RubellaPhase 2NCT00861744
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
A Phase 2 study testing GSK Biological's investigational vaccine 209762, M-M-R® II (Merck and Co) and Varivax® in people with Rubella and Mumps, run by GlaxoSmithKline at 48 sites in 2 countries.
Trial summary
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- What is being tested?
- GSK Biological's investigational vaccine 209762, M-M-R® II (Merck and Co) and Varivax®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,259 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 3 Jun 2009to 18 Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
- Written informed consent obtained from the parent/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- 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 (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
- Previous vaccination against measles, mumps, rubella and/or varicella.
- Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
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- History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Hypersensitivity to latex
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures, including febrile seizures.
- Acute disease at the time of enrolment.
- Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States45 sites
GSK Investigational Site
Altamonte Springs, Florida, 32701
GSK Investigational Site
Anaheim, California, 92804
GSK Investigational Site
Arkansas City, Kansas, 67005
GSK Investigational Site
Baltimore, Maryland, 21021
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Cary, North Carolina, 27518
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cincinnati, Ohio, 45245
GSK Investigational Site
Conway, Arkansas, 72034
GSK Investigational Site
Corpus Christi, Texas, 78411
GSK Investigational Site
Dalton, Georgia, 30721
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
DeKalb, Illinois, 60115
GSK Investigational Site
Downey, California, 90241
GSK Investigational Site
East Norriton, Pennsylvania, 19401
GSK Investigational Site
Fall River, Massachusetts, 02724
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Great Falls, Montana, 59405
GSK Investigational Site
Gresham, Oregon, 97030
GSK Investigational Site
Henderson, Nevada, 89015
GSK Investigational Site
Huntington, West Virginia, 25701
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Rydal, Pennsylvania, 19046
GSK Investigational Site
Santa Ana, California, 92701-4607
GSK Investigational Site
Springville, Utah, 84663
GSK Investigational Site
St. George, Utah, 84790
GSK Investigational Site
Tulsa, Oklahoma, 74127
GSK Investigational Site
Tuscaloosa, Alabama, 35401
GSK Investigational Site
Utica, New York, 13502
GSK Investigational Site
Virginia Beach, Virginia, 23454
GSK Investigational Site
West Covina, California, 91790
GSK Investigational Site
West Jordan, Utah, 84088
Puerto Rico3 sites
GSK Investigational Site
Bayamón, 00959
GSK Investigational Site
San German, 00683
GSK Investigational Site
San Juan, 00936-5067
About this study
Official title: A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.
The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
- Conditions
- Rubella, Mumps, Measles, Measles-Mumps-Rubella Vaccine
- Being tested
- GSK Biological's investigational vaccine 209762, M-M-R® II (Merck and Co), Varivax®, Havrix®, Prevnar®
- Keywords
- Measles, Mumps, Rubella, Varicella Vaccine, Children, Immunogenicity, Safety, Humans, Combined Vaccine, Vaccines
- Medical subject headings
- Rubella, Mumps, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biological's investigational vaccine 209762Biological
Subcutaneous injection, one dose
M-M-R® II (Merck and Co)Biological
Subcutaneous injection, one dose
Varivax®Biological
Subcutaneous injection, one dose
Havrix®Biological
Intramuscular injection, one dose
Prevnar®Biological
Intramuscular injection, one dose
| Study group | Role | What they receive |
|---|---|---|
| Priorix 1 Group | Experimental | Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Receives: Biological: GSK Biological's investigational vaccine 209762; Biological: Varivax®; Biological: Havrix®; Biological: Prevnar® |
| Priorix 2 Group | Experimental | Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Receives: Biological: GSK Biological's investigational vaccine 209762; Biological: Varivax®; Biological: Havrix®; Biological: Prevnar® |
| Priorix 3 Group | Experimental | Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Receives: Biological: GSK Biological's investigational vaccine 209762; Biological: Varivax®; Biological: Havrix®; Biological: Prevnar® |
| MMR-II Group | Active comparator | Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Receives: Biological: M-M-R® II (Merck and Co); Biological: Varivax®; Biological: Havrix®; Biological: Prevnar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Measured: At Day 42 after administration of a dose of Priorix vaccine.
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.
Measured: At Day 42 after administration of a dose of Priorix vaccine.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Measured: At Day 42 after administration of a dose of Priorix vaccine.
Secondary outcomes (40)
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
Measured: At Day 42 after administration of a dose of Varivax vaccine.
Anti-measles Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Measured: At Day 42 after administration of a dose of Priorix vaccine.
Anti-mumps Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
Measured: At Day 42 after administration of a dose of Priorix vaccine.
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Measured: At Day 42 after administration of a dose of Priorix vaccine.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Measured: At Day 42 after vaccination
Anti-varicella Antibody Concentrations.
Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.
Measured: At Day 42 after administration of a dose of Varivax vaccine.
Anti-hepatitis A Virus Antibody Concentrations.
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.
Measured: At Day 42 after administration of a dose of Havrix vaccine.
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
Measured: At Day 42 after administration of a dose of Havrix vaccine.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Measured: At Day 0 before vaccination
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Measured: At 1 year post-vaccination
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Measured: At 2 years post-vaccination
Anti-measles Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Measured: At 2 years post-vaccination
Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Measured: At 1 year post-vaccination
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Febrile Convulsions
Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.
Measured: During the 43-day (Days 0-42) post-vaccination period
Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))
Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
Measured: At 1 year post-vaccination
Number of Subjects Reporting Other Rash.
Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
Measured: At 1 year post-vaccination
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Measured: At 1 year post-vaccination
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Measured: At 2 years post-vaccination
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Measured: At 1 year post-vaccination
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Measured: At 2 years post-vaccination
Number of Subjects Reporting Fever.
fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.
Measured: During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period
Number of Subjects With Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Medically Attended Visit (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
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 = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.
Swelling with accompanying general symptoms
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 15-day (Days 0-14) post-vaccination period
Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).
NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From Day 0 to Day 180 after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Day 0 to Day 180 after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Day 180 to Day 730 after vaccination
Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.
Measured: From Day 0 to Day 180 after vaccination
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Antibody titers were expressed as Geometric Mean Titer (GMT).
Measured: At 1 year post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Measured: At 1 year post-vaccination
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Antibody concentrations are expressed as Geometric Mean Titer (GMT).
Measured: At 2 years post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Measured: At 2 years post-vaccination
Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)
Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
Measured: At 1 year post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Measured: At 1 year post-vaccination
Anti-mumps Virus Antibody Concentrations (PPD ELISA)
Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
Measured: At 2 years post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Measured: At 2 years post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study start3 Jun 2009
- Primary completion21 Jul 2010
- Study completion18 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RubellaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,259 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861744
- Sponsor's protocol ID
- 111870
- Other IDs
- 2011-005860-31
- Status last verified
- Dec 2019
- First submitted
- 12 Mar 2009
- Last updated
- 3 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Mufson MA, Diaz C, Leonardi M, Harrison CJ, Grogg S, Carbayo A, Carlo-Torres S, JeanFreau R, Quintero-Del-Rio A, Bautista G, Povey M, Da Costa C, Nicholson O, Innis BL. Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months. J Pediatric Infect Dis Soc. 2015 Dec;4(4):339-48. doi: 10.1093/jpids/piu081. Epub 2014 Aug 7.
PubMed 26582873Berry AA, Abu-Elyazeed R, Diaz-Perez C, Mufson MA, Harrison CJ, Leonardi M, Twiggs JD, Peltier C, Grogg S, Carbayo A, Shapiro S, Povey M, Baccarini C, Innis BL, Henry O. Two-year antibody persistence in children vaccinated at 12-15 months with a measles-mumps-rubella virus vaccine without human serum albumin. Hum Vaccin Immunother. 2017 Jul 3;13(7):1516-1522. doi: 10.1080/21645515.2017.1309486. Epub 2017 May 8.
PubMed 28481690
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.
- ClinicalTrials.gov ID
- NCT00861744
- Acronym / sponsor ID
- 111870
- Conditions
- Rubella, Mumps, Measles, Measles-Mumps-Rubella Vaccine
- Keywords
- Measles, Mumps, Rubella, Varicella Vaccine, Children, Immunogenicity, Safety, Humans, Combined Vaccine, Vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,259 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2009 (actual)
- Primary completion
- 21 Jul 2010 (actual)
- Study completion
- 18 Jun 2012 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Posted 4 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.
The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Priorix 1 Group | Experimental | Biological: GSK Biological's investigational vaccine 209762, Biological: Varivax®, Biological: Havrix®, Biological: Prevnar®Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. |
| Priorix 2 Group | Experimental | Biological: GSK Biological's investigational vaccine 209762, Biological: Varivax®, Biological: Havrix®, Biological: Prevnar®Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. |
| Priorix 3 Group | Experimental | Biological: GSK Biological's investigational vaccine 209762, Biological: Varivax®, Biological: Havrix®, Biological: Prevnar®Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. |
| MMR-II Group | Active comparator | Biological: M-M-R® II (Merck and Co), Biological: Varivax®, Biological: Havrix®, Biological: Prevnar®Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
- Written informed consent obtained from the parent/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.
Key exclusion criteria (16 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- 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 (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
- Previous vaccination against measles, mumps, rubella and/or varicella.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK Biological's investigational vaccine 209762Subcutaneous injection, one dose | Biological | Priorix 1 Group, Priorix 2 Group, Priorix 3 Group |
| M-M-R® II (Merck and Co)Subcutaneous injection, one dose | Biological | MMR-II Group |
| Varivax®Subcutaneous injection, one dose | Biological | MMR-II Group, Priorix 1 Group, Priorix 2 Group, Priorix 3 Group |
| Havrix®Intramuscular injection, one dose | Biological | MMR-II Group, Priorix 1 Group, Priorix 2 Group, Priorix 3 Group |
| Prevnar®Intramuscular injection, one dose | Biological | MMR-II Group, Priorix 1 Group, Priorix 2 Group, Priorix 3 Group |
Primary outcome
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
40 secondary outcomes
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
Time frame: At Day 42 after administration of a dose of Varivax vaccine.
Anti-measles Virus Antibody Concentrations
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Anti-mumps Virus Antibody Concentrations
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Anti-rubella Virus Antibody Concentrations
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Time frame: At Day 42 after vaccination
Anti-varicella Antibody Concentrations.
Time frame: At Day 42 after administration of a dose of Varivax vaccine.
Anti-hepatitis A Virus Antibody Concentrations.
Time frame: At Day 42 after administration of a dose of Havrix vaccine.
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.
Time frame: At Day 42 after administration of a dose of Havrix vaccine.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Time frame: At Day 0 before vaccination
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Time frame: At 1 year post-vaccination
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Time frame: At 2 years post-vaccination
Anti-measles Virus Antibody Concentrations
Time frame: At 2 years post-vaccination
Anti-measles Virus Antibody Concentrations
Time frame: At 1 year post-vaccination
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Febrile Convulsions
Time frame: During the 43-day (Days 0-42) post-vaccination period
Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))
Time frame: At 1 year post-vaccination
Number of Subjects Reporting Other Rash.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)
Time frame: At 1 year post-vaccination
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Time frame: At 1 year post-vaccination
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Time frame: At 2 years post-vaccination
Anti-rubella Virus Antibody Concentrations
Time frame: At 1 year post-vaccination
Anti-rubella Virus Antibody Concentrations
Time frame: At 2 years post-vaccination
Number of Subjects Reporting Fever.
Time frame: During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Medically Attended Visit (MAEs)
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Unsolicited Adverse Events (AEs).
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Solicited General Symptoms.
Time frame: During the 15-day (Days 0-14) post-vaccination period
Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).
Time frame: From Day 0 to Day 180 after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: From Day 0 to Day 180 after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs).
Time frame: From Day 180 to Day 730 after vaccination
Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.
Time frame: From Day 0 to Day 180 after vaccination
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Time frame: At 1 year post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Time frame: At 1 year post-vaccination
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Time frame: At 2 years post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Time frame: At 2 years post-vaccination
Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)
Time frame: At 1 year post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Time frame: At 1 year post-vaccination
Anti-mumps Virus Antibody Concentrations (PPD ELISA)
Time frame: At 2 years post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Time frame: At 2 years post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26582873Mufson MA, Diaz C, Leonardi M, Harrison CJ, Grogg S, Carbayo A, Carlo-Torres S, JeanFreau R, Quintero-Del-Rio A, Bautista G, Povey M, Da Costa C, Nicholson O, Innis BL. Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months. J Pediatric Infect Dis Soc. 2015 Dec;4(4):339-48. doi: 10.1093/jpids/piu081. Epub 2014 Aug 7.
- Derived from this study: PubMed 28481690Berry AA, Abu-Elyazeed R, Diaz-Perez C, Mufson MA, Harrison CJ, Leonardi M, Twiggs JD, Peltier C, Grogg S, Carbayo A, Shapiro S, Povey M, Baccarini C, Innis BL, Henry O. Two-year antibody persistence in children vaccinated at 12-15 months with a measles-mumps-rubella virus vaccine without human serum albumin. Hum Vaccin Immunother. 2017 Jul 3;13(7):1516-1522. doi: 10.1080/21645515.2017.1309486. Epub 2017 May 8.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK Biological's investigational vaccine 209762, M-M-R® II (Merck and Co) and Varivax® in people with Rubella and Mumps, run by GlaxoSmithKline at 48 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. (time frame: At Day 42 after administration of a dose of Priorix vaccine.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861744, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.