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Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00985153
First received: September 25, 2009
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL [ 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 Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 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 < 120 mIU/mL) to Measles at Baseline

  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 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 < 10 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 Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to Varicella

  • 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to Measles.

  • 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to Mumps.

  • 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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to Rubella

  • Number of Participants With Serious Vaccine-related CAEs [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    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).


Enrollment: 3927
Study Start Date: March 2000
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985153

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00985153     History of Changes
Other Study ID Numbers: 2009_669, V221-012
Study First Received: September 25, 2009
Results First Received: January 13, 2010
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013