NCT00985153

Brief Summary

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,927

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2000

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, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 9, 2010

Completed
Last Updated

November 23, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

September 25, 2009

Results QC Date

January 13, 2010

Last Update Submit

November 20, 2015

Conditions

MeaslesMumpsRubellaVaricella

Outcome Measures

Primary Outcomes (9)

  • Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL

    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \< 1.25 gpELISA units/mL at Baseline

    6 weeks Postvaccination

  • Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL

    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 120 mIU/mL) to Measles at Baseline

    6 weeks Postvaccination

  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL

    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 Ab units/mL) to Mumps at Baseline

    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

    6 weeks Postvaccination

  • Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to Varicella

    6 weeks Postvaccination

  • Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to Measles.

    6 weeks Postvaccination

  • Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to Mumps.

    6 weeks Postvaccination

  • Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to Rubella

    6 weeks Postvaccination

  • Number of Participants With Serious Vaccine-related CAEs

    Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).

    6 weeks Postvaccination

Study Arms (4)

1

EXPERIMENTAL

ProQuad Lot 1

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

2

EXPERIMENTAL

ProQuad Lot 2

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

3

EXPERIMENTAL

ProQuad Lot 3

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

4

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 at Day 0

Also known as: ProQuad
123
Comparator: VarivaxBIOLOGICAL

A Single 0.5 mL subcutaneous injection at Day 0

4
Comparator: M-M-R IIBIOLOGICAL

A Single 0.5 mL subcutaneous injection at Day 0

4

Eligibility Criteria

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

You may qualify if:

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schodel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22. doi: 10.1097/01.inf.0000220209.35074.0b.

    PMID: 16804432RESULT

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

Limitations and Caveats

One additional subject received M-M-R™ II and ProQuad™ vaccines at the same visit in error; this child was excluded from all immunogenicity and safety summaries.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
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 25, 2009

First Posted

September 28, 2009

Study Start

March 1, 2000

Primary Completion

May 1, 2001

Study Completion

May 1, 2001

Last Updated

November 23, 2015

Results First Posted

February 9, 2010

Record last verified: 2015-11