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CompletedNCT01702428Updated Nov 25, 2019Results posted

Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age

A Phase 3 interventional study of Priorix and M-M-R II in Rubella, Measles and Mumps, sponsored by GlaxoSmithKline. Completed at 90 sites in 6 countries. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
5,016
Allocation
Randomized
Ages
12 Months to 15 Months
Sex
All
01

Study summary

The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).

Read the detailed description

This study will evaluate the consistency of the immune response to three different lots of GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine, throughout this document) and compare its immunogenicity to the US standard of care comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as COM_MMR throughout this document) in children during their second year of life. The INV_MMR vaccine will be given as one of three consistency lots manufactured to target potencies designated as INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.

02

Conditions studied

  • Rubella
  • Measles
  • Mumps

Keywords

  • Safety
  • Consistency study
  • Measles, mumps and rubella diseases
  • Healthy children
  • Immunogenicity
03

In context

Rubella

85 studies on the registry are indexed under Rubella; 11 are open to participants now.

This study's enrollment of 5,016 is above the median of 801 across 71 interventional studies indexed under Rubella.

Browse Rubella studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Male or female child between 12 and 15 months of age at the time of vaccination.
  • The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol.
  • Written obtained from the parent(s)/LAR(s) of the child.
  • Child is in stable health as determined by investigator's clinical examination and assessment of child's medical history.

For US children only:

  • Child that previously received a 3-dose series of Prevnar 13 only (i.e., no doses given as Prevnar/Prevenar), with the last dose at least 60 days prior to study entry.

Exclusion criteria

Exclusion Criteria:

  • Child in care.
  • Use of any or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study period.
  • Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.

  • Chronic administration of , or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.

    • For , this will mean prednisone, ≥0.5 mg/kg/day or equivalent.
    • Inhaled and topical steroids are allowed.

  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2. Please Note:

    • Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
    • Any other age appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
  • Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
  • History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to first study vaccination.
  • Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including to neomycin, latex or gelatin.
  • Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
  • Active untreated tuberculosis based on medical history.
  • Any other condition which, in the opinion of the investigator, prevents the child from participating in the study.

For US children only:

  • Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior vaccination should be with 3 doses of Prevnar 13 only).
  • Child that previously received a fourth dose of any pneumococcal conjugate vaccine.
Terms in these criteria, in plain language(5)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
5,016 participants (actual)

Study arms

  • Experimental
    INV_MMR_L1 Group

    Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Biological: Priorix · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13

  • Experimental
    INV_MMR_L2 Group

    Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Biological: Priorix · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13

  • Experimental
    INV_MMR_L3 Group

    Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Biological: Priorix · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13

  • Active comparator
    COM_MMR Group

    Subjects receive 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis is conducted for this group.

    Biological: M-M-R II · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13

Interventions

  • BiologicalPriorix

    Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.

    Also known as: GSK Biologicals' live attenuated measles, mumps and rubella vaccine (GSK209762)

  • BiologicalM-M-R II

    Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.

  • BiologicalVarivax

    Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.

  • BiologicalHavrix

    Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.

  • BiologicalPrevnar 13

    US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value

    Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

    Time frame: At Day 42

  2. Anti-measles Virus Antibody Concentrations

    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

    Time frame: At Day 42

  3. Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value

    Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations \<5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

    Time frame: At Day 42

  4. Anti-mumps Virus Antibody Concentration

    Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

    Time frame: At Day 42

  5. Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value

    Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations \<4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

    Time frame: At Day 42

  6. Anti-rubella Virus Antibody Concentration

    Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

    Time frame: At Day 42

  7. Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

    Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.

    Time frame: At Day 42

  8. Anti-measles Virus Antibody Concentrations in Pooled MMR Groups

    Antibody concentrations were expressed as GMCs in mIU/mL.

    Time frame: At Day 42

  9. Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

    Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations \<5 EU/mL) before vaccination.

    Time frame: At Day 42

  10. Anti-mumps Virus Antibody Concentration in Pooled MMR Groups

    Antibody concentrations were expressed as GMCs in EU/mL.

    Time frame: At Day 42

  11. Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

    Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations \<4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.

    Time frame: At Day 42

  12. Anti-rubella Virus Antibody Concentration in Pooled MMR Groups

    Antibody concentrations were expressed as GMCs in IU/mL.

    Time frame: At Day 42

Secondary outcomes

  1. Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups

    Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration \<25 mIU/mL) before vaccination.

    Time frame: At Day 42

  2. Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups

    Antibody concentrations were expressed as GMCs in mIU/mL.

    Time frame: At Day 42

  3. Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups

    Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.

    Time frame: At Day 42

  4. Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups

    Antibody concentrations were expressed as GMCs in mIU/mL.

    Time frame: At Day 42

  5. Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups

    Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).

    Time frame: At Day 42

  6. Number of Subjects With Any Solicited Local Adverse Events (AEs)

    Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

    Time frame: During the 4-days (Days 0-3) post-vaccination period

  7. Number of Subjects With Any Solicited General AEs

    Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

    Time frame: During the 15-days (Days 0-14) post-vaccination period

  8. Number of Subjects Reporting Any Fever

    Any fever = Fever ≥ 38°C.

    Time frame: During the 43-days (Days 0-42) post-vaccination period

  9. Number of Subjects Reporting Any Rash

    Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

    Time frame: During the 43-days (Days 0-42) post-vaccination period

  10. Number of Subjects Reporting Any MMR Specific Solicited AEs

    Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

    Time frame: During the 43-days (Days 0-42) post-vaccination period

  11. Number of Subjects Reporting Any Unsolicited AEs

    Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

    Time frame: During the 43-days (Days 0-42) post-vaccination period

  12. Number of Subjects Reporting AEs of Specific Interest

    AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.

    Time frame: From Day 0 through the end of study (Day 180)

  13. Number of Subjects Reporting Any Serious Adverse Events (SAEs)

    SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.

    Time frame: From Day 0 through the end of study (Day 180)

07

Results

Posted Jun 28, 2018

Participant flow

13 subjects from 5016 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started is 5003.

Participant flow — Overall Study
MilestoneINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupCOM_MMR Group
Started1239123212431289
Completed1175116211901232
Not completed64705357
Withdrew: Adverse event2000
Withdrew: Lost to follow-up33413744
Withdrew: Parents cannot assist to site1010
Withdrew: Lost coverage0001
Withdrew: Lost health plan3502
Withdrew: Mother transferred care0100
Withdrew: Parents too busy1000
Withdrew: Protocol violation3010
Withdrew: Withdrawal by subject21231410

Outcome measures

PrimaryPercentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value

Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Time frame:
At Day 42
Reported as:
Number · Percentage of subjects
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Percentage of subjectsINV_MMR _L1 GroupINV_MMR _L2 GroupINV_MMR _L3 Group
Anti-measles ≥ 150 mIU/mL98.2 (97.3 to 98.9)98.9 (98.0 to 99.4)98.1 (97.1 to 98.8)
Anti-measles ≥ 200 mIU/mL98.1 (97.1 to 98.8)98.6 (97.7 to 99.2)97.8 (96.8 to 98.6)
Statistical analysis
  • INV_MMR _L1 Group vs INV_MMR _L2 Group · Difference in seroresponse rate: -0.54 · 95% CI -1.69 to 0.58Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
  • INV_MMR _L2 Group vs INV_MMR _L3 Group · Difference in seroresponse rate: 0.79 · 95% CI -0.35 to 1.98Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
  • INV_MMR _L1 Group vs INV_MMR _L3 Group · Difference in seroresponse rate: 0.25 · 95% CI -0.98 to 1.50Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
PrimaryAnti-measles Virus Antibody Concentrations

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Time frame:
At Day 42
Reported as:
Geometric mean · mIU/mL
Anti-measles Virus Antibody Concentrations
mIU/mLINV_MMR _L1 GroupINV_MMR _L2 GroupINV_MMR _L3 Group
Anti-measles Virus Antibody Concentrations2970.3 (2813.2 to 3136.2)3023.6 (2864.5 to 3191.6)3058.3 (2893.9 to 3232.0)
Statistical analysis
  • INV_MMR _L1 Group vs INV_MMR _L2 Group · ANOVA · Adjusted gmc ratio: 0.99 · 95% CI 0.91 to 1.0695% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR _L1 Group vs INV_MMR _L3 Group · ANOVA · Adjusted gmc ratio: 0.97 · 95% CI 0.90 to 1.0595% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR _L1 Group vs INV_MMR _L2 Group · ANOVA · Adjusted gmc ratio: 1.01 · 95% CI 0.94 to 1.0995% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR _L2 Group vs INV_MMR _L3 Group · ANOVA · Adjusted gmc ratio: 0.99 · 95% CI 0.91 to 1.0695% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR _L1 Group vs INV_MMR _L3 Group · ANOVA · Adjusted gmc ratio: 1.03 · 95% CI 0.95 to 1.1195% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR _L2 Group vs INV_MMR _L3 Group · ANOVA · Adjusted gmc ratio: 1.01 · 95% CI 0.94 to 1.0995% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
PrimaryPercentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value

Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations \<5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Time frame:
At Day 42
Reported as:
Number · Percentage of subjects
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
Percentage of subjectsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 Group
Anti-mumps ≥ 5 EU/mL99.7 (99.2 to 99.9)99.3 (98.6 to 99.7)99.2 (98.4 to 99.6)
Anti-mumps ≥ 10 EU/mL98.6 (97.7 to 99.2)98.6 (97.6 to 99.2)98.0 (96.9 to 98.7)
Statistical analysis
  • INV_MMR_L1 Group vs INV_MMR_L2 Group · Difference in seroresponse rate: 0.02 · 95% CI -1.05 to 1.09Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
  • INV_MMR_L1 Group vs INV_MMR_L3 Group · Difference in seroresponse rate: 0.63 · 95% CI -0.50 to 1.81Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
  • INV_MMR_L2 Group vs INV_MMR_L3 Group · Difference in seroresponse rate: 0.61 · 95% CI -0.53 to 1.79Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
PrimaryAnti-mumps Virus Antibody Concentration

Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Time frame:
At Day 42
Reported as:
Geometric mean · EU/mL
Anti-mumps Virus Antibody Concentration
EU/mLINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 Group
Anti-mumps Virus Antibody Concentration71.7 (68.3 to 75.2)76.9 (73.2 to 80.8)69.0 (65.5 to 72.7)
Statistical analysis
  • INV_MMR_L1 Group vs INV_MMR_L2 Group · ANOVA · Adjusted gmc ratio: 0.93 · 95% CI 0.87 to 1.0095% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L1 Group vs INV_MMR_L3 Group · ANOVA · Adjusted gmc ratio: 1.04 · 95% CI 0.97 to 1.1195% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L1 Group vs INV_MMR_L2 Group · ANOVA · Adjusted gmc ratio: 1.07 · 95% CI 1.00 to 1.1595% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L2 Group vs INV_MMR_L3 Group · ANOVA · Adjusted gmc ratio: 1.11 · 95% CI 1.04 to 1.1995% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L1 Group vs INV_MMR_L3 Group · ANOVA · Adjusted gmc ratio: 0.96 · 95% CI 0.90 to 1.0395% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L2 Group vs INV_MMR_L3 Group · ANOVA · Adjusted gmc ratio: 0.90 · 95% CI 0.84 to 0.9695% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
PrimaryPercentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value

Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations \<4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Time frame:
At Day 42
Reported as:
Number · Percentage of subjects
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
Percentage of subjectsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 Group
Anti-rubella ≥ 4 IU/mL99.4 (98.8 to 99.8)99.7 (99.2 to 99.9)99.4 (98.7 to 99.7)
Anti-rubella ≥ 10 IU/mL97.2 (96.1 to 98.1)97.1 (95.9 to 98.0)97.7 (96.6 to 98.5)
Statistical analysis
  • INV_MMR_L1 Group vs INV_MMR_L2 Group · Difference in seroresponse rate: 0.14 · 95% CI -1.3 to 1.58Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
  • INV_MMR_L1 Group vs INV_MMR_L3 Group · Difference in seroresponse rate: -0.49 · 95% CI -1.86 to 0.86Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
  • INV_MMR_L2 Group vs INV_MMR_L3 Group · Difference in seroresponse rate: -0.62 · 95% CI -2.02 to 0.74Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
PrimaryAnti-rubella Virus Antibody Concentration

Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Time frame:
At Day 42
Reported as:
Geometric mean · IU/mL
Anti-rubella Virus Antibody Concentration
IU/mLINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 Group
Anti-rubella Virus Antibody Concentration57.2 (54.4 to 60.1)53.1 (50.5 to 55.7)57.0 (54.3 to 59.8)
Statistical analysis
  • INV_MMR_L1 Group vs INV_MMR_L2 Group · ANOVA · Adjusted gmc ratio: 1.08 · 95% CI 1.01 to 1.1595% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L1 Group vs INV_MMR_L3 Group · ANOVA · Adjusted gmc ratio: 1.00 · 95% CI 0.94 to 1.0795% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L1 Group vs INV_MMR_L2 Group · ANOVA · Adjusted gmc ratio: 0.93 · 95% CI 0.87 to 0.9995% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L2 Group vs INV_MMR_L3 Group · ANOVA · Adjusted gmc ratio: 0.93 · 95% CI 0.87 to 0.9995% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L1 Group vs INV_MMR_L3 Group · ANOVA · Adjusted gmc ratio: 1.00 · 95% CI 0.93 to 1.0795% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
  • INV_MMR_L2 Group vs INV_MMR_L3 Group · ANOVA · Adjusted gmc ratio: 1.08 · 95% CI 1.01 to 1.1595% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups \& country as fixed effects) on log-transformed concentrations.
PrimaryPercentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.

Time frame:
At Day 42
Reported as:
Number · Percentage of subjects
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Percentage of subjectsINV_MMR GroupCOM_MMR Group
Anti-measles ≥ 150 mIU/mL98.4 (97.9 to 98.8)98.1 (97.1 to 98.8)
Anti-measles ≥ 200 mIU/mL98.2 (97.6 to 98.6)98.0 (97.0 to 98.7)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · Difference in seroresponse rate: 0.18 · 95% CI -0.68 to 1.25Asymptotic standardized 95% CIs for the difference in seroresponse rate.
PrimaryAnti-measles Virus Antibody Concentrations in Pooled MMR Groups

Antibody concentrations were expressed as GMCs in mIU/mL.

Time frame:
At Day 42
Reported as:
Geometric mean · mIU/mL
Anti-measles Virus Antibody Concentrations in Pooled MMR Groups
mIU/mLINV_MMR GroupCOM_MMR Group
Anti-measles Virus Antibody Concentrations in Pooled MMR Groups3017.4 (2923.9 to 3113.8)3074.4 (2911.0 to 3246.9)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · ANOVA · Adjusted gmc ratio: 0.98 · 95% CI 0.93 to 1.0595% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.
PrimaryPercentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations \<5 EU/mL) before vaccination.

Time frame:
At Day 42
Reported as:
Number · Percentage of subjects
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Percentage of subjectsINV_MMR GroupCOM_MMR Group
Anti-mumps ≥ 5 EU/mL99.4 (99.1 to 99.6)99.3 (98.6 to 99.7)
Anti-mumps ≥ 10 EU/mL98.4 (97.9 to 98.8)97.6 (96.5 to 98.4)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · Difference in seroresponse rate: 0.81 · 95% CI -0.1 to 1.96Asymptotic standardized 95% CIs for the difference in seroresponse rate.
PrimaryAnti-mumps Virus Antibody Concentration in Pooled MMR Groups

Antibody concentrations were expressed as GMCs in EU/mL.

Time frame:
At Day 42
Reported as:
Geometric mean · EU/mL
Anti-mumps Virus Antibody Concentration in Pooled MMR Groups
EU/mLINV_MMR GroupCOM_MMR Group
Anti-mumps Virus Antibody Concentration in Pooled MMR Groups72.4 (70.4 to 74.5)69.1 (65.7 to 72.7)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · ANOVA · Adjusted gmc ratio: 1.05 · 95% CI 0.99 to 1.1195% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.
PrimaryPercentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations \<4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.

Time frame:
At Day 42
Reported as:
Number · Percentage of subjects
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Percentage of subjectsINV_MMR GroupCOM_MMR Group
Anti-rubella ≥ 4 IU/mL99.5 (99.2 to 99.7)99.6 (99.0 to 99.9)
Anti-rubella ≥ 10 IU/mL97.3 (96.7 to 97.9)98.5 (97.6 to 99.1)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · Difference in seroresponse rate: -1.15 · 95% CI -2.00 to -0.15Asymptotic standardized 95% CIs for the difference in seroresponse rate.
PrimaryAnti-rubella Virus Antibody Concentration in Pooled MMR Groups

Antibody concentrations were expressed as GMCs in IU/mL.

Time frame:
At Day 42
Reported as:
Geometric mean · IU/mL
Anti-rubella Virus Antibody Concentration in Pooled MMR Groups
IU/mLINV_MMR GroupCOM_MMR Group
Anti-rubella Virus Antibody Concentration in Pooled MMR Groups55.7 (54.2 to 57.3)64.0 (61.1 to 67.0)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · ANOVA · Adjusted gmc ratio: 0.87 · 95% CI 0.83 to 0.9295% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.
SecondaryPercentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups

Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration \<25 mIU/mL) before vaccination.

Time frame:
At Day 42
Reported as:
Number · Percentage of subjects
Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
Percentage of subjectsINV_MMR GroupCOM_MMR Group
Anti-VZV ≥ 25 mIU/mL99.7 (99.3 to 99.9)99.6 (98.7 to 100)
Anti-VZV ≥ 75 mIU/mL92.2 (90.7 to 93.5)90.9 (88.2 to 93.2)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · Difference in seroresponse rate: 1.30 · 95% CI -1.31 to 4.29Asymptotic standardized 95% CIs for the difference in seroresponse rate.
SecondaryAnti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups

Antibody concentrations were expressed as GMCs in mIU/mL.

Time frame:
At Day 42
Reported as:
Geometric mean · mIU/mL
Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups
mIU/mLINV_MMR GroupCOM_MMR Group
Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups169.6 (164.3 to 175)167.2 (158.2 to 176.7)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · ANOVA · Adjusted gmc ratio: 1.01 · 95% CI 0.95 to 1.0895% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.
SecondaryPercentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups

Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.

Time frame:
At Day 42
Reported as:
Number · Percentage of subjects
Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
Percentage of subjectsINV_MMR GroupCOM_MMR Group
Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups88.9 (86.5 to 91.0)87.4 (82.9 to 91.0)
SecondaryAnti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups

Antibody concentrations were expressed as GMCs in mIU/mL.

Time frame:
At Day 42
Reported as:
Geometric mean · mIU/mL
Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups
mIU/mLINV_MMR GroupCOM_MMR Group
Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups42.0 (39.3 to 44.8)42.4 (38.1 to 47.2)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · ANOVA · Adjusted gmc ratio: 0.98 · 95% CI 0.86 to 1.1195% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.
SecondaryAnti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups

Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).

Time frame:
At Day 42
Reported as:
Geometric mean · µg/mL
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups
µg/mLINV_MMR GroupCOM_MMR Group
anti-PnPS 1 antibody2.257 (2.121 to 2.402)2.425 (2.195 to 2.679)
anti-PnPS 3 antibody0.506 (0.481 to 0.533)0.496 (0.454 to 0.542)
anti-PnPS 4 antibody1.618 (1.518 to 1.725)1.872 (1.676 to 2.091)
anti-PnPS 5 antibody2.106 (1.991 to 2.228)2.280 (2.085 to 2.493)
anti-PnPS 6A antibody5.840 (5.508 to 6.192)5.743 (5.233 to 6.304)
anti-PnPS 6B antibody5.872 (5.504 to 6.265)5.838 (5.239 to 6.505)
anti-PnPS 7F antibody3.691 (3.489 to 3.905)3.814 (3.484 to 4.176)
anti-PnPS 9V antibody2.318 (2.183 to 2.461)2.282 (2.065 to 2.521)
anti-PnPS 14 antibody6.578 (6.155 to 7.029)7.053 (6.368 to 7.811)
anti-PnPS 18C antibody2.102 (1.973 to 2.241)2.217 (1.990 to 2.470)
anti-PnPS 19A antibody4.731 (4.461 to 5.017)4.821 (4.372 to 5.317)
anti-PnPS 19F antibody4.251 (4.013 to 4.504)4.260 (3.872 to 4.687)
anti-PnPS 23F antibody2.198 (2.051 to 2.355)2.291 (2.025 to 2.592)
Statistical analysis
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.94 · 95% CI 0.85 to 1.0595% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.99 · 95% CI 0.91 to 1.0895% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.88 · 95% CI 0.79 to 0.9895% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.92 · 95% CI 0.83 to 1.0195% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 1.01 · 95% CI 0.92 to 1.1195% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.98 · 95% CI 0.89 to 1.0995% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.94 · 95% CI 0.86 to 1.0395% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.99 · 95% CI 0.90 to 1.0895% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.91 · 95% CI 0.81 to 1.0295% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.92 · 95% CI 0.84 to 1.0295% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.97 · 95% CI 0.87 to 1.0795% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.96 · 95% CI 0.87 to 1.0695% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
  • INV_MMR Group vs COM_MMR Group · ANCOVA · Adjusted gmc ratio: 0.95 · 95% CI 0.85 to 1.0695% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
SecondaryNumber of Subjects With Any Solicited Local Adverse Events (AEs)

Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

Time frame:
During the 4-days (Days 0-3) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs)
ParticipantsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
Any Pain331315273919349
Any Redness296273301870313
Any Swelling11699103318133
SecondaryNumber of Subjects With Any Solicited General AEs

Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

Time frame:
During the 15-days (Days 0-14) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Any Solicited General AEs
ParticipantsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
Any Drowsiness5335355331601586
Any Irritability/fussiness7647297652258819
Any Loss of appetite5465365261608548
SecondaryNumber of Subjects Reporting Any Fever

Any fever = Fever ≥ 38°C.

Time frame:
During the 43-days (Days 0-42) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Fever
ParticipantsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
Number of Subjects Reporting Any Fever4044224181244412
SecondaryNumber of Subjects Reporting Any Rash

Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

Time frame:
During the 43-days (Days 0-42) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Rash
ParticipantsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
Any Localized or Generalized3523313601043378
Any with fever106123118347104
Any Varicella like87788525085
Any Measles/Rubella like71887623577
SecondaryNumber of Subjects Reporting Any MMR Specific Solicited AEs

Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

Time frame:
During the 43-days (Days 0-42) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any MMR Specific Solicited AEs
ParticipantsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
Any febrile convulsion415103
Any parotid/salivary gland swelling00000
SecondaryNumber of Subjects Reporting Any Unsolicited AEs

Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

Time frame:
During the 43-days (Days 0-42) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Unsolicited AEs
ParticipantsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
Number of Subjects Reporting Any Unsolicited AEs6156336091857618
SecondaryNumber of Subjects Reporting AEs of Specific Interest

AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.

Time frame:
From Day 0 through the end of study (Day 180)
Reported as:
Count of participants · Participants
Number of Subjects Reporting AEs of Specific Interest
ParticipantsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
NOCDs40394912848
AEs prompting ER visits123116136375134
SecondaryNumber of Subjects Reporting Any Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.

Time frame:
From Day 0 through the end of study (Day 180)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
ParticipantsINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
Number of Subjects Reporting Any Serious Adverse Events (SAEs)2128287725

Adverse events

Collected over Serious Adverse Events: From Day 0 through the end of study (Day-180); Solicited local and general symptoms: During the 4-day (Day 0-3) and 15-days (Day 0-14) post-vaccination period; Unsolicited adverse events: During the 43-days (Day 0-42) post-vaccination period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
INV_MMR_L1 Group0/1,239 (0%)21/1,239 (1.7%)1,089/1,239 (87.9%)
INV_MMR_L2 Group0/1,232 (0%)28/1,232 (2.3%)1,053/1,232 (85.5%)
INV_MMR_L3 Group0/1,243 (0%)28/1,243 (2.3%)1,090/1,243 (87.7%)
INV_MMR Group0/3,714 (0%)77/3,714 (2.1%)3,232/3,714 (87%)
COM_MMR Group0/1,289 (0%)25/1,289 (1.9%)1,138/1,289 (88.3%)
Most frequent serious events
Showing 10 of 57
Most frequent serious events
EventINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
Febrile convulsionNervous system disorders0/12390/12321/12431/37145/1289
Otitis mediaInfections and infestations0/12390/12324/12434/37142/1289
Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders0/12393/12320/12433/37143/1289
BronchitisInfections and infestations3/12392/12323/12438/37142/1289
PneumoniaInfections and infestations2/12391/12323/12436/37140/1289
DehydrationMetabolism and nutrition disorders0/12392/12323/12435/37143/1289
Viral infectionInfections and infestations0/12390/12322/12432/37143/1289
BronchiolitisInfections and infestations1/12392/12321/12434/37142/1289
Pneumonia viralInfections and infestations1/12392/12321/12434/37140/1289
AsthmaRespiratory, thoracic and mediastinal disorders2/12392/12320/12434/37142/1289
Most frequent other events
Showing 10 of 297
Most frequent other events
EventINV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupINV_MMR GroupCOM_MMR Group
IrritabilityPsychiatric disorders765/1239730/1232768/12432263/3714822/1289
SomnolenceNervous system disorders534/1239535/1232533/12431602/3714586/1289
Decreased appetiteMetabolism and nutrition disorders547/1239537/1232526/12431610/3714549/1289
PyrexiaGeneral disorders405/1239422/1232419/12431246/3714412/1289
RashSkin and subcutaneous tissue disorders352/1239331/1232360/12431043/3714378/1289
Injection site painGeneral disorders335/1239316/1232275/1243926/3714352/1289
Injection site erythemaGeneral disorders321/1239294/1232328/1243943/3714335/1289
Injection site swellingGeneral disorders127/1239106/1232113/1243346/3714139/1289
Upper respiratory tract infectionInfections and infestations106/1239124/1232122/1243352/3714122/1289
TeethingGastrointestinal disorders91/123992/123277/1243260/371495/1289

Baseline characteristics

Age, Continuous
Age, Continuous(Months)INV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupCOM_MMR GroupTotal
Mean12.3 ± 0.712.3 ± 0.712.3 ± 0.712.3 ± 0.712.3 ± 0.7
Sex: Female, Male
Sex: Female, Male(Participants)INV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupCOM_MMR GroupTotal
Female6075946156182434
Male6326386286712569
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)INV_MMR_L1 GroupINV_MMR_L2 GroupINV_MMR_L3 GroupCOM_MMR GroupTotal
White - Arabic / North African Heritage562720
Asian - Central/South Asian Heritage1467936
Other170155162163650
Native Hawaiian or Other Pacific Islander315211
American Indian or Alaskan Native25373331126
White - Caucasian / European Heritage9329389449703784
Asian - South East Asian Heritage2125212693
African Heritage / African American60525770239
Asian - Japanese Heritage12216
Asian - East Asian Heritage810101038
08

Study locations

90 sites
  • GSK Investigational Site
    Dothan, Alabama 36305, United States
  • GSK Investigational Site
    Phoenix, Arizona 85048, United States
  • GSK Investigational Site
    Fayetteville, Arkansas 72703, United States
  • GSK Investigational Site
    Anaheim, California 92804, United States
  • GSK Investigational Site
    Daly City, California 94015, United States
  • GSK Investigational Site
    Fresno, California 93726, United States
  • GSK Investigational Site
    Hayward, California 94545, United States
  • GSK Investigational Site
    Los Gatos, California 95032, United States
  • GSK Investigational Site
    Mission Hills, California 91345, United States
  • GSK Investigational Site
    Paramount, California 90723, United States
  • GSK Investigational Site
    Pleasanton, California 94588, United States
  • GSK Investigational Site
    Sacramento, California 95815, United States
  • GSK Investigational Site
    Sacramento, California 95823, United States
  • GSK Investigational Site
    Santa Clara, California 95051, United States
  • GSK Investigational Site
    Walnut Creek, California 94596, United States
  • GSK Investigational Site
    Colorado Springs, Colorado 80920, United States
  • GSK Investigational Site
    Colorado Springs, Colorado 80922, United States
  • GSK Investigational Site
    Nampa, Idaho 83686, United States
  • GSK Investigational Site
    Evergreen Park, Illinois 60805, United States
  • GSK Investigational Site
    Ames, Iowa 50010, United States
  • GSK Investigational Site
    Augusta, Kansas 67010, United States
  • GSK Investigational Site
    Overland Park, Kansas 66213, United States
  • GSK Investigational Site
    Topeka, Kansas 66604, United States
  • GSK Investigational Site
    Louisville, Kentucky 40202, United States
  • GSK Investigational Site
    Bossier City, Louisiana 71111, United States
  • GSK Investigational Site
    Columbia, Maryland 21045, United States
  • GSK Investigational Site
    Boston, Massachusetts 02130, United States
  • GSK Investigational Site
    Fall River, Massachusetts 02721, United States
  • GSK Investigational Site
    Niles, Michigan 49120, United States
  • GSK Investigational Site
    Stevensville, Michigan 49127, United States
  • GSK Investigational Site
    Kansas City, Missouri 64114, United States
  • GSK Investigational Site
    Bronx, New York 10467, United States
  • GSK Investigational Site
    Ithaca, New York 14850, United States
  • GSK Investigational Site
    Syracuse, New York 13210, United States
  • GSK Investigational Site
    Cincinnati, Ohio 45245, United States
  • GSK Investigational Site
    Cleveland, Ohio 44106, United States
  • GSK Investigational Site
    Erie, Pennsylvania 16505, United States
  • GSK Investigational Site
    Hermitage, Pennsylvania 16148, United States
  • GSK Investigational Site
    Sellersville, Pennsylvania 18960, United States
  • GSK Investigational Site
    Warwick, Rhode Island 02886, United States
  • GSK Investigational Site
    Barnwell, South Carolina 29812, United States
  • GSK Investigational Site
    Kingsport, Tennessee 37660, United States
  • GSK Investigational Site
    Fort Worth, Texas 76107, United States
  • GSK Investigational Site
    Houston, Texas 77070, United States
  • GSK Investigational Site
    League City, Texas 77573, United States
  • GSK Investigational Site
    San Antonio, Texas 78229, United States
  • GSK Investigational Site
    Tomball, Texas 77375, United States
  • GSK Investigational Site
    Layton, Utah 84041, United States
  • GSK Investigational Site
    Payson, Utah 84651, United States
  • GSK Investigational Site
    Provo, Utah 84604, United States
  • GSK Investigational Site
    Roy, Utah 84067, United States
  • GSK Investigational Site
    Saint George, Utah 84790, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84109, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84121, United States
  • GSK Investigational Site
    Syracuse, Utah 84075, United States
  • GSK Investigational Site
    West Jordan, Utah 84088, United States
  • GSK Investigational Site
    Charlottesville, Virginia 22902, United States
  • GSK Investigational Site
    Falls Church, Virginia 22042, United States
  • GSK Investigational Site
    Richmond, Virginia 23298, United States
  • GSK Investigational Site
    Seattle, Washington 98104, United States
  • GSK Investigational Site
    Madison, Wisconsin 53792, United States
  • GSK Investigational Site
    Marshfield, Wisconsin 54449, United States
  • GSK Investigational Site
    Tallinn, 10117, Estonia
  • GSK Investigational Site
    Tallinn, 10617, Estonia
  • GSK Investigational Site
    Tallinn, 13419, Estonia
  • GSK Investigational Site
    Tallinn, 13619, Estonia
  • GSK Investigational Site
    Tartu, 50106, Estonia
  • GSK Investigational Site
    Espoo, 02230, Finland
  • GSK Investigational Site
    Helsinki, 00100, Finland
  • GSK Investigational Site
    Helsinki, 00930, Finland
  • GSK Investigational Site
    Jarvenpaa, 04400, Finland
  • GSK Investigational Site
    Kokkola, 67100, Finland
  • GSK Investigational Site
    Oulu, 90220, Finland
  • GSK Investigational Site
    Pori, 28100, Finland
  • GSK Investigational Site
    Seinajoki, 60100, Finland
  • GSK Investigational Site
    Tampere, 33100, Finland
  • GSK Investigational Site
    Turku, 20520, Finland
  • GSK Investigational Site
    Durango, 34000, Mexico
  • GSK Investigational Site
    Mexico, 04530, Mexico
  • GSK Investigational Site
    San Juan, 00936-5067, Puerto Rico
  • GSK Investigational Site
    Castellón, 12004, Spain
  • GSK Investigational Site
    Castellón, 12530, Spain
  • GSK Investigational Site
    L'Eliana, Valencia, 46183, Spain
  • GSK Investigational Site
    Quart De Poblet, Valencia, 46930, Spain
  • GSK Investigational Site
    Valencia, 46011, Spain
  • GSK Investigational Site
    Valencia, 46017, Spain
  • GSK Investigational Site
    Valencia, 46020, Spain
  • GSK Investigational Site
    Valencia, 46022, Spain
  • GSK Investigational Site
    Valencia, 46023, Spain
  • GSK Investigational Site
    Valencia, 46200, Spain
09

References and documents

Publications

  • Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco JC, Weiner L, Marshall GS, Silas PE, Sarpong KO, Ramsey KP, Fling JA, Speicher D, Campos M, Munjal I, Peltier C, Vesikari T, Baccarini C, Caplanusi A, Gillard P, Carryn S, Henry O. Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):194-201. doi: 10.1093/jpids/piz010. PubMed 30849175 ↗

Individual participant data

Plan to share: Yes — IPD is available via the Clinical Study Data Request site (click on the link provided below)

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · clinicalstudydatarequest.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2012 to primary completion in Nov 2014, 24 months.

Results were first posted in Jun 2018, 3 years 7 months after primary completion. A results delay was requested in Nov 2015.

Of 15 phase 3 interventional studies under Rubella, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 15. This study's 24 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2012
First posted
Oct 8, 2012
StartActual
Nov 9, 2012
Primary completionActual
Nov 25, 2014
CompletionActual
Apr 16, 2015
Results delay requested
Nov 23, 2015
Results first posted
Jun 28, 2018
Last update
Nov 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01702428
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 8, 2012
Start date
Nov 9, 2012
Primary completion
Nov 25, 2014
Completion
Apr 16, 2015
Results posted
Jun 28, 2018
Last update
Nov 25, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

Questions 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.

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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: Measles-Mumps-Rubella Vaccine

Other studies in this condition

Rubella →

Other studies from this sponsor

GlaxoSmithKline →

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