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

An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age

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.

Study Overview

• Status: Completed
• Conditions: Measles; Hepatitis A; Rubella; Mumps; Chickenpox
• Intervention / Treatment: Biological: VAQTA®; Biological: ProQuad

• Study Type: Interventional
• Enrollment (Actual): 1800
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: V251; Biological: ProQuad; 0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participants With 1 or More Serious Vaccine-Related Adverse Experiences	Days 1 to 14 after any vaccination
Participants With 1 or More Injection-Site Adverse Experiences	Days 1 to 14 after any vaccination
Participants With Measles-Like Rash After First Vaccination	Days 1 to 28 After First Vaccination
Participants With Measles-Like Rash After Second Vaccination	Days 1 to 28 After Second Vaccination
Participants With Mumps-Like Symptoms After First Vaccination	Days 1 to 28 After First Vaccination
Participants With Mumps-Like Symptoms After Second Vaccination	Days 1 to 28 After Second Vaccination
Participants With Rubella-Like Rash After First Vaccination	Days 1 to 28 After First Vaccination
Participants With Rubella-Like Rash After Second Vaccination	Days 1 to 28 After Second Vaccination
Participants With Varicella/Zoster-Like Rash After First Vaccination	Days 1 to 28 After First Vaccination
Participants With Varicella/Zoster-Like Rash After Second Vaccination	Days 1 to 28 After Second Vaccination
Participants With Elevated Temperature (>=102.2F/39.0C)	Days 1 to 5 After Any Vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Participants With 1 or More Systemic Adverse Experiences	Days 1 to 14 After Any Vaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2007
• Primary Completion (ACTUAL): January 15, 2008
• Study Completion (ACTUAL): January 15, 2008

Study Registration Dates

• First Submitted: May 12, 2006
• First Submitted That Met QC Criteria: May 15, 2006
• First Posted (ESTIMATE): May 16, 2006

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; DNA Virus Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Enterovirus Infections; Picornaviridae Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Togaviridae Infections; Rubivirus Infections; Measles; Hepatitis; Hepatitis A; Chickenpox; Rubella
• Other Study ID Numbers: V251-066; 2006_023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf