comparator: VarivaxBiological: Comparator: M-M-R II

Interventions

Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveBIOLOGICAL

a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90

Also known as: ProQuad™
1
Comparator: PlaceboBIOLOGICAL

a single 0.5 mL subcutaneous placebo injection at Day 0

1
Comparator: VarivaxBIOLOGICAL

a single 0.5 mL subcutaneous injection of Varivax at Day 0

2
Comparator: M-M-R IIBIOLOGICAL

a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

2

Eligibility Criteria

Age12 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • In good health
  • Negative clinical history of varicella, shingles, measles, mumps, and rubella

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16094217BACKGROUND

MeSH Terms

Conditions

MeaslesMumpsRubellaChickenpox

Interventions

measles, mumps, rubella, varicella vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae InfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

March 1, 1998

Primary Completion

January 1, 1999

Study Completion

June 1, 1999

Last Updated

October 6, 2015

Results First Posted

February 10, 2010

Record last verified: 2015-10