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

This study has been completed.

Study NCT00326183 Information provided by Merck

First Received: May 12, 2006 Last Updated: February 19, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Parallel Assignment
Conditions:	Hepatitis A Measles Mumps Rubella Chickenpox
Interventions:	Biological: VAQTA® Biological: ProQuad

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Arm 1: VAQTA™	Hepatitis A vaccine, inactivated
Arm 2: VAQTA™ +ProQuad™	Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live

Baseline Measures

	Arm 1: VAQTA™	Arm 2: VAQTA™ +ProQuad™	Total
Number of Participants [units: participants]	1453	347	1800
Age [units: months] Mean ± Standard Deviation	13.3 ± 1.49	12.5 ± 0.90	13.2 ± 1.43
Gender [units: participants]
Female	703	176	879
Male	750	171	921

Outcome Measures

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1. Primary:

Participants With 1 or More Serious Vaccine-Related Adverse Experiences [ Days 1 to 14 after any vaccination ]

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2. Primary:

Participants With 1 or More Injection-Site Adverse Experiences [ Days 1 to 14 after any vaccination ]

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3. Primary:

Participants With Measles-Like Rash After First Vaccination [ Days 1 to 28 After First Vaccination ]

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4. Primary:

Participants With Measles-Like Rash After Second Vaccination [ Days 1 to 28 After Second Vaccination ]

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5. Primary:

Participants With Mumps-Like Symptoms After First Vaccination [ Days 1 to 28 After First Vaccination ]

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6. Primary:

Participants With Mumps-Like Symptoms After Second Vaccination [ Days 1 to 28 After Second Vaccination ]

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7. Primary:

Participants With Rubella-Like Rash After First Vaccination [ Days 1 to 28 After First Vaccination ]

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8. Primary:

Participants With Rubella-Like Rash After Second Vaccination [ Days 1 to 28 After Second Vaccination ]

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9. Primary:

Participants With Varicella/Zoster-Like Rash After First Vaccination [ Days 1 to 28 After First Vaccination ]

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10. Primary:

Participants With Varicella/Zoster-Like Rash After Second Vaccination [ Days 1 to 28 After Second Vaccination ]

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11. Primary:

Participants With Elevated Temperature (>=102.2F/39.0C) [ Days 1 to 5 After Any Vaccination ]

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12. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372

No publications provided

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