ProQuad Dose Selection Study (V221-011)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00986232
First received: September 25, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Biological: Comparator: M-M-R II
Biological: Comparator: PUVV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units


Secondary Outcome Measures:
  • Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles 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 in participants 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 in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline

  • Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) [ Time Frame: 6 weeks Postvaccination Visit 1 or Visit 2 ] [ Designated as safety issue: Yes ]
    Participants 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).

  • Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)

  • Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)

  • Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)

  • Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)


Enrollment: 1551
Study Start Date: April 1999
Study Completion Date: September 2000
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ProQuad (low dose)
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
Other Name: ProQuad
Experimental: 2
ProQuad (middle dose)
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
Other Name: ProQuad
Experimental: 3
ProQuad (high dose)
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
Other Name: ProQuad
Active Comparator: 4
M-M-R II + PUVV
Biological: Comparator: M-M-R II
A single 0.5 mL subcutaneous injection at Day 0
Biological: Comparator: PUVV
A single 0.5 mL subcutaneous injection at Day 0

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986232

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00986232     History of Changes
Other Study ID Numbers: V221-011, 2009_667
Study First Received: September 25, 2009
Results First Received: January 25, 2010
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Measles
Herpes Zoster
Chickenpox
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on October 16, 2014