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

Hide 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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

3. Primary:

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

Show Outcome Measure 3

4. Primary:

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

Show Outcome Measure 4

5. Primary:

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

Show Outcome Measure 5

6. Primary:

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

Show Outcome Measure 6

7. Primary:

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

Show Outcome Measure 7

8. Primary:

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

Show Outcome Measure 8

9. Primary:

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

Show Outcome Measure 9

10. Primary:

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

Show Outcome Measure 10

11. Primary:

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

Show Outcome Measure 11

12. Secondary:

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

Hide Outcome Measure 12

Measure Type	Secondary
Measure Title	Participants With 1 or More Systemic Adverse Experiences
Measure Description	No text entered.
Time Frame	Days 1 to 14 After Any 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 any dose of vaccine out of the total number of subjects enrolled.

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]	1415	334
Participants With 1 or More Systemic Adverse Experiences [units: participants]	782	197

No statistical analysis provided for Participants With 1 or More Systemic Adverse Experiences

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide 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
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