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

Tracking Information

First Received Date ^ICMJE

May 12, 2006

Last Updated Date

February 19, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 1 or More Injection-Site Adverse Experiences [ Time Frame: Days 1 to 14 after any 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 Measles-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 First Vaccination [ Time Frame: Days 1 to 28 After First 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 ]
Participants With Rubella-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 Second Vaccination [ Time Frame: Days 1 to 28 After Second 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 Varicella/Zoster-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second 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 ]

Original Primary Outcome Measures ^ICMJE

vaccine-related serious adverse experiences, injection-site adverse experiences (redness, swelling, pain, rash), measles-like rash, mumps-like symptoms, rubella-like rash, & varicella/zoster-like rash, distribution of maximum temperature postvaccination.

Change History

Complete list of historical versions of study NCT00326183 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

all other systemic adverse experiences & injection-site adverse experiences.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatitis A
Measles
Mumps
Rubella
Chickenpox

Intervention ^ICMJE

Biological: VAQTA®
Biological: ProQuad

Study Arms / Comparison Groups

Active Comparator: Arm 1: vaccine
Active Comparator: Arm 2: Active comparator

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1800

Completion Date

January 2008

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00326183

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2006_023, V251-066

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP