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

This study has been completed.

Study NCT00326183. Last updated on November 18, 2008.

Information provided by Merck

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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
18 investigators in the United States; Date first subject visit: 26 Mar 2007 Date of last subject visit: 14-Nov-07

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
n/a

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

Participant Flow: Overall Study

	Arm 1: VAQTA™	Arm 2: VAQTA™ +ProQuad™
STARTED	1453	347
Vaccination 1 + Safety Follow-up	1453	347
Postvaccination 1 Post-Safety Follow-up	1393	325
Vaccination 2 + Safety Follow-up	1301	292
Postvaccination 2 Post-Safety Follow-up	1265	271
COMPLETED	1253	264
NOT COMPLETED	200	83
Lost to Follow-up	104	56
Protocol Violation	6	3
Withdrawal by Subject	35	7
Subject Moved	7	4
Unspecified	47	13
Adverse Event	1	0

Baseline Characteristics

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 Outcome Measure: Participants With 1 or More Serious Vaccine-Related Adverse Experiences

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2. Primary Outcome Measure: Participants With 1 or More Injection-Site Adverse Experiences

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3. Primary Outcome Measure: Participants With Measles-Like Rash After First Vaccination

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4. Primary Outcome Measure: Participants With Measles-Like Rash After Second Vaccination

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5. Primary Outcome Measure: Participants With Mumps-Like Symptoms After First Vaccination

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6. Primary Outcome Measure: Participants With Mumps-Like Symptoms After Second Vaccination

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7. Primary Outcome Measure: Participants With Rubella-Like Rash After First Vaccination

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8. Primary Outcome Measure: Participants With Rubella-Like Rash After Second Vaccination

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9. Primary Outcome Measure: Participants With Varicella/Zoster-Like Rash After First Vaccination

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10. Primary Outcome Measure: Participants With Varicella/Zoster-Like Rash After Second Vaccination

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11. Primary Outcome Measure: Participants With Elevated Temperature (>=102.2F / 39.0C)

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12. Secondary Outcome Measure: Participants With 1 or More Systemic Adverse Experiences

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Reported Adverse Events

Adverse event information has not been entered for this trial.

The submission of adverse events information is currently optional and is not mandated under U.S. Federal Law (US Public Law 110-85, Title VIII) until September 27, 2009.

More Information

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

Responsible Party:	Merck & Co., Inc. ( Dr. Barry Gertz, 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:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00326183
Health Authority:	United States: Food and Drug Administration