Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

Participants With 1 or More Systemic Adverse Experiences [ Time Frame: Days 1 to 14 After Any Vaccination ] [ Designated as safety issue: Yes ]

Condition ^†

Hepatitis A
Measles
Mumps
Rubella
Chickenpox

Intervention ^†

Biological: VAQTA®
Biological: ProQuad

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

1800

Start Date ^†

May 2006

Completion Date

January 2008

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.

Gender

Both

Ages

12 Months to 17 Months

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00326183

Organization ID

2006_023

Secondary IDs ^††

V251-066

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2008

First Received Date ^†

May 12, 2006

Last Updated Date

November 18, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.