Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027) (NCT NCT01536405)
NCT ID: NCT01536405
Last Updated: 2018-10-31
Results Overview
Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1412 participants
Primary outcome timeframe
Six weeks after vaccination 1
Results posted on
2018-10-31
Participant Flow
One participant was inadvertently randomized twice, for a total of 1413 randomizations. The Participant Flow reported below includes this participant only once.
Participant milestones
| Measure |
MMRV (AMP)
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Randomization to Visit 1 (Vaccination 1)
STARTED
|
706
|
706
|
|
Randomization to Visit 1 (Vaccination 1)
COMPLETED
|
698
|
702
|
|
Randomization to Visit 1 (Vaccination 1)
NOT COMPLETED
|
8
|
4
|
|
Visit 1 (Vaccination 1) to Visit 2
STARTED
|
698
|
702
|
|
Visit 1 (Vaccination 1) to Visit 2
Received Vaccination 1
|
698
|
702
|
|
Visit 1 (Vaccination 1) to Visit 2
COMPLETED
|
666
|
662
|
|
Visit 1 (Vaccination 1) to Visit 2
NOT COMPLETED
|
32
|
40
|
|
Visit 2 to Visit 3 (Vaccination 2)
STARTED
|
666
|
662
|
|
Visit 2 to Visit 3 (Vaccination 2)
COMPLETED
|
635
|
634
|
|
Visit 2 to Visit 3 (Vaccination 2)
NOT COMPLETED
|
31
|
28
|
|
Visit 3 (Vaccination 2) to Visit 4
STARTED
|
635
|
634
|
|
Visit 3 (Vaccination 2) to Visit 4
Received Vaccination 2
|
634
|
632
|
|
Visit 3 (Vaccination 2) to Visit 4
COMPLETED
|
615
|
618
|
|
Visit 3 (Vaccination 2) to Visit 4
NOT COMPLETED
|
20
|
16
|
|
Visit 4 to Extended Study Follow-up
STARTED
|
615
|
618
|
|
Visit 4 to Extended Study Follow-up
COMPLETED
|
595
|
595
|
|
Visit 4 to Extended Study Follow-up
NOT COMPLETED
|
20
|
23
|
Reasons for withdrawal
| Measure |
MMRV (AMP)
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Randomization to Visit 1 (Vaccination 1)
Not vaccinated
|
8
|
4
|
|
Visit 1 (Vaccination 1) to Visit 2
Withdrawal by Subject
|
12
|
18
|
|
Visit 1 (Vaccination 1) to Visit 2
Lost to Follow-up
|
20
|
22
|
|
Visit 2 to Visit 3 (Vaccination 2)
Withdrawal by Subject
|
17
|
13
|
|
Visit 2 to Visit 3 (Vaccination 2)
Adverse Event
|
3
|
3
|
|
Visit 2 to Visit 3 (Vaccination 2)
Lost to Follow-up
|
9
|
10
|
|
Visit 2 to Visit 3 (Vaccination 2)
Protocol Violation
|
2
|
2
|
|
Visit 3 (Vaccination 2) to Visit 4
Withdrawal by Subject
|
3
|
2
|
|
Visit 3 (Vaccination 2) to Visit 4
Adverse Event
|
1
|
0
|
|
Visit 3 (Vaccination 2) to Visit 4
Lost to Follow-up
|
16
|
14
|
|
Visit 4 to Extended Study Follow-up
Withdrawal by Subject
|
0
|
2
|
|
Visit 4 to Extended Study Follow-up
Adverse Event
|
0
|
1
|
|
Visit 4 to Extended Study Follow-up
Lost to Follow-up
|
20
|
20
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
Baseline characteristics by cohort
| Measure |
MMRV (AMP)
n=706 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=706 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
Total
n=1412 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.4 Months
STANDARD_DEVIATION 2.2 • n=5 Participants
|
13.6 Months
STANDARD_DEVIATION 2.5 • n=7 Participants
|
13.5 Months
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
344 Participants
n=5 Participants
|
324 Participants
n=7 Participants
|
668 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
362 Participants
n=5 Participants
|
382 Participants
n=7 Participants
|
744 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six weeks after vaccination 1Population: The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results
Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Outcome measures
| Measure |
MMRV (AMP)
n=586 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=589 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
|
97.3 Percentage of participants
Interval 95.6 to 98.4
|
93.0 Percentage of participants
Interval 90.7 to 95.0
|
PRIMARY outcome
Timeframe: Six weeks after vaccination 1Population: The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results
Sera were tested for measles virus IgG antibody levels by an ELISA
Outcome measures
| Measure |
MMRV (AMP)
n=629 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=621 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
|
96.7 Percentage of participants
Interval 94.9 to 97.9
|
98.9 Percentage of participants
Interval 97.7 to 99.5
|
PRIMARY outcome
Timeframe: Six weeks after vaccination 1Population: The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results
Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
MMRV (AMP)
n=618 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=610 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
|
98.2 Percentage of participants
Interval 96.8 to 99.1
|
97.2 Percentage of participants
Interval 95.6 to 98.4
|
PRIMARY outcome
Timeframe: Six weeks after vaccination 1Population: The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results
Sera were tested for rubella virus IgG antibody levels by an ELISA
Outcome measures
| Measure |
MMRV (AMP)
n=608 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=593 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
|
98.8 Percentage of participants
Interval 97.6 to 99.5
|
99.3 Percentage of participants
Interval 98.3 to 99.8
|
PRIMARY outcome
Timeframe: Six weeks after vaccination 1Population: The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results
Sera were tested for VZV IgG antibody levels by gpELISA
Outcome measures
| Measure |
MMRV (AMP)
n=586 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=589 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Geometric Mean Titer (GMT) of VZV Antibodies
|
17.3 ELISA units/mL
Interval 16.4 to 18.3
|
14.4 ELISA units/mL
Interval 13.6 to 15.2
|
PRIMARY outcome
Timeframe: Six weeks after vaccination 1Population: The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results
Sera were tested for measles virus IgG antibody levels by ELISA
Outcome measures
| Measure |
MMRV (AMP)
n=629 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=621 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Measles Virus Antibodies
|
3426.5 mIU/mL
Interval 3162.5 to 3712.4
|
3719.5 mIU/mL
Interval 3506.0 to 3946.0
|
PRIMARY outcome
Timeframe: Six weeks after vaccination 1Population: The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results
Sera were tested for mumps virus IgG antibody levels by ELISA
Outcome measures
| Measure |
MMRV (AMP)
n=618 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=610 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Mumps Virus Antibodies
|
112.1 Mumps Ab units/mL
Interval 104.1 to 120.7
|
114.0 Mumps Ab units/mL
Interval 105.8 to 122.8
|
PRIMARY outcome
Timeframe: Six weeks after vaccination 1Population: The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results
Sera were tested for rubella virus IgG antibody levels by ELISA
Outcome measures
| Measure |
MMRV (AMP)
n=608 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=593 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Rubella Virus Antibodies
|
81.8 IU/mL
Interval 76.8 to 87.2
|
80.7 IU/mL
Interval 76.4 to 85.2
|
PRIMARY outcome
Timeframe: Up to 5 days after vaccination 1Population: The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data
Outcome measures
| Measure |
MMRV (AMP)
n=645 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=648 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
|
0.9 Percentage of participants
|
0.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days after each vaccinationPopulation: The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data
Outcome measures
| Measure |
MMRV (AMP)
n=650 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=649 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Vaccination 1; n=650, n=649
|
10.0 Percentage of participants
|
10.6 Percentage of participants
|
|
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Vaccination 2; n=592, n=597
|
5.7 Percentage of participants
|
8.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days after each vaccinationPopulation: The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data
Outcome measures
| Measure |
MMRV (AMP)
n=682 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=682 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Zoster-like Rash
Vaccination 1; n=682, n=682
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Zoster-like Rash
Vaccination 2; n=634, n=632
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days after each vaccinationPopulation: The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data
Outcome measures
| Measure |
MMRV (AMP)
n=682 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=682 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Mumps-like Symptoms
Vaccination 1; n=682, n=682
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Mumps-like Symptoms
Vaccination 2; n=634, n=632
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days after each vaccinationPopulation: The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data
Outcome measures
| Measure |
MMRV (AMP)
n=682 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=682 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Measles-like Rash
Vaccination 1; n=682, n=682
|
0.1 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With Measles-like Rash
Vaccination 2; n=634, n=632
|
0.2 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days after each vaccinationPopulation: The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data
Outcome measures
| Measure |
MMRV (AMP)
n=682 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=682 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Rubella-like Rash
Vaccination 1; n=682, n=682
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Rubella-like Rash
Vaccination 2; n=634, n=632
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days after each vaccinationPopulation: The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data
Outcome measures
| Measure |
MMRV (AMP)
n=682 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=682 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With Varicella-like Rash
Vaccination 1; n=682, n=682
|
0.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Varicella-like Rash
Vaccination 2; n=634, n=632
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after each vaccinationPopulation: The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data
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.
Outcome measures
| Measure |
MMRV (AMP)
n=682 Participants
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=682 Participants
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Percentage of Participants With an Injection-site Adverse Event
Vaccination 1; n=682, n=682
|
36.4 Percentage of participants
|
29.8 Percentage of participants
|
|
Percentage of Participants With an Injection-site Adverse Event
Vaccination 2; n=634, n=632
|
35.5 Percentage of participants
|
29.6 Percentage of participants
|
Adverse Events
MMRV (AMP)
Serious events: 21 serious events
Other events: 574 other events
Deaths: 0 deaths
MMRV (2006 Process)
Serious events: 18 serious events
Other events: 572 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MMRV (AMP)
n=682 participants at risk
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=683 participants at risk
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Abscess limb
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Bronchiolitis
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.29%
2/683 • Number of events 2 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Cellulitis staphylcoccal
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Croup infectious
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.29%
2/683 • Number of events 2 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Gastroenteritis
|
0.29%
2/682 • Number of events 2 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Groin abscess
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Otitis media
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Pneumonia
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.29%
2/683 • Number of events 2 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Staphylococcal abscess
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Subcutaneous abscess
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Vulval abscess
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Injury, poisoning and procedural complications
Exposure via direct contact
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Injury, poisoning and procedural complications
Exposure via ingestion
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
2/682 • Number of events 2 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Nervous system disorders
Febrile convulsion
|
0.59%
4/682 • Number of events 5 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Nervous system disorders
Status epilepticus
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.44%
3/683 • Number of events 3 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/682 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.15%
1/683 • Number of events 2 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Vascular disorders
Kawasaki's disease
|
0.15%
1/682 • Number of events 1 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
0.00%
0/683 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
Other adverse events
| Measure |
MMRV (AMP)
n=682 participants at risk
Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
|
MMRV (2006 Process)
n=683 participants at risk
Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
7.0%
48/682 • Number of events 52 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
6.7%
46/683 • Number of events 47 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
77/682 • Number of events 98 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
13.3%
91/683 • Number of events 107 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
60/682 • Number of events 77 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
8.9%
61/683 • Number of events 72 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
General disorders
Injection site erythema
|
37.2%
254/682 • Number of events 344 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
29.1%
199/683 • Number of events 258 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
General disorders
Injection site pain
|
30.5%
208/682 • Number of events 267 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
27.4%
187/683 • Number of events 243 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
General disorders
Injection site swelling
|
22.9%
156/682 • Number of events 190 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
18.0%
123/683 • Number of events 146 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
General disorders
Pyrexia
|
33.0%
225/682 • Number of events 349 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
34.4%
235/683 • Number of events 360 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Gastroenteritis
|
4.3%
29/682 • Number of events 32 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
6.0%
41/683 • Number of events 43 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
55/682 • Number of events 65 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
9.7%
66/683 • Number of events 76 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Otitis media
|
18.8%
128/682 • Number of events 177 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
18.7%
128/683 • Number of events 179 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Otitis media acute
|
8.2%
56/682 • Number of events 72 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
6.4%
44/683 • Number of events 57 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Pharyngitis
|
5.9%
40/682 • Number of events 47 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
5.1%
35/683 • Number of events 43 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Upper respiratory tract infection
|
23.3%
159/682 • Number of events 210 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
23.9%
163/683 • Number of events 212 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Infections and infestations
Viral infection
|
6.5%
44/682 • Number of events 52 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
8.3%
57/683 • Number of events 64 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
87/682 • Number of events 113 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
14.8%
101/683 • Number of events 118 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.5%
58/682 • Number of events 78 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
7.8%
53/683 • Number of events 64 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
9.1%
62/682 • Number of events 76 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
11.3%
77/683 • Number of events 106 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
48/682 • Number of events 50 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
6.9%
47/683 • Number of events 55 • Up to 6 months (180 days) after vaccination 2
The All Subjects as Treated population included randomized participants who received \>=1 dose of study vaccine and had safety follow-up results
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER