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Trial record 50 of 141 for:    "Measles"

Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

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: NCT01536405
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : July 2, 2014
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Measles
Mumps
Rubella
Varicella
Interventions Biological: MMRV (AMP)
Biological: MMRV (2006 process)
Enrollment 1412
Recruitment Details  
Pre-assignment Details One participant was inadvertently randomized twice, for a total of 1413 randomizations. The Participant Flow reported below includes this participant only once.
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP) Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Period Title: Randomization to Visit 1 (Vaccination 1)
Started 706 706
Completed 698 702
Not Completed 8 4
Reason Not Completed
Not vaccinated             8             4
Period Title: Visit 1 (Vaccination 1) to Visit 2
Started 698 702
Received Vaccination 1 698 702
Completed 666 662
Not Completed 32 40
Reason Not Completed
Withdrawal by Subject             12             18
Lost to Follow-up             20             22
Period Title: Visit 2 to Visit 3 (Vaccination 2)
Started 666 662
Completed 635 634
Not Completed 31 28
Reason Not Completed
Withdrawal by Subject             17             13
Adverse Event             3             3
Lost to Follow-up             9             10
Protocol Violation             2             2
Period Title: Visit 3 (Vaccination 2) to Visit 4
Started 635 634
Received Vaccination 2 634 632
Completed 615 618
Not Completed 20 16
Reason Not Completed
Withdrawal by Subject             3             2
Adverse Event             1             0
Lost to Follow-up             16             14
Period Title: Visit 4 to Extended Study Follow-up
Started 615 618
Completed 595 595
Not Completed 20 23
Reason Not Completed
Withdrawal by Subject             0             2
Adverse Event             0             1
Lost to Follow-up             20             20
Arm/Group Title MMRV (AMP) MMRV (2006 Process) Total
Hide Arm/Group Description Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP) Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process Total of all reporting groups
Overall Number of Baseline Participants 706 706 1412
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 706 participants 706 participants 1412 participants
13.4  (2.2) 13.6  (2.5) 13.5  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 706 participants 706 participants 1412 participants
Female
344
  48.7%
324
  45.9%
668
  47.3%
Male
362
  51.3%
382
  54.1%
744
  52.7%
1.Primary Outcome
Title Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
Hide Description Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Time Frame Six weeks after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 586 589
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.3
(95.6 to 98.4)
93.0
(90.7 to 95.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease >= the prespecified criterion of 10 percentage points
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
1.8 to 6.8
Estimation Comments RD = MMRV (AMP) - MMRV (2006 process)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMRV (AMP)
Comments Acceptability of the antibody response rate was based on a lower bound of the 95% CI being >76%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sample binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Response rate
Estimated Value 97.3
Confidence Interval (2-Sided) 95%
95.6 to 98.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
Hide Description Sera were tested for measles virus IgG antibody levels by an ELISA
Time Frame Six weeks after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 629 621
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
96.7
(94.9 to 97.9)
98.9
(97.7 to 99.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-4.0 to -0.6
Estimation Comments RD = MMRV (AMP) - MMRV (2006 process)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMRV (AMP)
Comments Acceptability of the antibody response rate was based on a lower bound of the 95% CI being >90%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sample binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Response rate
Estimated Value 96.7
Confidence Interval (2-Sided) 95%
94.9 to 97.9
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
Hide Description Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
Time Frame Six weeks after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 618 610
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
98.2
(96.8 to 99.1)
97.2
(95.6 to 98.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-0.7 to 2.8
Estimation Comments RD = MMRV (AMP) - MMRV (2006 process)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMRV (AMP)
Comments Acceptability of the antibody response rate was based on a lower bound of the 95% CI being >90%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sample binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Response rate
Estimated Value 98.2
Confidence Interval (2-Sided) 95%
96.8 to 99.1
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
Hide Description Sera were tested for rubella virus IgG antibody levels by an ELISA
Time Frame Six weeks after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 608 593
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
98.8
(97.6 to 99.5)
99.3
(98.3 to 99.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.8 to 0.7
Estimation Comments RD = MMRV (AMP) - MMRV (2006 process)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMRV (AMP)
Comments Acceptability of the antibody response rate was based on a lower bound of the 95% CI being >90%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sample binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Response rate
Estimated Value 98.8
Confidence Interval (2-Sided) 95%
97.6 to 99.5
Estimation Comments [Not Specified]
5.Primary Outcome
Title Geometric Mean Titer (GMT) of VZV Antibodies
Hide Description Sera were tested for VZV IgG antibody levels by gpELISA
Time Frame Six weeks after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 586 589
Geometric Mean (95% Confidence Interval)
Unit of Measure: ELISA units/mL
17.3
(16.4 to 18.3)
14.4
(13.6 to 15.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments Analysis was based on log-transformed titers
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.1 to 1.3
Estimation Comments GMT ratio = MMRV (AMP) / MMRV (2006 process)
6.Primary Outcome
Title Geometric Mean Titer (GMT) of Measles Virus Antibodies
Hide Description Sera were tested for measles virus IgG antibody levels by ELISA
Time Frame Six weeks after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 629 621
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
3426.5
(3162.5 to 3712.4)
3719.5
(3506.0 to 3946.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments Analysis was based on log-transformed titers
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.8 to 1.0
Estimation Comments GMT ratio = MMRV (AMP) / MMRV (2006 process)
7.Primary Outcome
Title Geometric Mean Titer (GMT) of Mumps Virus Antibodies
Hide Description Sera were tested for mumps virus IgG antibody levels by ELISA
Time Frame Six weeks after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 618 610
Geometric Mean (95% Confidence Interval)
Unit of Measure: Mumps Ab units/mL
112.1
(104.1 to 120.7)
114.0
(105.8 to 122.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments Analysis was based on log-transformed titers
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.9 to 1.1
Estimation Comments GMT ratio = MMRV (AMP) / MMRV (2006 process)
8.Primary Outcome
Title Geometric Mean Titer (GMT) of Rubella Virus Antibodies
Hide Description Sera were tested for rubella virus IgG antibody levels by ELISA
Time Frame Six weeks after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 608 593
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
81.8
(76.8 to 87.2)
80.7
(76.4 to 85.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments Analysis was based on log-transformed titers
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.9 to 1.1
Estimation Comments GMT ratio = MMRV (AMP) / MMRV (2006 process)
9.Primary Outcome
Title Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Hide Description [Not Specified]
Time Frame Up to 5 days after vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants who received >=1 study vaccination and had follow-up safety data
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 645 648
Measure Type: Number
Unit of Measure: Percentage of participants
0.9 0.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMRV (AMP), MMRV (2006 Process)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-1.0 to 1.3
Estimation Comments RD = MMRV (AMP) - MMRV (2006 process)
10.Secondary Outcome
Title Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Hide Description [Not Specified]
Time Frame Up to 42 days after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants who received >=1 study vaccination and had follow-up safety data
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 650 649
Measure Type: Number
Unit of Measure: Percentage of participants
Vaccination 1; n=650, n=649 10.0 10.6
Vaccination 2; n=592, n=597 5.7 8.4
11.Secondary Outcome
Title Percentage of Participants With Zoster-like Rash
Hide Description [Not Specified]
Time Frame Up to 42 days after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants who received >=1 study vaccination and had follow-up safety data
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 682 682
Measure Type: Number
Unit of Measure: Percentage of participants
Vaccination 1; n=682, n=682 0.0 0.0
Vaccination 2; n=634, n=632 0.0 0.0
12.Secondary Outcome
Title Percentage of Participants With Mumps-like Symptoms
Hide Description [Not Specified]
Time Frame Up to 42 days after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants who received >=1 study vaccination and had follow-up safety data
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 682 682
Measure Type: Number
Unit of Measure: Percentage of participants
Vaccination 1; n=682, n=682 0.0 0.0
Vaccination 2; n=634, n=632 0.0 0.0
13.Secondary Outcome
Title Percentage of Participants With Measles-like Rash
Hide Description [Not Specified]
Time Frame Up to 42 days after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants who received >=1 study vaccination and had follow-up safety data
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 682 682
Measure Type: Number
Unit of Measure: Percentage of participants
Vaccination 1; n=682, n=682 0.1 0.3
Vaccination 2; n=634, n=632 0.2 0.0
14.Secondary Outcome
Title Percentage of Participants With Rubella-like Rash
Hide Description [Not Specified]
Time Frame Up to 42 days after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants who received >=1 study vaccination and had follow-up safety data
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 682 682
Measure Type: Number
Unit of Measure: Percentage of participants
Vaccination 1; n=682, n=682 0.0 0.0
Vaccination 2; n=634, n=632 0.0 0.0
15.Secondary Outcome
Title Percentage of Participants With Varicella-like Rash
Hide Description [Not Specified]
Time Frame Up to 42 days after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants who received >=1 study vaccination and had follow-up safety data
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 682 682
Measure Type: Number
Unit of Measure: Percentage of participants
Vaccination 1; n=682, n=682 0.6 0.0
Vaccination 2; n=634, n=632 0.0 0.0
16.Secondary Outcome
Title Percentage of Participants With an Injection-site Adverse Event
Hide Description An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.
Time Frame Up to 5 days after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants who received >=1 study vaccination and had follow-up safety data
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description:
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Overall Number of Participants Analyzed 682 682
Measure Type: Number
Unit of Measure: Percentage of participants
Vaccination 1; n=682, n=682 36.4 29.8
Vaccination 2; n=634, n=632 35.5 29.6
Time Frame Up to 6 months (180 days) after vaccination 2
Adverse Event Reporting Description The All Subjects as Treated population included randomized participants who received >=1 dose of study vaccine and had safety follow-up results
 
Arm/Group Title MMRV (AMP) MMRV (2006 Process)
Hide Arm/Group Description Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP) Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
All-Cause Mortality
MMRV (AMP) MMRV (2006 Process)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MMRV (AMP) MMRV (2006 Process)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/682 (3.08%)      18/683 (2.64%)    
General disorders     
Pyrexia  0/682 (0.00%)  0 1/683 (0.15%)  1
Infections and infestations     
Abscess limb  0/682 (0.00%)  0 1/683 (0.15%)  1
Bronchiolitis  1/682 (0.15%)  1 2/683 (0.29%)  2
Cellulitis staphylcoccal  0/682 (0.00%)  0 1/683 (0.15%)  1
Croup infectious  1/682 (0.15%)  1 2/683 (0.29%)  2
Gastroenteritis  2/682 (0.29%)  2 0/683 (0.00%)  0
Groin abscess  0/682 (0.00%)  0 1/683 (0.15%)  1
Lobar pneumonia  0/682 (0.00%)  0 1/683 (0.15%)  1
Lower respiratory tract infection  0/682 (0.00%)  0 1/683 (0.15%)  1
Otitis media  1/682 (0.15%)  1 0/683 (0.00%)  0
Periorbital cellulitis  0/682 (0.00%)  0 1/683 (0.15%)  1
Pharyngitis streptococcal  0/682 (0.00%)  0 1/683 (0.15%)  1
Pneumonia  1/682 (0.15%)  1 0/683 (0.00%)  0
Pneumonia viral  0/682 (0.00%)  0 2/683 (0.29%)  2
Respiratory syncytial virus bronchiolitis  1/682 (0.15%)  1 0/683 (0.00%)  0
Respiratory syncytial virus infection  0/682 (0.00%)  0 1/683 (0.15%)  1
Staphylococcal abscess  1/682 (0.15%)  1 0/683 (0.00%)  0
Subcutaneous abscess  1/682 (0.15%)  1 1/683 (0.15%)  1
Viral upper respiratory tract infection  1/682 (0.15%)  1 0/683 (0.00%)  0
Vulval abscess  1/682 (0.15%)  1 0/683 (0.00%)  0
Injury, poisoning and procedural complications     
Exposure via direct contact  1/682 (0.15%)  1 0/683 (0.00%)  0
Exposure via ingestion  1/682 (0.15%)  1 0/683 (0.00%)  0
Foreign body aspiration  1/682 (0.15%)  1 0/683 (0.00%)  0
Skull fracture  1/682 (0.15%)  1 0/683 (0.00%)  0
Upper limb fracture  1/682 (0.15%)  1 0/683 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  2/682 (0.29%)  2 0/683 (0.00%)  0
Metabolic acidosis  1/682 (0.15%)  1 0/683 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Juvenile idiopathic arthritis  0/682 (0.00%)  0 1/683 (0.15%)  1
Nervous system disorders     
Febrile convulsion  4/682 (0.59%)  5 1/683 (0.15%)  1
Status epilepticus  1/682 (0.15%)  1 0/683 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1/682 (0.15%)  1 3/683 (0.44%)  3
Bronchial hyperreactivity  0/682 (0.00%)  0 1/683 (0.15%)  1
Dyspnoea  0/682 (0.00%)  0 1/683 (0.15%)  1
Hypoxia  0/682 (0.00%)  0 1/683 (0.15%)  1
Status asthmaticus  0/682 (0.00%)  0 1/683 (0.15%)  2
Vascular disorders     
Kawasaki's disease  1/682 (0.15%)  1 0/683 (0.00%)  0
1
Term from vocabulary, MedDRA 16
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MMRV (AMP) MMRV (2006 Process)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   574/682 (84.16%)      572/683 (83.75%)    
Eye disorders     
Conjunctivitis  48/682 (7.04%)  52 46/683 (6.73%)  47
Gastrointestinal disorders     
Diarrhoea  77/682 (11.29%)  98 91/683 (13.32%)  107
Vomiting  60/682 (8.80%)  77 61/683 (8.93%)  72
General disorders     
Injection site erythema  254/682 (37.24%)  344 199/683 (29.14%)  258
Injection site pain  208/682 (30.50%)  267 187/683 (27.38%)  243
Injection site swelling  156/682 (22.87%)  190 123/683 (18.01%)  146
Pyrexia  225/682 (32.99%)  349 235/683 (34.41%)  360
Infections and infestations     
Gastroenteritis  29/682 (4.25%)  32 41/683 (6.00%)  43
Nasopharyngitis  55/682 (8.06%)  65 66/683 (9.66%)  76
Otitis media  128/682 (18.77%)  177 128/683 (18.74%)  179
Otitis media acute  56/682 (8.21%)  72 44/683 (6.44%)  57
Pharyngitis  40/682 (5.87%)  47 35/683 (5.12%)  43
Upper respiratory tract infection  159/682 (23.31%)  210 163/683 (23.87%)  212
Viral infection  44/682 (6.45%)  52 57/683 (8.35%)  64
Respiratory, thoracic and mediastinal disorders     
Cough  87/682 (12.76%)  113 101/683 (14.79%)  118
Rhinorrhoea  58/682 (8.50%)  78 53/683 (7.76%)  64
Skin and subcutaneous tissue disorders     
Dermatitis diaper  62/682 (9.09%)  76 77/683 (11.27%)  106
Rash  48/682 (7.04%)  50 47/683 (6.88%)  55
1
Term from vocabulary, MedDRA 16
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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01536405     History of Changes
Other Study ID Numbers: V221-027
P20930
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: May 30, 2014
Results First Posted: July 2, 2014
Last Update Posted: October 31, 2018