A Study of ProQuad™ in Healthy Children in Korea (V221-023)

This study has been terminated.
(Study terminated early because of insufficient enrollment before expiration date of the investigational vaccine lot)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00839917
First received: February 6, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
Biological: M-M-R™ II and Varivax™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline

  • Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline

  • Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline

  • Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline


Secondary Outcome Measures:
  • Geometric Mean Titer of Measles Antibodies [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline

  • Geometric Mean Titer of Mumps Antibodies [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline

  • Geometric Mean Titer of Rubella Antibodies [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline

  • Geometric Mean Titer of VZV (gpELISA) Antibodies [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]
    Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline


Other Outcome Measures:
  • Percentage of Participants With Measles-like Rash [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Varicella-like Rash [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Rubella-like Rash [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Zoster-like Rash [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Any Systemic Adverse Experience [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]

    An adverse experience is defined as any unfavorable and unintended change in the

    structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences.


  • Percentage of Participants With Injection-site Adverse Experiences [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.

  • Percentage of Participants With Injection-site Adverse Experiences [ Time Frame: Through 5 days postvaccination ] [ Designated as safety issue: Yes ]
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.

  • Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal) [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ProQuad™ Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
Single administration of 0.5 mL subcutaneous injection
Other Name: V221
Active Comparator: M-M-R™ II and Varivax™ Biological: M-M-R™ II and Varivax™
Single administration of 0.5 mL subcutaneous injection

  Eligibility

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

Inclusion Criteria:

  • Subject is in good health
  • Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion Criteria:

  • Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
  • Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
  • Subject has a history of seizure disorder
  • Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
  • Subject has received an inactivated vaccine within the past 14 days
  • Subject has received a live vaccine within the past 30 days
  • Subject has received immune globulin within the past 5 months
  • Subject has a recent history of fever (within the last 72 hours)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839917

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

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00839917     History of Changes
Other Study ID Numbers: V221-023, 2009_538
Study First Received: February 6, 2009
Results First Received: September 7, 2012
Last Updated: February 11, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Merck Sharp & Dohme Corp.:
Measles
Mumps
Rubella
Varicella

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Parotitis
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014