ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00975507
First received: September 10, 2009
Last updated: April 29, 2014
Last verified: April 2014

September 10, 2009
April 29, 2014
March 1998
January 1999   (final data collection date for 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 ] [ Designated as safety issue: No ]
Antibody Response to Varicella at 6 Weeks Postvaccination 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 [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00975507 on ClinicalTrials.gov Archive Site
  • Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline
  • 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 ] [ Designated as safety issue: No ]
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline
  • Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline
  • Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative to Measles at Baseline [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
  • Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
  • Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative to Mumps at Baseline [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
  • Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative to Rubella at Baseline [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Measles
  • Mumps
  • Rubella
  • Varicella
  • Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
    a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
    Other Name: ProQuad™
  • Biological: Comparator: Placebo
    a single 0.5 mL subcutaneous placebo injection at Day 0
  • Biological: Comparator: Varivax
    a single 0.5 mL subcutaneous injection of Varivax at Day 0
  • Biological: Comparator: M-M-R II
    a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
  • Experimental: 1
    ProQuad™ (V221) + Placebo Followed by ProQuad™
    Interventions:
    • Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
    • Biological: Comparator: Placebo
  • Active Comparator: 2
    M-M-R™ II + VARIVAX™
    Interventions:
    • Biological: Comparator: Varivax
    • Biological: Comparator: M-M-R II
Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schödel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
June 1999
January 1999   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
12 Months to 23 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00975507
V221-009, 2009_660
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP