Back to resultsHepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
Primary Purpose
Hepatitis A, Measles, Mumps
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
VAQTA®
ProQuad
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis A
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Arm 1: vaccine
Arm 2: Active comparator
Outcomes
Primary Outcome Measures
Participants With 1 or More Serious Vaccine-Related Adverse Experiences
Participants With 1 or More Injection-Site Adverse Experiences
Participants With Measles-Like Rash After First Vaccination
Participants With Measles-Like Rash After Second Vaccination
Participants With Mumps-Like Symptoms After First Vaccination
Participants With Mumps-Like Symptoms After Second Vaccination
Participants With Rubella-Like Rash After First Vaccination
Participants With Rubella-Like Rash After Second Vaccination
Participants With Varicella/Zoster-Like Rash After First Vaccination
Participants With Varicella/Zoster-Like Rash After Second Vaccination
Participants With Elevated Temperature (>=102.2F/39.0C)
Secondary Outcome Measures
Participants With 1 or More Systemic Adverse Experiences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00326183
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 26, 2007 (Actual)
Primary Completion Date
January 15, 2008 (Actual)
Study Completion Date
January 15, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A, Measles, Mumps, Rubella, Chickenpox
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Arm 1: vaccine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm 2: Active comparator
Intervention Type
Biological
Intervention Name(s)
VAQTA®
Other Intervention Name(s)
V251
Intervention Description
0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
Intervention Type
Biological
Intervention Name(s)
ProQuad
Intervention Description
0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
Primary Outcome Measure Information:
Title
Participants With 1 or More Serious Vaccine-Related Adverse Experiences
Time Frame
Days 1 to 14 after any vaccination
Title
Participants With 1 or More Injection-Site Adverse Experiences
Time Frame
Days 1 to 14 after any vaccination
Title
Participants With Measles-Like Rash After First Vaccination
Time Frame
Days 1 to 28 After First Vaccination
Title
Participants With Measles-Like Rash After Second Vaccination
Time Frame
Days 1 to 28 After Second Vaccination
Title
Participants With Mumps-Like Symptoms After First Vaccination
Time Frame
Days 1 to 28 After First Vaccination
Title
Participants With Mumps-Like Symptoms After Second Vaccination
Time Frame
Days 1 to 28 After Second Vaccination
Title
Participants With Rubella-Like Rash After First Vaccination
Time Frame
Days 1 to 28 After First Vaccination
Title
Participants With Rubella-Like Rash After Second Vaccination
Time Frame
Days 1 to 28 After Second Vaccination
Title
Participants With Varicella/Zoster-Like Rash After First Vaccination
Time Frame
Days 1 to 28 After First Vaccination
Title
Participants With Varicella/Zoster-Like Rash After Second Vaccination
Time Frame
Days 1 to 28 After Second Vaccination
Title
Participants With Elevated Temperature (>=102.2F/39.0C)
Time Frame
Days 1 to 5 After Any Vaccination
Secondary Outcome Measure Information:
Title
Participants With 1 or More Systemic Adverse Experiences
Time Frame
Days 1 to 14 After Any Vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
17 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
30431383
Citation
Petrecz M, Acosta CJ, Klopfer SO, Kuter BJ, Goveia MG, Stek JE, Schodel FP, Lee AW. Safety and immunogenicity of VAQTA(R) 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.
Results Reference
background
Learn more about this trial
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
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