A Phase 3 interventional study of MMRV (AMP) and MMRV (2006 process) in Measles, Mumps and Rubella, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 12 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention
This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 1,412 is above the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to
entering the study, or 2) any dose of systemic immunomodulatory steroids within
7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study
when the disease process has been stabilized
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Biological: MMRV (AMP)
Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process
Biological: MMRV (2006 process)
Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
Also known as: ProQuad™
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Time frame: Six weeks after vaccination 1
Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
Sera were tested for measles virus IgG antibody levels by an ELISA
Time frame: Six weeks after vaccination 1
Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
Time frame: Six weeks after vaccination 1
Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
Sera were tested for rubella virus IgG antibody levels by an ELISA
Time frame: Six weeks after vaccination 1
Geometric Mean Titer (GMT) of VZV Antibodies
Sera were tested for VZV IgG antibody levels by gpELISA
Time frame: Six weeks after vaccination 1
Geometric Mean Titer (GMT) of Measles Virus Antibodies
Sera were tested for measles virus IgG antibody levels by ELISA
Time frame: Six weeks after vaccination 1
Geometric Mean Titer (GMT) of Mumps Virus Antibodies
Sera were tested for mumps virus IgG antibody levels by ELISA
Time frame: Six weeks after vaccination 1
Geometric Mean Titer (GMT) of Rubella Virus Antibodies
Sera were tested for rubella virus IgG antibody levels by ELISA
Time frame: Six weeks after vaccination 1
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Time frame: Up to 5 days after vaccination 1
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Zoster-like Rash
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Mumps-like Symptoms
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Measles-like Rash
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Rubella-like Rash
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Varicella-like Rash
Time frame: Up to 42 days after each vaccination
Percentage of Participants With an Injection-site Adverse Event
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
| Milestone | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Started | 706 | 706 |
| Completed | 698 | 702 |
| Not completed | 8 | 4 |
| Withdrew: Not vaccinated | 8 | 4 |
| Milestone | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Started | 698 | 702 |
| Received vaccination 1 | 698 | 702 |
| Completed | 666 | 662 |
| Not completed | 32 | 40 |
| Withdrew: Withdrawal by subject | 12 | 18 |
| Withdrew: Lost to follow-up | 20 | 22 |
| Milestone | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Started | 666 | 662 |
| Completed | 635 | 634 |
| Not completed | 31 | 28 |
| Withdrew: Withdrawal by subject | 17 | 13 |
| Withdrew: Adverse event | 3 | 3 |
| Withdrew: Lost to follow-up | 9 | 10 |
| Withdrew: Protocol violation | 2 | 2 |
| Milestone | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Started | 635 | 634 |
| Received vaccination 2 | 634 | 632 |
| Completed | 615 | 618 |
| Not completed | 20 | 16 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 16 | 14 |
| Milestone | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Started | 615 | 618 |
| Completed | 595 | 595 |
| Not completed | 20 | 23 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 20 | 20 |
Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL | 97.3 (95.6 to 98.4) | 93.0 (90.7 to 95.0) |
Sera were tested for measles virus IgG antibody levels by an ELISA
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL | 96.7 (94.9 to 97.9) | 98.9 (97.7 to 99.5) |
Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL | 98.2 (96.8 to 99.1) | 97.2 (95.6 to 98.4) |
Sera were tested for rubella virus IgG antibody levels by an ELISA
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) | 98.8 (97.6 to 99.5) | 99.3 (98.3 to 99.8) |
Sera were tested for VZV IgG antibody levels by gpELISA
| ELISA units/mL | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Geometric Mean Titer (GMT) of VZV Antibodies | 17.3 (16.4 to 18.3) | 14.4 (13.6 to 15.2) |
Sera were tested for measles virus IgG antibody levels by ELISA
| mIU/mL | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Geometric Mean Titer (GMT) of Measles Virus Antibodies | 3426.5 (3162.5 to 3712.4) | 3719.5 (3506.0 to 3946.0) |
Sera were tested for mumps virus IgG antibody levels by ELISA
| Mumps Ab units/mL | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Geometric Mean Titer (GMT) of Mumps Virus Antibodies | 112.1 (104.1 to 120.7) | 114.0 (105.8 to 122.8) |
Sera were tested for rubella virus IgG antibody levels by ELISA
| IU/mL | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Geometric Mean Titer (GMT) of Rubella Virus Antibodies | 81.8 (76.8 to 87.2) | 80.7 (76.4 to 85.2) |
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) | 0.9 | 0.8 |
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Vaccination 1; n=650, n=649 | 10.0 | 10.6 |
| Vaccination 2; n=592, n=597 | 5.7 | 8.4 |
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Vaccination 1; n=682, n=682 | 0.0 | 0.0 |
| Vaccination 2; n=634, n=632 | 0.0 | 0.0 |
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Vaccination 1; n=682, n=682 | 0.0 | 0.0 |
| Vaccination 2; n=634, n=632 | 0.0 | 0.0 |
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Vaccination 1; n=682, n=682 | 0.1 | 0.3 |
| Vaccination 2; n=634, n=632 | 0.2 | 0.0 |
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Vaccination 1; n=682, n=682 | 0.0 | 0.0 |
| Vaccination 2; n=634, n=632 | 0.0 | 0.0 |
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Vaccination 1; n=682, n=682 | 0.6 | 0.0 |
| Vaccination 2; n=634, n=632 | 0.0 | 0.0 |
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.
| Percentage of participants | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Vaccination 1; n=682, n=682 | 36.4 | 29.8 |
| Vaccination 2; n=634, n=632 | 35.5 | 29.6 |
Collected over Up to 6 months (180 days) after vaccination 2. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MMRV (AMP) | — | 21/682 (3.1%) | 574/682 (84.2%) |
| MMRV (2006 Process) | — | 18/683 (2.6%) | 572/683 (83.7%) |
| Event | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Febrile convulsionNervous system disorders | 4/682 | 1/683 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/682 | 3/683 |
| GastroenteritisInfections and infestations | 2/682 | 0/683 |
| DehydrationMetabolism and nutrition disorders | 2/682 | 0/683 |
| BronchiolitisInfections and infestations | 1/682 | 2/683 |
| Croup infectiousInfections and infestations | 1/682 | 2/683 |
| Pneumonia viralInfections and infestations | 0/682 | 2/683 |
| Otitis mediaInfections and infestations | 1/682 | 0/683 |
| PneumoniaInfections and infestations | 1/682 | 0/683 |
| Respiratory syncytial virus bronchiolitisInfections and infestations | 1/682 | 0/683 |
| Event | MMRV (AMP) | MMRV (2006 Process) |
|---|---|---|
| Injection site erythemaGeneral disorders | 254/682 | 199/683 |
| PyrexiaGeneral disorders | 225/682 | 235/683 |
| Injection site painGeneral disorders | 208/682 | 187/683 |
| Upper respiratory tract infectionInfections and infestations | 159/682 | 163/683 |
| Injection site swellingGeneral disorders | 156/682 | 123/683 |
| Otitis mediaInfections and infestations | 128/682 | 128/683 |
| CoughRespiratory, thoracic and mediastinal disorders | 87/682 | 101/683 |
| DiarrhoeaGastrointestinal disorders | 77/682 | 91/683 |
| Dermatitis diaperSkin and subcutaneous tissue disorders | 62/682 | 77/683 |
| NasopharyngitisInfections and infestations | 55/682 | 66/683 |
| Age, Continuous(Months) | MMRV (AMP) | MMRV (2006 Process) | Total |
|---|---|---|---|
| Mean | 13.4 ± 2.2 | 13.6 ± 2.5 | 13.5 ± 2.3 |
| Sex: Female, Male(Participants) | MMRV (AMP) | MMRV (2006 Process) | Total |
|---|---|---|---|
| Female | 344 | 324 | 668 |
| Male | 362 | 382 | 744 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Jun 2012 to primary completion in Jul 2013, 12 months.
Results were first posted in Jul 2014, 1 year after primary completion.
Of 16 phase 3 interventional studies under Measles, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 24. This study's 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Adenosine Monophosphate