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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00326183
First received: May 12, 2006
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Hepatitis A Measles Mumps Rubella Chickenpox Biological: VAQTA® Biological: ProQuad Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Participants With 1 or More Systemic Adverse Experiences [ Time Frame: Days 1 to 14 After Any Vaccination ]

Enrollment: 1800
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arm 1: vaccine
Biological: VAQTA®
0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
Other Name: V251
Active Comparator: 2
Arm 2: Active comparator
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.

  Eligibility

Ages Eligible for Study:   12 Months to 17 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326183

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00326183     History of Changes
Other Study ID Numbers: V251-066
2006_023
Study First Received: May 12, 2006
Results First Received: October 21, 2008
Last Updated: January 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Hepatitis
Measles
Hepatitis A
Rubella
Chickenpox
Liver Diseases
Digestive System Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Rubivirus Infections
Togaviridae Infections
Herpesviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 20, 2017