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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00326183
First received: May 12, 2006
Last updated: February 19, 2009
Last verified: January 2009
History of Changes
Results First Received: October 21, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Hepatitis A
Measles
Mumps
Rubella
Chickenpox
Interventions: Biological: VAQTA®
Biological: ProQuad

  Participant Flow
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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.

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
Total Total of all reporting groups

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   [ Time Frame: Days 1 to 14 after any vaccination ]
  Show Outcome Measure 1

2.  Primary:   Participants With 1 or More Injection-Site Adverse Experiences   [ Time Frame: Days 1 to 14 after any vaccination ]
  Show Outcome Measure 2

3.  Primary:   Participants With Measles-Like Rash After First Vaccination   [ Time Frame: Days 1 to 28 After First Vaccination ]
  Show Outcome Measure 3

4.  Primary:   Participants With Measles-Like Rash After Second Vaccination   [ Time Frame: Days 1 to 28 After Second Vaccination ]
  Show Outcome Measure 4

5.  Primary:   Participants With Mumps-Like Symptoms After First Vaccination   [ Time Frame: Days 1 to 28 After First Vaccination ]
  Show Outcome Measure 5

6.  Primary:   Participants With Mumps-Like Symptoms After Second Vaccination   [ Time Frame: Days 1 to 28 After Second Vaccination ]
  Show Outcome Measure 6

7.  Primary:   Participants With Rubella-Like Rash After First Vaccination   [ Time Frame: Days 1 to 28 After First Vaccination ]
  Show Outcome Measure 7

8.  Primary:   Participants With Rubella-Like Rash After Second Vaccination   [ Time Frame: Days 1 to 28 After Second Vaccination ]
  Show Outcome Measure 8

9.  Primary:   Participants With Varicella/Zoster-Like Rash After First Vaccination   [ Time Frame: Days 1 to 28 After First Vaccination ]
  Show Outcome Measure 9

10.  Primary:   Participants With Varicella/Zoster-Like Rash After Second Vaccination   [ Time Frame: Days 1 to 28 After Second Vaccination ]
  Show Outcome Measure 10

11.  Primary:   Participants With Elevated Temperature (>=102.2F/39.0C)   [ Time Frame: Days 1 to 5 After Any Vaccination ]
  Show Outcome Measure 11

12.  Secondary:   Participants With 1 or More Systemic Adverse Experiences   [ Time Frame: Days 1 to 14 After Any Vaccination ]
  Show Outcome Measure 12


  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: 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