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CompletedNCT01621802Updated Nov 25, 2019Results posted

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

A Phase 3 interventional study of Priorix and M-M-R II in Measles-Mumps-Rubella, sponsored by GlaxoSmithKline. Completed at 67 sites in 3 countries. Open to participants aged 4 Years to 6 Years, 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
4,011
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study summary

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

Read the detailed description

The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.

The Inv_MMR vaccine will be administered as a second dose to children who already received a first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.

02

Conditions studied

  • Measles-Mumps-Rubella

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Keywords

  • Safety
  • Measles, mumps and rubella diseases
  • Immunogenicity
03

In context

Measles

134 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 4,011 is above the median of 852 across 105 interventional studies indexed under Measles.

Browse Measles 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
4 Years to 6 Years
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

  • Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.
  • Male or female subjects 4 to 6 years of age at the time of vaccination.
  • Written is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
  • Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
  • Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.

  • For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:

    • subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
    • subjects received a first dose of VV in the second year of life.

Exclusion criteria

Exclusion Criteria:

  • Child in care.
  • Use of any or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.
  • Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
  • Chronic administration of or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical are allowed.
  • Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of measles, mumps, and/or rubella disease.
  • Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic to neomycin 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. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C (100.4°F) measured by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
  • Active untreated tuberculosis according to the subject's medical history.
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:

  • Previous vaccination with a second dose of varicella-containing vaccine.
  • Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination.
  • History of varicella/zoster disease.
  • Known exposure to varicella/zoster during the period starting 30 days prior to enrollment.
  • History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
  • Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids.
  • Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine.
  • Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
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
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4,011 participants (actual)

Study arms

  • Experimental
    Inv _MMR_CO Group

    Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).

    Biological: Priorix · Biological: Kinrix · Biological: ProQuad

  • Active comparator
    Com_MMR_CO Group

    Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).

    Biological: M-M-R II · Biological: Kinrix · Biological: ProQuad

  • Experimental
    Inv_MMR_I Group

    Subjects received one dose of Priorix at Visit 1 (Day 0).

    Biological: Priorix

  • Active comparator
    Com_MMR_I Group

    Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).

    Biological: M-M-R II

  • Experimental
    Inv _MMR_S Group

    Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).

    Biological: Priorix

  • Active comparator
    Com_MMR_S Group

    Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).

    Biological: M-M-R II

Interventions

  • BiologicalPriorix

    One dose administered subcutaneously in the triceps region of the right arm.

  • BiologicalM-M-R II

    One dose administered subcutaneously in the triceps region of the right arm.

  • BiologicalKinrix

    One dose administered by deep intramuscular injection in the upper left deltoid.

  • BiologicalProQuad

    One dose administered subcutaneously in the triceps region of the left arm.

06

What researchers measure

Primary outcomes

  1. Number 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 equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.

    Time frame: 42 days post vaccination (At Day 42)

  2. Number 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 Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.

    Time frame: 42 days post vaccination (At Day 42)

  3. Number 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 Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.

    Time frame: 42 days post vaccination (At Day 42)

  4. Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations

    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.

    Time frame: 42 days after vaccination (At Day 42)

  5. Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations

    Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.

    Time frame: 42 days post vaccination (At Day 42)

  6. Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations

    Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.

    Time frame: 42 days post vaccination (At Day 42)

Secondary outcomes

  1. Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value

    Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  2. Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations

    Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  3. Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)

    Booster response was defined as: For subjects with pre-vaccination antibody concentration less than (\<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42. For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  4. Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)

    Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  5. Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)

    Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  6. Number of Subjects With Antibody Booster Response to Pertactin (PRN)

    Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  7. Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations

    Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  8. Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  9. Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL

    Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  10. Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL

    Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  11. Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers

    Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.

    Time frame: 42 days post vaccination (At Day 42)

  12. Number of Subjects With Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . \> 50mm.

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

  13. Number of Subjects With Solicited General Symptoms

    Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination. Analysis was done for sub-cohort 1 only.

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

  14. Number of Subjects Reporting Fever

    Any fever = fever ≥ 38°C; Grade 3 fever = fever \> 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.

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

  15. Number of Subjects Reporting MMR Specific Solicited General Symptoms

    Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.

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

  16. Number of Subjects Reporting Investigator-confirmed Rash

    Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.

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

  17. Number of Subjects With New Onset Chronic Diseases (NOCDs)

    NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

    Time frame: During the entire study period (from Day 0 up to Day 180)

  18. Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

    The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.

    Time frame: During the entire study period (from Day 0 up to Day 180)

  19. Number of Subjects With Unsolicited Adverse Events (AEs)

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

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

  20. Number of Subjects With Serious Adverse Events (SAEs)

    Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.

    Time frame: During the entire study period (from Day 0 up to Day 180)

07

Results

Posted Sep 13, 2017

Participant flow

Subjects were enrolled in 3 sub-cohorts. Sub-cohort 1: Inv_MMR_CO and Com_MMR_CO (Lot 1 or Lot 2), Sub-cohort 2: Inv_MMR_I and Com_MMR_I (Lot 1 or Lot 2) and Sub-cohort 3: Inv_MMR_S and Com_MMR_S (Lot 1 or Lot 2).

Participant flow — Overall Study
MilestoneInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Started8022987963031319489
Completed7552757632921284477
Not completed472333113512
Withdrew: Protocol violation000001
Withdrew: Withdrawal by subject844220
Withdrew: Migrated/moved from study area002010
Withdrew: Others333210
Withdrew: Lost to follow-up36162473111

Outcome measures

PrimaryNumber 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 equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I Group
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value697249736281
Statistical analysis
  • Inv_MMR_CO Group vs Com_MMR_CO Group · Difference in seroresponse rate (%): 0.00 · 97.5% CI -0.72 to 1.98Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.
  • Inv_MMR_I Group vs Com_MMR_I Group · Difference in seroresponse rate (%): 0.71 · 97.5% CI 0.02 to 2.97Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.
PrimaryNumber 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 Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I Group
Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value698250736283
Statistical analysis
  • Inv_MMR_CO Group vs Com_MMR_CO Group · Difference in seroresponse rate (%): 0.00 · 97.5% CI -0.72 to 1.97Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.
  • Inv_MMR_I Group vs Com_MMR_I Group · Difference in seroresponse rate (%): 0.00 · 97.5% CI -0.68 to 1.75Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.
PrimaryNumber 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 Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I Group
Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value696249736283
Statistical analysis
  • Inv_MMR_CO Group vs Com_MMR_CO Group · Difference in seroresponse rate (%): -0.14 · 97.5% CI -0.98 to 1.84Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.
  • Inv_MMR_I Group vs Com_MMR_I Group · Difference in seroresponse rate (%): 0.00 · 97.5% CI -0.68 to 1.75Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.
PrimaryEvaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.

Time frame:
42 days after vaccination (At Day 42)
Reported as:
Geometric mean · mIU/mL
Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations
mIU/mLInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I Group
Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations4335.0 (4089.7 to 4594.9)4215.6 (3806.7 to 4668.4)3646.6 (3453.5 to 3850.4)3503.9 (3174.6 to 3867.4)
Statistical analysis
  • Inv_MMR_CO Group vs Com_MMR_CO Group · ANCOVA · Adjusted gmc ratio: 0.99 · 97.5% CI 0.92 to 1.06The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
  • Inv_MMR_I Group vs Com_MMR_I Group · ANCOVA · Adjusted gmc ratio: 1.03 · 97.5% CI 0.96 to 1.10The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
PrimaryEvaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations

Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Geometric mean · EU/mL
Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations
EU/mLInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I Group
Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations170.5 (161.6 to 179.9)190.1 (174.7 to 206.8)167.2 (158.6 to 176.3)176.2 (161.5 to 192.2)
Statistical analysis
  • Inv_MMR_CO Group vs Com_MMR_CO Group · ANCOVA · Adjusted gmc ratio: 0.91 · 97.5% CI 0.83 to 1.00The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
  • Inv_MMR_I Group vs Com_MMR_I Group · ANCOVA · Adjusted gmc ratio: 0.96 · 97.5% CI 0.87 to 1.06The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
PrimaryEvaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations

Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Geometric mean · IU/mL
Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations
IU/mLInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I Group
Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations96.4 (92.6 to 100.4)96.0 (89.5 to 103.0)98.9 (95.3 to 102.8)98.7 (93.2 to 104.5)
Statistical analysis
  • Inv_MMR_CO Group vs Com_MMR_CO Group · ANCOVA · Adjusted gmc ratio: 1.03 · 97.5% CI 0.97 to 1.09The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
  • Inv_MMR_I Group vs Com_MMR_I Group · ANCOVA · Adjusted gmc ratio: 1.01 · 97.5% CI 0.95 to 1.07The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
SecondaryNumber of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value

Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value
ParticipantsInv_MMR_CO GroupCom_MMR_CO Group
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value693247
SecondaryEvaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations

Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Geometric mean · mIU/mL
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations
mIU/mLInv_MMR_CO GroupCom_MMR_CO Group
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations887.7 (834.3 to 944.4)820.4 (749.3 to 898.3)
SecondaryNumber of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)

Booster response was defined as: For subjects with pre-vaccination antibody concentration less than (\<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42. For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)
ParticipantsInv_MMR_CO GroupCom_MMR_CO Group
Anti-D657233
Anti-T621224
SecondaryNumber of Subjects With Antibody Booster Response to Pertussis Toxin (PT)

Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)
ParticipantsInv_MMR_CO GroupCom_MMR_CO Group
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)643225
SecondaryNumber of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)

Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)
ParticipantsInv_MMR_CO GroupCom_MMR_CO Group
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)620221
SecondaryNumber of Subjects With Antibody Booster Response to Pertactin (PRN)

Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Antibody Booster Response to Pertactin (PRN)
ParticipantsInv_MMR_CO GroupCom_MMR_CO Group
Number of Subjects With Antibody Booster Response to Pertactin (PRN)657233
SecondaryEvaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations

Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Geometric mean · IU/mL
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations
IU/mLInv_MMR_CO GroupCom_MMR_CO Group
Anti-D17.2 (16.2 to 18.1)17.8 (16.1 to 19.6)
Anti-T7.4 (6.9 to 7.8)8.4 (7.6 to 9.3)
SecondaryEvaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Geometric mean · EU/mL
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
EU/mLInv_MMR_CO GroupCom_MMR_CO Group
Anti-PT76.6 (71.6 to 82.0)73.9 (66.2 to 82.4)
Anti-FHA316.2 (299.4 to 334.0)319.3 (293.1 to 347.9)
Anti-PRN402.2 (370.4 to 436.8)427.3 (377.6 to 483.4)
SecondaryNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL

Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
ParticipantsInv_MMR_CO GroupCom_MMR_CO Group
Anti-D684243
Anti-T684243
SecondaryNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL

Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Count of participants · Participants
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL
ParticipantsInv_MMR_CO GroupCom_MMR_CO Group
Anti-D683242
Anti-T678243
SecondaryEvaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers

Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.

Time frame:
42 days post vaccination (At Day 42)
Reported as:
Geometric mean · ED50
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers
ED50Inv_MMR_CO GroupCom_MMR_CO Group
Anti-Polio 11618.7 (1499.8 to 1747.0)1587.3 (1387.3 to 1816.1)
Anti-Polio 22026.4 (1881.2 to 2182.7)2206.1 (1955.2 to 2489.3)
Anti-Polio 32753.5 (2512.4 to 3017.6)3040.6 (2613.0 to 3538.1)
SecondaryNumber of Subjects With Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . \> 50mm.

Time frame:
During the 4-day (Days 0-3) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Solicited Local Symptoms
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Any Pain29510915264278123
Grade 3 Pain2246252
Any Redness157691465324290
Grade 3 Redness940000
Any Swelling8228642310842
Grade 3 Swelling330000
SecondaryNumber of Subjects With Solicited General Symptoms

Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination. Analysis was done for sub-cohort 1 only.

Time frame:
During the 4-day (Days 0-3) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Solicited General Symptoms
ParticipantsInv_MMR_CO GroupCom_MMR_CO Group
Any Drowsiness19972
Grade 3 Drowsiness103
Related Drowsiness18063
Any Loss of appetite15459
Grade 3 Loss of appetite22
Related Loss of appetite13556
SecondaryNumber of Subjects Reporting Fever

Any fever = fever ≥ 38°C; Grade 3 fever = fever \> 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.

Time frame:
During the 43-day (Days 0-42) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Reporting Fever
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Any fever177671465825796
Grade 3 fever76149218
Related fever1003227115225
SecondaryNumber of Subjects Reporting MMR Specific Solicited General Symptoms

Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.

Time frame:
During the 43-day (Days 0-42) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Reporting MMR Specific Solicited General Symptoms
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Any Sign of meningism021000
Grade 3 Sign of meningism000000
Related Sign of meningism020000
Any Parotid gland swelling000111
Grade 3 Parotid gland swelling000000
Related Parotid gland swelling000111
SecondaryNumber of Subjects Reporting Investigator-confirmed Rash

Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.

Time frame:
During the 43-day (Days 0-42) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects Reporting Investigator-confirmed Rash
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Any localized or generalized612837125623
Any with fever1175161
Any Varicella like430000
Any Measles/Rubella like1453242
Any grade 3301030
Any related25112283
Localized any50242794219
Localized administration site921080
Localized other site41222693619
Localized with fever864041
Localized Varicella like220000
Localized Measles/Rubella like1243241
Localized Grade 3201000
Localized related18102272
Generalized any124103154
Generalized with fever311120
Generalized Varicella like210000
Generalized Measles/Rubella like210001
Generalized Grade 3100030
Generalized Related710011
SecondaryNumber of Subjects With New Onset Chronic Diseases (NOCDs)

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Time frame:
During the entire study period (from Day 0 up to Day 180)
Reported as:
Count of participants · Participants
Number of Subjects With New Onset Chronic Diseases (NOCDs)
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Number of Subjects With New Onset Chronic Diseases (NOCDs)8460113
SecondaryNumber of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.

Time frame:
During the entire study period (from Day 0 up to Day 180)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits6129642210236
SecondaryNumber of Subjects With Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame:
During the 43-day (Days 0-42) post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Unsolicited Adverse Events (AEs)
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Number of Subjects With Unsolicited Adverse Events (AEs)27690314112508186
SecondaryNumber of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.

Time frame:
During the entire study period (from Day 0 up to Day 180)
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events (SAEs)
ParticipantsInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Number of Subjects With Serious Adverse Events (SAEs)40141259

Adverse events

Collected over Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Inv_MMR_CO Group0/802 (0%)4/802 (0.5%)544/802 (67.8%)
Com_MMR_CO Group0/298 (0%)0/298 (0%)198/298 (66.4%)
Inv_MMR_I Group0/796 (0%)14/796 (1.8%)410/796 (51.5%)
Com_MMR_I Group0/303 (0%)1/303 (0.3%)156/303 (51.5%)
Inv_MMR_S Group0/1,319 (0%)25/1,319 (1.9%)702/1,319 (53.2%)
Com_MMR_S Group0/489 (0%)9/489 (1.8%)279/489 (57.1%)
Most frequent serious events
Showing 10 of 42
Most frequent serious events
EventInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
InfluenzaInfections and infestations0/8020/2980/7960/3031/13193/489
PneumoniaInfections and infestations0/8020/2982/7961/3030/13193/489
AsthmaRespiratory, thoracic and mediastinal disorders2/8020/2984/7960/3030/13192/489
GastroenteritisInfections and infestations0/8020/2982/7960/3035/13191/489
ThrombocytopeniaBlood and lymphatic system disorders0/8020/2980/7960/3030/13191/489
Inguinal herniaGastrointestinal disorders0/8020/2980/7960/3030/13191/489
Adenovirus infectionInfections and infestations0/8020/2980/7960/3030/13191/489
BronchitisInfections and infestations0/8020/2980/7960/3030/13191/489
TonsillitisInfections and infestations0/8020/2980/7960/3032/13191/489
ConcussionInjury, poisoning and procedural complications0/8020/2980/7960/3030/13191/489
Most frequent other events
Most frequent other events
EventInv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S Group
Injection site painGeneral disorders309/802118/298153/79664/303278/1319123/489
SomnolenceNervous system disorders199/80273/2981/7960/3030/13190/489
Injection site erythemaGeneral disorders170/80273/298147/79653/303242/131990/489
PyrexiaGeneral disorders177/80267/298146/79658/303257/131996/489
Decreased appetiteMetabolism and nutrition disorders156/80261/2982/7961/3033/13190/489
Injection site swellingGeneral disorders97/80231/29864/79623/303108/131942/489
NasopharyngitisInfections and infestations25/8023/29877/79628/303112/131945/489
RashSkin and subcutaneous tissue disorders61/80228/29837/79612/30356/131923/489
Upper respiratory tract infectionInfections and infestations27/80211/29855/79627/30392/131921/489
CoughRespiratory, thoracic and mediastinal disorders38/80216/29837/7968/30347/131921/489

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Inv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S GroupTotal
Mean4.1 ± 0.34.1 ± 0.34.4 ± 0.64.3 ± 0.64.4 ± 0.64.4 ± 0.64.3 ± 0.6
Sex: Female, Male
Sex: Female, Male(Participants)Inv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S GroupTotal
Female3981343611536322251903
Male4041644351506872642104
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Inv_MMR_CO GroupCom_MMR_CO GroupInv_MMR_I GroupCom_MMR_I GroupInv_MMR_S GroupCom_MMR_S GroupTotal
Race/Ethnicity — African Heritage / African American963948199432328
Race/Ethnicity — American Indian or Alaskan Native1303815340190
Race/Ethnicity — Asian - Central/South Asian Heritage125718033
Race/Ethnicity — Asian - East Asian Heritage2863841465652091338
Race/Ethnicity — Asian - Japanese Heritage3001105
Race/Ethnicity — Asian - South East Asian Heritage4925114168113
Race/Ethnicity — Native Hawaiian or Other Pacific Islander42203011
Race/Ethnicity — Other112453595222275
Race/Ethnicity — White - Arabic / North African Heritage53331015
Race/Ethnicity — White - Caucasian / European Heritage3631352911175752181699
08

Study locations

67 sites
  • GSK Investigational Site
    Birmingham, Alabama 35205, United States
  • GSK Investigational Site
    Tucson, Arizona 85704, United States
  • GSK Investigational Site
    Tucson, Arizona 85741, United States
  • GSK Investigational Site
    Benton, Arkansas 72019, United States
  • GSK Investigational Site
    Fayetteville, Arkansas 72703, United States
  • GSK Investigational Site
    Little Rock, Arkansas 72205, United States
  • GSK Investigational Site
    Anaheim, California 92804, United States
  • GSK Investigational Site
    Baldwin Park, California 91706, 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
    Oakland, California 94611, 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 80922, United States
  • GSK Investigational Site
    Altamonte Springs, Florida 32701, United States
  • GSK Investigational Site
    Marietta, Georgia 30062, United States
  • GSK Investigational Site
    Woodstock, Georgia 30189, United States
  • GSK Investigational Site
    Nampa, Idaho 83686, United States
  • GSK Investigational Site
    Indianapolis, Indiana 46256, United States
  • GSK Investigational Site
    Augusta, Kansas 67010, United States
  • GSK Investigational Site
    Newton, Kansas 67114, United States
  • GSK Investigational Site
    Bardstown, Kentucky 40004, United States
  • GSK Investigational Site
    Columbia, Maryland 21045, United States
  • GSK Investigational Site
    Fall River, Massachusetts 02721, United States
  • GSK Investigational Site
    Bronx, New York 10467, United States
  • GSK Investigational Site
    Asheboro, North Carolina 27203, United States
  • GSK Investigational Site
    Raleigh, North Carolina 27609, United States
  • GSK Investigational Site
    Cincinnati, Ohio 45245, United States
  • GSK Investigational Site
    Cleveland, Ohio 44121, United States
  • GSK Investigational Site
    Dayton, Ohio 45406, United States
  • GSK Investigational Site
    Dayton, Ohio 45414, United States
  • GSK Investigational Site
    Gresham, Oregon 97030, United States
  • GSK Investigational Site
    Erie, Pennsylvania 16505, United States
  • GSK Investigational Site
    Charleston, South Carolina 29414, United States
  • GSK Investigational Site
    Cheraw, South Carolina 29520, United States
  • GSK Investigational Site
    Rapid City, South Dakota 57701, United States
  • GSK Investigational Site
    Houston, Texas 77055, United States
  • GSK Investigational Site
    Tomball, Texas 77375, United States
  • GSK Investigational Site
    Provo, Utah 84604, United States
  • GSK Investigational Site
    Saint George, Utah 84790, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84109, United States
  • GSK Investigational Site
    South Jordan, Utah 84095, United States
  • GSK Investigational Site
    Burke, Virginia 22015, United States
  • GSK Investigational Site
    Charlottesville, Virginia 22902, United States
  • GSK Investigational Site
    Huntington, West Virginia 25701, United States
  • GSK Investigational Site
    Monroe, Wisconsin 53566, United States
  • GSK Investigational Site
    Ansan, 425-707, Korea, Republic of
  • GSK Investigational Site
    Daegu, 700-712, Korea, Republic of
  • GSK Investigational Site
    Daejeon, 301-723, Korea, Republic of
  • GSK Investigational Site
    Gyeonggi-do, 431-070, Korea, Republic of
  • GSK Investigational Site
    GyeongSangNam-do, 641-560, Korea, Republic of
  • GSK Investigational Site
    Iksan, 570-711, Korea, Republic of
  • GSK Investigational Site
    Jeollabukdo, 561712, Korea, Republic of
  • GSK Investigational Site
    Seoul, 120-752, Korea, Republic of
  • GSK Investigational Site
    Seoul, 130-702, Korea, Republic of
  • GSK Investigational Site
    Seoul, 139-706, Korea, Republic of
  • GSK Investigational Site
    Seoul, 158-710, Korea, Republic of
  • GSK Investigational Site
    Wonju-si Kangwon-do, 220-701, Korea, Republic of
  • GSK Investigational Site
    New Taipei, 220, Taiwan
  • GSK Investigational Site
    Taichung, 404, Taiwan
  • GSK Investigational Site
    Taipei, 100, Taiwan
  • GSK Investigational Site
    Taipei, 104, Taiwan
  • GSK Investigational Site
    Taoyuan, 333, Taiwan
09

References and documents

Publications

  • MMR-158 Study Group. A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration. Hum Vaccin Immunother. 2019;15(4):786-799. doi: 10.1080/21645515.2018.1554971. Epub 2019 Feb 20. PubMed 30785357 ↗

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 Jun 2012 to primary completion in Jul 2015, 36 months.

Results were first posted in Sep 2017, 2 years 2 months after primary completion. A results delay was requested in Jul 2016.

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 36 months is above that.

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

Registered
Jun 14, 2012
First posted
Jun 18, 2012
StartActual
Jun 21, 2012
Primary completionActual
Jul 6, 2015
CompletionActual
Nov 9, 2015
Results delay requested
Jul 6, 2016
Results first posted
Sep 13, 2017
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
NCT01621802
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 18, 2012
Start date
Jun 21, 2012
Primary completion
Jul 6, 2015
Completion
Nov 9, 2015
Results posted
Sep 13, 2017
Last update
Nov 25, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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 drugs tested here: Measles-Mumps-Rubella Vaccine · Measles, mumps, rubella, varicella vaccine

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