Trial · NCT02184572
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
NCT02184572, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age. Trials, record NCT02184572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02184572
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
- NCT number
- NCT02184572
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,742 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Measles; Mumps; Rubella, Measles-Mumps-Rubella Vaccine
- Interventions
- Priorix, M-M-R II, Varivax, Havrix, Prevnar 13
- First posted
- 2014-07-09
- Last updated
- 2021-01-07
- Other registries' IDs
- eudract:2011-006161-18
- Results first posted
- 2018-07-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination | During Day 5 to Day 12 post-vaccination period | Fever was assessed for temperature equal to/above (≥) 38.0°C and above (\>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV\_MMR minus COM\_MMR) in incidence of fever equal to or below the cut-off value. |
| Secondary | Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to \[≥\] 200 milli International Units per milliliter \[mIU/mL\] (Enzyme-Linked Immunosorbent Assay \[ELISA\], Enzygnost) among subjects who were seronegative (antibody concentration less than \[\<\] 150 mIU/mL) before vaccination. |
| Secondary | Anti-measles Virus Antibody Concentrations | At Day 42 post vaccination | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only. |
| Secondary | Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter \[EU/mL\] (ELISA, Pharmaceutical Product Development, Inc.\[PPD\]) among subjects who were seronegative (antibody concentration \< 5 EU/mL) before vaccination. |
| Secondary | Anti-mumps Virus Antibody Concentrations | At Day 42 post vaccination | Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only. |
| Secondary | Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter \[IU/mL\] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration \< 4 IU/mL) before vaccination. |
| Secondary | Anti-rubella Virus Antibody Concentrations | At Day 42 post vaccination | Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only. |
| Secondary | Number of Subjects With Any Solicited Local Adverse Events (AEs) | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects With Any Solicited General AEs | During the 15-day (Days 0-14) post-vaccination period | Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects Reporting Any Fever | During the 43-day (Days 0-42) post-vaccination period | Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to 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 | Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination | During Day 5 to Day 12 post-vaccination period | Analysis was performed on Total Vaccinated cohort (TVC) which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule. | Percentage of subjects | NUMBER |
| SECONDARY | Anti-measles Virus Antibody Concentrations | At Day 42 post vaccination | ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule. | mIU/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule. | Percentage of subjects | NUMBER |
| SECONDARY | Anti-mumps Virus Antibody Concentrations | At Day 42 post vaccination | According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps, or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule. | EU/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule. | Percentage of subjects | NUMBER |
| SECONDARY | Anti-rubella Virus Antibody Concentrations | At Day 42 post vaccination | ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule. | IU/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any Solicited Local Adverse Events (AEs) | During the 4-day (Days 0-3) post-vaccination period | Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Solicited General AEs | During the 15-day (Days 0-14) post-vaccination period | Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Any Fever | During the 43-day (Days 0-42) post-vaccination period | Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination | INV_MMR Group | > 39.0°C | 47 | Participants | |
| Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination | COM_MMR Group | > 39.0°C | 17 | Participants | |
| Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination | INV_MMR Group | ≥ 38.0°C | 205 | Participants | |
| Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination | COM_MMR Group | ≥ 38.0°C | 95 | Participants | |
| Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | INV_MMR Group | ≥ 150 mIU/mL | 99.3 | 95% Confidence Interval 98.6 to 99.7 | Percentage of subjects |
| Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | COM_MMR Group | ≥ 150 mIU/mL | 96.7 | 95% Confidence Interval 94.8 to 98.1 | Percentage of subjects |
| Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | INV_MMR Group | ≥ 200 mIU/mL | 99.0 | 95% Confidence Interval 98.2 to 99.5 | Percentage of subjects |
| Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | COM_MMR Group | ≥ 200 mIU/mL | 96.5 | 95% Confidence Interval 94.6 to 97.9 | Percentage of subjects |
| Anti-measles Virus Antibody Concentrations | INV_MMR Group | 2751.9 | 95% Confidence Interval 2618.3 to 2892.2 | mIU/mL | |
| Anti-measles Virus Antibody Concentrations | COM_MMR Group | 3133.3 | 95% Confidence Interval 2878.6 to 3410.6 | mIU/mL |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | INV_MMR | 1,164 | |
| Overall Study | STARTED | COM_MMR | 572 | |
| Overall Study | COMPLETED | INV_MMR | 1,117 | |
| Overall Study | COMPLETED | COM_MMR | 542 | |
| Overall Study | NOT COMPLETED | INV_MMR | 47 | |
| Overall Study | NOT COMPLETED | COM_MMR | 30 |
Source ClinicalTrials.gov
Adverse events104
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 | Diarrhoea | Gastrointestinal disorders | INV_MMR Group | 95 | 1,164 | 105 |
| other | Diarrhoea | Gastrointestinal disorders | COM_MMR Group | 46 | 572 | 53 |
| other | Teething | Gastrointestinal disorders | INV_MMR Group | 59 | 1,164 | 71 |
| other | Teething | Gastrointestinal disorders | COM_MMR Group | 15 | 572 | 17 |
| other | Injection site erythema | General disorders | INV_MMR Group | 284 | 1,164 | 297 |
| other | Injection site erythema | General disorders | COM_MMR Group | 143 | 572 | 149 |
| other | Injection site pain | General disorders | INV_MMR Group | 313 | 1,164 | 314 |
| other | Injection site pain | General disorders | COM_MMR Group | 133 | 572 | 133 |
| other | Injection site swelling | General disorders | INV_MMR Group | 105 | 1,164 | 108 |
| other | Injection site swelling | General disorders | COM_MMR Group | 61 | 572 | 62 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | INV_MMR Group | 0 | 1,164 |
| Total, all-cause mortality | COM_MMR Group | 0 | 572 |
| Total, other adverse events | INV_MMR Group | 980 | 1,164 |
| Total, other adverse events | COM_MMR Group | 477 | 572 |
| Total, serious adverse events | INV_MMR Group | 24 | 1,164 |
| Total, serious adverse events | COM_MMR Group | 9 | 572 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30118386 | BACKGROUND |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| INV_MMR Group vs COM_MMR Group: Number of Subjects Reporting Any Fever | Trial comparisons |
| INV_MMR vs COM_MMR: Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Trial comparisons |
| INV_MMR Group vs COM_MMR Group: Number of Subjects Reporting Any Unsolicited AEs | Trial comparisons |
| INV_MMR Group vs COM_MMR Group: deaths from any cause | Trial comparisons |
| INV_MMR Group vs COM_MMR Group: serious adverse events | 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.
GET https://conductscience.org/api/trials/v1/NCT02184572
GET https://conductscience.org/api/trials/v1/NCT02184572/results?page=2