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Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00326183
Recruitment Status : Completed
First Posted : May 16, 2006
Results First Posted : November 20, 2008
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 12, 2006
First Posted Date  ICMJE May 16, 2006
Results First Submitted Date  ICMJE October 21, 2008
Results First Posted Date  ICMJE November 20, 2008
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE March 26, 2007
Actual Primary Completion Date January 15, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
  • Participants With 1 or More Serious Vaccine-Related Adverse Experiences [ Time Frame: Days 1 to 14 after any vaccination ]
  • Participants With 1 or More Injection-Site Adverse Experiences [ Time Frame: Days 1 to 14 after any vaccination ]
  • Participants With Measles-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
  • Participants With Measles-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
  • Participants With Mumps-Like Symptoms After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
  • Participants With Mumps-Like Symptoms After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
  • Participants With Rubella-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
  • Participants With Rubella-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
  • Participants With Varicella/Zoster-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
  • Participants With Varicella/Zoster-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
  • Participants With Elevated Temperature (>=102.2F/39.0C) [ Time Frame: Days 1 to 5 After Any Vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2006)
vaccine-related serious adverse experiences, injection-site adverse experiences (redness, swelling, pain, rash), measles-like rash, mumps-like symptoms, rubella-like rash, & varicella/zoster-like rash, distribution of maximum temperature postvaccination.
Change History Complete list of historical versions of study NCT00326183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
Participants With 1 or More Systemic Adverse Experiences [ Time Frame: Days 1 to 14 After Any Vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2006)
all other systemic adverse experiences & injection-site adverse experiences.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
Official Title  ICMJE An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age
Brief Summary Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hepatitis A
  • Measles
  • Mumps
  • Rubella
  • Chickenpox
Intervention  ICMJE
  • Biological: VAQTA®
    0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
    Other Name: V251
  • Biological: ProQuad
    0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
Study Arms  ICMJE
  • Active Comparator: 1
    Arm 1: vaccine
    Intervention: Biological: VAQTA®
  • Active Comparator: 2
    Arm 2: Active comparator
    Interventions:
    • Biological: VAQTA®
    • Biological: ProQuad
Publications * Petrecz M, Acosta CJ, Klopfer SO, Kuter BJ, Goveia MG, Stek JE, Schödel FP, Lee AW. Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines. Hum Vaccin Immunother. 2019;15(2):426-432. doi: 10.1080/21645515.2018.1530934. Epub 2018 Nov 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2006)
1800
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 15, 2008
Actual Primary Completion Date January 15, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Negative clinical history of hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster
  • No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM)

Exclusion Criteria:

  • Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination
  • History of allergy to any vaccine component
  • History of seizure disorder
  • Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy
  • Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections
  • Recent (<72 hours) febrile illness (>100.3 degrees F [>37.9 degrees C] oral equivalent) prior to study vaccination.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 17 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00326183
Other Study ID Numbers  ICMJE V251-066
2006_023
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date January 2019

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