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

Purpose

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	Intervention	Phase
Hepatitis A Measles Mumps Rubella Chickenpox	Biological: VAQTA® Biological: ProQuad	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Hepatitis Hepatitis A Measles Mumps Rashes Rubella Shingles

Drug Information available for: Hepatitis A Vaccines

Genetic and Rare Diseases Information Center resources: Measles Mumps Rubella

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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


Enrollment:	1800
Study Start Date:	May 2006
Study Completion Date:	January 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 VAQTA®
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 VAQTA® Biological: ProQuad 0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment. Other Name: ProQuad

Eligibility


Ages Eligible for Study:	12 Months to 17 Months
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326183

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

No publications provided


Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00326183 History of Changes
Other Study ID Numbers:	2006_023, V251-066
Study First Received:	May 12, 2006
Results First Received:	October 21, 2008
Last Updated:	February 19, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Hepatitis A Digestive System Diseases Enterovirus Infections Hepatitis Hepatitis, Viral, Human	Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases

ClinicalTrials.gov processed this record on March 03, 2015