Trial · NCT01536405
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
NCT01536405, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2014-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027). Trials, record NCT01536405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01536405
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
- NCT number
- NCT01536405
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,412 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Measles, Mumps, Rubella, Varicella
- Interventions
- MMRV (AMP), MMRV (2006 process)
- First posted
- 2012-02-22
- Last updated
- 2018-10-31
- Results first posted
- 2014-07-02
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL | Six weeks after vaccination 1 | Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA) |
| Primary | Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL | Six weeks after vaccination 1 | Sera were tested for measles virus IgG antibody levels by an ELISA |
| Primary | Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL | Six weeks after vaccination 1 | Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA) |
| Primary | Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) | Six weeks after vaccination 1 | Sera were tested for rubella virus IgG antibody levels by an ELISA |
| Primary | Geometric Mean Titer (GMT) of VZV Antibodies | Six weeks after vaccination 1 | Sera were tested for VZV IgG antibody levels by gpELISA |
| Primary | Geometric Mean Titer (GMT) of Measles Virus Antibodies | Six weeks after vaccination 1 | Sera were tested for measles virus IgG antibody levels by ELISA |
| Primary | Geometric Mean Titer (GMT) of Mumps Virus Antibodies | Six weeks after vaccination 1 | Sera were tested for mumps virus IgG antibody levels by ELISA |
| Primary | Geometric Mean Titer (GMT) of Rubella Virus Antibodies | Six weeks after vaccination 1 | Sera were tested for rubella virus IgG antibody levels by ELISA |
| Primary | Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) | Up to 5 days after vaccination 1 | |
| Secondary | Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) | Up to 42 days after each vaccination |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL | Six weeks after vaccination 1 | The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL | Six weeks after vaccination 1 | The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL | Six weeks after vaccination 1 | The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) | Six weeks after vaccination 1 | The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results | Percentage of participants | NUMBER |
| PRIMARY | Geometric Mean Titer (GMT) of VZV Antibodies | Six weeks after vaccination 1 | The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results | ELISA units/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer (GMT) of Measles Virus Antibodies | Six weeks after vaccination 1 | The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results | mIU/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer (GMT) of Mumps Virus Antibodies | Six weeks after vaccination 1 | The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results | Mumps Ab units/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titer (GMT) of Rubella Virus Antibodies | Six weeks after vaccination 1 | The per protocol population included participants who received \>=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results | IU/mL | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) | Up to 5 days after vaccination 1 | The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) | Up to 42 days after each vaccination | The population analyzed included participants who received \>=1 study vaccination and had follow-up safety data | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL | MMRV (AMP) | 97.3 | 95% Confidence Interval 95.6 to 98.4 | Percentage of participants | |
| Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL | MMRV (2006 Process) | 93.0 | 95% Confidence Interval 90.7 to 95.0 | Percentage of participants | |
| Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL | MMRV (AMP) | 96.7 | 95% Confidence Interval 94.9 to 97.9 | Percentage of participants | |
| Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL | MMRV (2006 Process) | 98.9 | 95% Confidence Interval 97.7 to 99.5 | Percentage of participants | |
| Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL | MMRV (AMP) | 98.2 | 95% Confidence Interval 96.8 to 99.1 | Percentage of participants | |
| Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL | MMRV (2006 Process) | 97.2 | 95% Confidence Interval 95.6 to 98.4 | Percentage of participants | |
| Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) | MMRV (AMP) | 98.8 | 95% Confidence Interval 97.6 to 99.5 | Percentage of participants | |
| Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) | MMRV (2006 Process) | 99.3 | 95% Confidence Interval 98.3 to 99.8 | Percentage of participants | |
| Geometric Mean Titer (GMT) of VZV Antibodies | MMRV (AMP) | 17.3 | 95% Confidence Interval 16.4 to 18.3 | ELISA units/mL | |
| Geometric Mean Titer (GMT) of VZV Antibodies | MMRV (2006 Process) | 14.4 | 95% Confidence Interval 13.6 to 15.2 | ELISA units/mL |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow34
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization to Visit 1 (Vaccination 1) | STARTED | MMRV (AMP) | 706 | |
| Randomization to Visit 1 (Vaccination 1) | STARTED | MMRV (2006 Process) | 706 | |
| Randomization to Visit 1 (Vaccination 1) | COMPLETED | MMRV (AMP) | 698 | |
| Randomization to Visit 1 (Vaccination 1) | COMPLETED | MMRV (2006 Process) | 702 | |
| Randomization to Visit 1 (Vaccination 1) | NOT COMPLETED | MMRV (AMP) | 8 | |
| Randomization to Visit 1 (Vaccination 1) | NOT COMPLETED | MMRV (2006 Process) | 4 | |
| Visit 1 (Vaccination 1) to Visit 2 | STARTED | MMRV (AMP) | 698 | |
| Visit 1 (Vaccination 1) to Visit 2 | STARTED | MMRV (2006 Process) | 702 | |
| Visit 1 (Vaccination 1) to Visit 2 | Received Vaccination 1 | MMRV (AMP) | 698 | |
| Visit 1 (Vaccination 1) to Visit 2 | Received Vaccination 1 | MMRV (2006 Process) | 702 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 participant flowAdverse events108
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis | Eye disorders | MMRV (AMP) | 48 | 682 | 52 |
| other | Conjunctivitis | Eye disorders | MMRV (2006 Process) | 46 | 683 | 47 |
| other | Diarrhoea | Gastrointestinal disorders | MMRV (AMP) | 77 | 682 | 98 |
| other | Diarrhoea | Gastrointestinal disorders | MMRV (2006 Process) | 91 | 683 | 107 |
| other | Vomiting | Gastrointestinal disorders | MMRV (AMP) | 60 | 682 | 77 |
| other | Vomiting | Gastrointestinal disorders | MMRV (2006 Process) | 61 | 683 | 72 |
| other | Injection site erythema | General disorders | MMRV (AMP) | 254 | 682 | 344 |
| other | Injection site erythema | General disorders | MMRV (2006 Process) | 199 | 683 | 258 |
| other | Injection site pain | General disorders | MMRV (AMP) | 208 | 682 | 267 |
| other | Injection site pain | General disorders | MMRV (2006 Process) | 187 | 683 | 243 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MMRV (AMP) | ||
| Total, all-cause mortality | MMRV (2006 Process) | ||
| Total, other adverse events | MMRV (AMP) | 574 | 682 |
| Total, other adverse events | MMRV (2006 Process) | 572 | 683 |
| Total, serious adverse events | MMRV (AMP) | 21 | 682 |
| Total, serious adverse events | MMRV (2006 Process) | 18 | 683 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27149048 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MMRV (AMP) vs MMRV (2006 Process): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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