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

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: May 12, 2006
• First Posted Date: May 16, 2006
• Results First Submitted Date: October 21, 2008
• Results First Posted Date: November 20, 2008
• Last Update Posted Date: February 4, 2019
• Actual Study Start Date: March 26, 2007
• Actual Primary Completion Date: January 15, 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 18, 2008)

• 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 (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.
• Current Secondary Outcome Measures (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 (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: Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Hepatitis A
• Measles
• Mumps
• Rubella
• Chickenpox

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 15, 2006): 1800
• Original Enrollment: Same as current
• Actual Study Completion Date: January 15, 2008
• Actual Primary Completion Date: January 15, 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 12 Months to 17 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00326183
• Other Study ID Numbers: V251-066; 2006_023
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: January 2019