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Trial record 4 of 6 for:    vaccine | Completed Studies | varicella | Child | Phase 4 | Industry

Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00326183
Recruitment Status : Completed
First Posted : May 16, 2006
Results First Posted : November 20, 2008
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Hepatitis A
Measles
Mumps
Rubella
Chickenpox
Interventions Biological: VAQTA®
Biological: ProQuad
Enrollment 1800
Recruitment Details

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  
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description Hepatitis A vaccine, inactivated Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Period Title: Overall Study
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
Reason Not Completed
Lost to Follow-up             104             56
Protocol Violation             6             3
Withdrawal by Subject             35             7
Subject Moved             7             4
Other             47             13
Adverse Event             1             0
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™ Total
Hide Arm/Group Description Hepatitis A vaccine, inactivated Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live Total of all reporting groups
Overall Number of Baseline Participants 1453 347 1800
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 1453 participants 347 participants 1800 participants
13.3  (1.49) 12.5  (0.90) 13.2  (1.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1453 participants 347 participants 1800 participants
Female
703
  48.4%
176
  50.7%
879
  48.8%
Male
750
  51.6%
171
  49.3%
921
  51.2%
1.Primary Outcome
Title Participants With 1 or More Serious Vaccine-Related Adverse Experiences
Hide Description [Not Specified]
Time Frame Days 1 to 14 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 1415 334
Measure Type: Number
Unit of Measure: participants
0 1
2.Primary Outcome
Title Participants With 1 or More Injection-Site Adverse Experiences
Hide Description [Not Specified]
Time Frame Days 1 to 14 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 1415 334
Measure Type: Number
Unit of Measure: participants
701 164
3.Primary Outcome
Title Participants With Measles-Like Rash After First Vaccination
Hide Description [Not Specified]
Time Frame Days 1 to 28 After First Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 0 328
Measure Type: Number
Unit of Measure: participants
13
4.Primary Outcome
Title Participants With Measles-Like Rash After Second Vaccination
Hide Description [Not Specified]
Time Frame Days 1 to 28 After Second Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 0 263
Measure Type: Number
Unit of Measure: participants
5
5.Primary Outcome
Title Participants With Mumps-Like Symptoms After First Vaccination
Hide Description [Not Specified]
Time Frame Days 1 to 28 After First Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 0 328
Measure Type: Number
Unit of Measure: participants
0
6.Primary Outcome
Title Participants With Mumps-Like Symptoms After Second Vaccination
Hide Description [Not Specified]
Time Frame Days 1 to 28 After Second Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 0 263
Measure Type: Number
Unit of Measure: participants
0
7.Primary Outcome
Title Participants With Rubella-Like Rash After First Vaccination
Hide Description [Not Specified]
Time Frame Days 1 to 28 After First Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 0 328
Measure Type: Number
Unit of Measure: participants
1
8.Primary Outcome
Title Participants With Rubella-Like Rash After Second Vaccination
Hide Description [Not Specified]
Time Frame Days 1 to 28 After Second Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 0 263
Measure Type: Number
Unit of Measure: participants
0
9.Primary Outcome
Title Participants With Varicella/Zoster-Like Rash After First Vaccination
Hide Description [Not Specified]
Time Frame Days 1 to 28 After First Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 0 328
Measure Type: Number
Unit of Measure: participants
0
10.Primary Outcome
Title Participants With Varicella/Zoster-Like Rash After Second Vaccination
Hide Description [Not Specified]
Time Frame Days 1 to 28 After Second Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 0 263
Measure Type: Number
Unit of Measure: participants
0
11.Primary Outcome
Title Participants With Elevated Temperature (>=102.2F/39.0C)
Hide Description [Not Specified]
Time Frame Days 1 to 5 After Any Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided body temperature follow-up data after any dose of vaccine.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 1383 320
Measure Type: Number
Unit of Measure: participants
56 13
12.Secondary Outcome
Title Participants With 1 or More Systemic Adverse Experiences
Hide Description [Not Specified]
Time Frame Days 1 to 14 After Any Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.
Arm/Group Title Arm 1: VAQTA™ Arm 2: VAQTA™ +ProQuad™
Hide Arm/Group Description:
Hepatitis A vaccine, inactivated
Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Number of Participants Analyzed 1415 334
Measure Type: Number
Unit of Measure: participants
782 197
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00326183     History of Changes
Other Study ID Numbers: V251-066
2006_023
First Submitted: May 12, 2006
First Posted: May 16, 2006
Results First Submitted: October 21, 2008
Results First Posted: November 20, 2008
Last Update Posted: February 4, 2019