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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hepatitis A; Measles; Mumps; Rubella; Chickenpox	Biological: VAQTA®; Biological: ProQuad	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1800 participants
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
Study Start Date :	March 2007
Actual Primary Completion Date :	January 2008
Actual Study Completion Date :	January 2008

Arms and Interventions

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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 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.

Outcome Measures

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Primary Outcome Measures :

1. Participants With 1 or More Serious Vaccine-Related Adverse Experiences [ Time Frame: Days 1 to 14 after any vaccination ]
2. Participants With 1 or More Injection-Site Adverse Experiences [ Time Frame: Days 1 to 14 after any vaccination ]
3. Participants With Measles-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
4. Participants With Measles-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
5. Participants With Mumps-Like Symptoms After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
6. Participants With Mumps-Like Symptoms After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
7. Participants With Rubella-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
8. Participants With Rubella-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
9. Participants With Varicella/Zoster-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
10. Participants With Varicella/Zoster-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
11. Participants With Elevated Temperature (>=102.2F/39.0C) [ Time Frame: Days 1 to 5 After Any Vaccination ]

Secondary Outcome Measures :

1. Participants With 1 or More Systemic Adverse Experiences [ Time Frame: Days 1 to 14 After Any Vaccination ]

Eligibility Criteria

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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

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Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00326183 History of Changes
Other Study ID Numbers:	V251-066; 2006_023
First Posted:	May 16, 2006
Results First Posted:	November 20, 2008
Last Update Posted:	March 13, 2017
Last Verified:	January 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