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Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00985153
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : February 9, 2010
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Measles Mumps Rubella Varicella Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Biological: Comparator: Varivax Biological: Comparator: M-M-R II Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3927 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children
Study Start Date : March 2000
Primary Completion Date : May 2001
Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
ProQuad Lot 1
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A Single 0.5 mL subcutaneous injection at Day 0
Other Name: ProQuad
Experimental: 2
ProQuad Lot 2
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A Single 0.5 mL subcutaneous injection at Day 0
Other Name: ProQuad
Experimental: 3
ProQuad Lot 3
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A Single 0.5 mL subcutaneous injection at Day 0
Other Name: ProQuad
Active Comparator: 4
M-M-R II + Varivax
Biological: Comparator: Varivax
A Single 0.5 mL subcutaneous injection at Day 0
Biological: Comparator: M-M-R II
A Single 0.5 mL subcutaneous injection at Day 0


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline

  2. Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline

  3. Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 Ab units/mL) to Mumps at Baseline

  4. Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline

  5. Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination ]
    Postvaccination observed Geometric Mean Titer of antibody to Varicella

  6. Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination ]
    Postvaccination observed Geometric Mean Titer of antibody to Measles.

  7. Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination ]
    Postvaccination observed Geometric Mean Titer of antibody to Mumps.

  8. Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination ]
    Postvaccination observed Geometric Mean Titer of antibody to Rubella

  9. Number of Participants With Serious Vaccine-related CAEs [ Time Frame: 6 weeks Postvaccination ]
    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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985153


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: NCT00985153     History of Changes
Other Study ID Numbers: V221-012
2009_669
First Posted: September 28, 2009    Key Record Dates
Results First Posted: February 9, 2010
Last Update Posted: November 23, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Measles
Chickenpox
Herpes Zoster
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs