A Phase 2 interventional study of GSK Biological's investigational vaccine 209762 and M-M-R® II (Merck and Co) in Rubella, Mumps and Measles, sponsored by GlaxoSmithKline. Completed at 48 sites in 2 countries. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-03.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
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.
85 studies on the registry are indexed under Rubella; 11 are open to participants now.
This study's enrollment of 1,259 is above the median of 801 across 71 interventional studies indexed under Rubella.
Browse Rubella studies →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.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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 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.
Biological: M-M-R® II (Merck and Co) · Biological: Varivax® · Biological: Havrix® · Biological: Prevnar®
Subcutaneous injection, one dose
Drug page: Measles-Mumps-Rubella Vaccine
Subcutaneous injection, one dose
Subcutaneous injection, one dose
Intramuscular injection, one dose
Intramuscular injection, one dose
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.
Time frame: 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.
Time frame: 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).
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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
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)
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Solicited local symptoms assessed were pain, redness and swelling.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
Antibody titers were expressed as Geometric Mean Titer (GMT).
Time frame: 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).
Time frame: At 1 year post-vaccination
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Antibody concentrations are expressed as Geometric Mean Titer (GMT).
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: At 2 years post-vaccination
The study was divided in 3 phases: the active phase (up to Day 42), the extended safety follow-up (ESFU) phase (up to Day 180) and the antibody persistence phase (up to Day 730).
| Milestone | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Started | 304 | 304 | 304 | 308 |
| Completed | 287 | 275 | 280 | 275 |
| Not completed | 17 | 29 | 24 | 33 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 7 | 19 | 17 | 12 |
| Withdrew: Withdrawal by subject | 10 | 6 | 6 | 19 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 0 |
| Withdrew: Migration from study area | 0 | 3 | 1 | 0 |
| Withdrew: Blood draws | 0 | 0 | 0 | 1 |
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.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. | 245 | 236 | 236 | 248 |
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.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value. | 175 | 183 | 175 | 175 |
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 244 | 235 | 233 | 249 |
Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value. | 240 | 230 | 230 | 241 |
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.
| mIU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-measles Virus Antibody Concentrations | 2798.7 (2544.8 to 3077.9) | 2878.2 (2607.0 to 3177.7) | 2593.1 (2350.3 to 2861.1) | 2949.5 (2698.4 to 3224.0) |
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.
| Titers | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-mumps Virus Antibody Concentrations | 242.0 (204.5 to 286.5) | 265.0 (221.8 to 316.5) | 253.4 (213.4 to 300.9) | 267.6 (224.2 to 319.5) |
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.
| IU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-rubella Virus Antibody Concentrations | 72.2 (65.6 to 79.6) | 77.7 (70.4 to 85.7) | 68.2 (61.8 to 75.3) | 89.4 (81.4 to 98.2) |
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
| µg/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-S.PNEU-4 | 3.57 (3.04 to 4.20) | 3.72 (3.21 to 4.31) | 3.40 (2.88 to 4.00) | 3.80 (3.17 to 4.56) |
| Anti-S. PNEU-6B | 5.68 (4.78 to 6.76) | 5.87 (5.02 to 6.87) | 5.41 (4.66 to 6.28) | 7.22 (6.28 to 8.29) |
| Anti-S.PNEU 9V | 6.56 (5.66 to 7.60) | 7.30 (6.35 to 8.38) | 5.81 (4.97 to 6.78) | 7.80 (6.81 to 8.93) |
| Anti-S.PNEU-14 | 9.23 (8.03 to 10.61) | 8.33 (7.30 to 9.51) | 7.58 (6.55 to 8.76) | 7.97 (6.95 to 9.14) |
| Anti-S.PNEU-18 C | 6.20 (5.30 to 7.26) | 6.62 (5.76 to 7.60) | 6.15 (5.25 to 7.21) | 6.73 (5.74 to 7.91) |
| Anti-S.PNEU-19 F | 2.42 (2.05 to 2.85) | 2.46 (2.11 to 2.88) | 2.34 (2.00 to 2.73) | 2.59 (2.23 to 3.00) |
| Anti-S.PNEU-23 F | 9.34 (7.76 to 11.25) | 9.27 (7.82 to 10.99) | 8.33 (6.88 to 10.10) | 11.49 (9.67 to 13.66) |
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.
| mIU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-varicella Antibody Concentrations. | 245.5 (229.0 to 263.3) | 235.2 (217.4 to 254.4) | 236.0 (218.0 to 255.5) | 255.9 (240.4 to 272.4) |
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.
| mIU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-hepatitis A Virus Antibody Concentrations. | 33.8 (28.8 to 39.6) | 39.2 (33.1 to 46.5) | 39.4 (32.7 to 47.5) | 42.1 (35.8 to 49.6) |
Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value. | 98 | 99 | 94 | 110 |
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
| µg/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-S.PNEU-4 | 0.54 (0.46 to 0.65) | 0.61 (0.52 to 0.72) | 0.67 (0.58 to 0.78) | 0.67 (0.56 to 0.81) |
| Anti-S.PNEU-6B | 0.53 (0.43 to 0.66) | 0.57 (0.46 to 0.70) | 0.52 (0.43 to 0.64) | 0.67 (0.56 to 0.80) |
| Anti-S.PNEU-9V | 1.01 (0.85 to 1.20) | 1.13 (0.97 to 1.32) | 1.04 (0.88 to 1.23) | 1.26 (1.06 to 1.49) |
| Anti-S.PNEU-14 | 3.01 (2.60 to 3.47) | 2.82 (2.42 to 3.28) | 2.54 (2.21 to 2.92) | 2.76 (2.38 to 3.20) |
| Anti-S.PNEU-18C | 0.88 (0.74 to 1.03) | 0.97 (0.83 to 1.13) | 0.97 (0.83 to 1.14) | 1.00 (0.86 to 1.15) |
| Anti-S.PNEU-19F | 0.40 (0.32 to 0.50) | 0.40 (0.33 to 0.50) | 0.44 (0.36 to 0.53) | 0.45 (0.37 to 0.56) |
| Anti-S.PNEU-23 F | 0.64 (0.51 to 0.82) | 0.63 (0.51 to 0.77) | 0.65 (0.52 to 0.81) | 0.85 (0.67 to 1.08) |
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 211 | 211 | 218 | 209 |
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 171 | 159 | 168 | 166 |
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.
| mIU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-measles Virus Antibody Concentrations | 3361.1 (2922.3 to 3865.6) | 3963.8 (3479.3 to 4515.7) | 3360.3 (2923.3 to 3862.7) | 4022.1 (3507.7 to 4611.9) |
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.
| mIU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-measles Virus Antibody Concentrations | 3224.3 (2840.1 to 3660.5) | 3708.2 (3226.2 to 4262.2) | 3534.7 (3139.9 to 3979.1) | 3828.1 (3371.3 to 4346.7) |
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Varicella like | 0 | 4 | 0 | 0 |
| Measles/Rubella like | 6 | 7 | 5 | 5 |
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.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects Reporting Febrile Convulsions | 0 | 1 | 0 | 1 |
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.
| Titers | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN)) | 162.8 (141.8 to 186.9) | 188.3 (162.4 to 218.3) | 176.2 (152.6 to 203.3) | 185.5 (163.5 to 210.6) |
Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Localized or generalized | 72 | 74 | 60 | 60 |
| With fever | 26 | 29 | 23 | 23 |
| Grade 3 | 11 | 10 | 6 | 6 |
| Related | 9 | 14 | 6 | 6 |
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN) | 169 | 170 | 171 | 170 |
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.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 212 | 213 | 217 | 210 |
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 171 | 158 | 168 | 166 |
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.
| IU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-rubella Virus Antibody Concentrations | 138.1 (125.3 to 152.2) | 145.4 (132.0 to 160.1) | 136.5 (123.5 to 150.9) | 166.8 (151.5 to 183.6) |
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.
| IU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-rubella Virus Antibody Concentrations | 78.0 (69.7 to 87.2) | 79.5 (71.7 to 88.2) | 81.7 (73.8 to 90.4) | 93.1 (83.6 to 103.6) |
fever is assessed for temperature ≥38°C/100.4°F and \>39.5°C/103.1°F as measured rectally.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Day 15 (N= 283; 275; 283; 277) ≥38.0°C | 65 | 79 | 64 | 56 |
| Day 15 (N= 283; 275; 283; 277) >39.5°C | 10 | 7 | 9 | 8 |
| Day 43 (N= 283; 275; 283; 277) ≥38.0°C | 103 | 104 | 104 | 85 |
| Day 43 (N= 283; 275; 283; 277) >39.5°C | 20 | 14 | 18 | 13 |
Solicited local symptoms assessed were pain, redness and swelling.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Pain | 70 | 70 | 79 | 67 |
| Redness | 45 | 47 | 41 | 47 |
| Swelling | 20 | 26 | 19 | 15 |
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.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects Reporting Medically Attended Visit (MAEs) | 99 | 99 | 97 | 107 |
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.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs). | 170 | 153 | 164 | 169 |
Swelling with accompanying general symptoms
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling. | 3 | 3 | 5 | 2 |
Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Any drowsiness | 133 | 106 | 113 | 109 |
| Any irritability | 180 | 141 | 150 | 153 |
| Any loss of appetite | 111 | 77 | 110 | 94 |
NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs). | 5 | 2 | 4 | 2 |
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.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 | 6 | 7 | 9 |
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.
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs). | 0 | 0 | 0 | 1 |
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. | 27 | 28 | 22 | 26 |
Antibody titers were expressed as Geometric Mean Titer (GMT).
| Titer | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 31.0 (24.1 to 39.9) | 46.1 (36.2 to 58.7) | 39.3 (31.0 to 50.0) | 46.6 (36.6 to 59.3) |
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 173 | 186 | 184 | 173 |
Antibody concentrations are expressed as Geometric Mean Titer (GMT).
| Titer | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 43.4 (33.4 to 56.3) | 48.9 (37.7 to 63.5) | 57.4 (45.7 to 72.2) | 60.7 (47.6 to 77.5) |
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 144 | 134 | 152 | 144 |
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.
| EU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA) | 47.3 (39.2 to 57.1) | 42.9 (36.4 to 50.6) | 42.5 (35.9 to 50.3) | 58.6 (50.6 to 67.8) |
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 155 | 159 | 162 | 164 |
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.
| EU/mL | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Anti-mumps Virus Antibody Concentrations (PPD ELISA) | 47.8 (40.2 to 56.9) | 50.2 (42.1 to 59.9) | 54.0 (46.1 to 63.3) | 59.2 (50.1 to 70.0) |
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
| Subjects | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 128 | 125 | 136 | 134 |
Collected over Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Priorix 1 Group | 0/304 (0%) | 1/304 (0.3%) | 240/304 (78.9%) |
| Priorix 2 Group | 0/304 (0%) | 7/304 (2.3%) | 216/304 (71.1%) |
| Priorix 3 Group | 0/304 (0%) | 8/304 (2.6%) | 219/304 (72%) |
| MMR-II Group | 0/308 (0%) | 10/308 (3.2%) | 221/308 (71.8%) |
| Event | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| BronchiolitisInfections and infestations | 1/304 | 1/304 | 0/304 | 2/308 |
| HypoxiaGeneral disorders | 0/304 | 0/304 | 0/304 | 2/308 |
| BronchiolitisInfections and infestations | 1/304 | 1/304 | 0/304 | 2/308 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/304 | 0/304 | 0/304 | 2/308 |
| BronchitisInfections and infestations | 0/304 | 0/304 | 1/304 | 1/308 |
| PneumoniaInfections and infestations | 0/304 | 0/304 | 1/304 | 1/308 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/304 | 1/304 | 0/304 | 0/308 |
| CellulitisInfections and infestations | 0/304 | 0/304 | 1/304 | 0/308 |
| Coxsackie viral infectionInfections and infestations | 0/304 | 0/304 | 1/304 | 0/308 |
| Extremity necrosisVascular disorders | 0/304 | 1/304 | 0/304 | 0/308 |
| Event | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group |
|---|---|---|---|---|
| IrritabilityPsychiatric disorders | 181/304 | 142/304 | 150/304 | 153/308 |
| SomnolenceNervous system disorders | 133/304 | 106/304 | 113/304 | 109/308 |
| Decreased appetiteMetabolism and nutrition disorders | 111/304 | 77/304 | 110/304 | 95/308 |
| PainGeneral disorders | 72/304 | 70/304 | 79/304 | 68/308 |
| ErythemaSkin and subcutaneous tissue disorders | 46/304 | 48/304 | 43/304 | 49/308 |
| Upper respiratory tract infectionInfections and infestations | 40/304 | 22/304 | 39/304 | 43/308 |
| TeethingGastrointestinal disorders | 35/304 | 35/304 | 37/304 | 35/308 |
| Otitis mediaInfections and infestations | 25/304 | 25/304 | 29/304 | 24/308 |
| SwellingGeneral disorders | 22/304 | 26/304 | 20/304 | 15/308 |
| CoughRespiratory, thoracic and mediastinal disorders | 25/304 | 21/304 | 16/304 | 19/308 |
| Age, Continuous(Months) | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group | Total |
|---|---|---|---|---|---|
| Mean | 12.4 ± 0.75 | 12.4 ± 0.73 | 12.2 ± 0.56 | 12.4 ± 0.75 | 12.4 ± 0.70 |
| Sex: Female, Male(Participants) | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group | Total |
|---|---|---|---|---|---|
| Female | 156 | 144 | 157 | 139 | 596 |
| Male | 148 | 160 | 147 | 169 | 624 |
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
Ran from Jun 2009 to primary completion in Jul 2010, 13 months.
Results were first posted in Nov 2011, 1 year 3 months after primary completion.
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