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

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 of first subject visit: 26-Mar-2007. Date of last subject visit: 14-Nov-2007.

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 of first subject visit: 26-Mar-2007.

Date of last subject visit: 14-Nov-2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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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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Measure Type	Primary
Measure Title	Participants With Mumps-Like Symptoms After First Vaccination
Measure Description	No text entered.
Time Frame	Days 1 to 28 After First Vaccination
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.

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

Measured Values

	Arm 1: VAQTA™	Arm 2: VAQTA™ +ProQuad™
Number of Participants Analyzed [units: participants]	0	328
Participants With Mumps-Like Symptoms After First Vaccination [units: participants]	0	0

No statistical analysis provided for Participants With Mumps-Like Symptoms After First Vaccination

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
No text entered.

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