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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005860-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biological's investigational vaccine 209762 | Biological | Subcutaneous injection, one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | At Day 42 after administration of a dose of Priorix vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Day 42 after administration of a dose of Varivax vaccine. |
| Anti-measles Virus Antibody Concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tuscaloosa | Alabama | 35401 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26582873 | Background | 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. | |
| 28481690 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111870 | Clinical Study Report | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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.
The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Priorix 1 Group | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. |
|
| 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 |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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). | 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. | 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. | At 1 year post-vaccination |
| Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | 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. | 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. | 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 | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | From Day 180 to Day 730 after vaccination |
| Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. | From Day 0 to Day 180 after vaccination |
| Anti-mumps Virus Antibody Titers (Unenhanced PRN) | Antibody titers were expressed as Geometric Mean Titer (GMT). | 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). | At 1 year post-vaccination |
| Anti-mumps Virus Antibody Titers (Unenhanced PRN) | Antibody concentrations are expressed as Geometric Mean Titer (GMT). | 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). | 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. | 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) | 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. | 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) | At 2 years post-vaccination |
| Conway |
| Arkansas |
| 72034 |
| United States |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Anaheim | California | 92804 | United States |
| GSK Investigational Site | Downey | California | 90241 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | Santa Ana | California | 92701-4607 | United States |
| GSK Investigational Site | West Covina | California | 91790 | United States |
| GSK Investigational Site | Altamonte Springs | Florida | 32701 | United States |
| GSK Investigational Site | Dalton | Georgia | 30721 | United States |
| GSK Investigational Site | Marietta | Georgia | 30062 | United States |
| GSK Investigational Site | Nampa | Idaho | 83686 | United States |
| GSK Investigational Site | DeKalb | Illinois | 60115 | United States |
| GSK Investigational Site | Arkansas City | Kansas | 67005 | United States |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | United States |
| GSK Investigational Site | Bossier City | Louisiana | 71111 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21021 | United States |
| GSK Investigational Site | Fall River | Massachusetts | 02724 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64108 | United States |
| GSK Investigational Site | Great Falls | Montana | 59405 | United States |
| GSK Investigational Site | Henderson | Nevada | 89015 | United States |
| GSK Investigational Site | Utica | New York | 13502 | United States |
| GSK Investigational Site | Cary | North Carolina | 27518 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45245 | United States |
| GSK Investigational Site | Dayton | Ohio | 45406 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74127 | United States |
| GSK Investigational Site | Gresham | Oregon | 97030 | United States |
| GSK Investigational Site | East Norriton | Pennsylvania | 19401 | United States |
| GSK Investigational Site | Rydal | Pennsylvania | 19046 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406 | United States |
| GSK Investigational Site | Bristol | Tennessee | 37620 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Corpus Christi | Texas | 78411 | United States |
| GSK Investigational Site | Layton | Utah | 84041 | United States |
| GSK Investigational Site | Provo | Utah | 84604 | United States |
| GSK Investigational Site | Springville | Utah | 84663 | United States |
| GSK Investigational Site | St. George | Utah | 84790 | United States |
| GSK Investigational Site | West Jordan | Utah | 84088 | United States |
| GSK Investigational Site | Virginia Beach | Virginia | 23454 | United States |
| GSK Investigational Site | Huntington | West Virginia | 25701 | United States |
| GSK Investigational Site | Bayamón | 00959 | Puerto Rico |
| GSK Investigational Site | San German | 00683 | Puerto Rico |
| GSK Investigational Site | San Juan | 00936-5067 | Puerto Rico |
| Berry 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111870 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111870 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111870 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111870 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111870 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111870 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Priorix 2 Group | 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. |
| FG002 | Priorix 3 Group | 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. |
| FG003 | MMR-II Group | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Priorix 1 Group | 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. |
| BG001 | Priorix 2 Group | 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. |
| BG002 | Priorix 3 Group | 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. |
| BG003 | MMR-II Group | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Number | Subjects | At Day 42 after administration of a dose of Priorix vaccine. |
|
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| Primary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Number | Subjects | At Day 42 after administration of a dose of Priorix vaccine. |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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 the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Number | Subjects | At Day 42 after administration of a dose of Priorix vaccine. |
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| Secondary | 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). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Number | Subjects | At Day 42 after administration of a dose of Varivax vaccine. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Day 42 after administration of a dose of Priorix vaccine. |
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| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 42 after administration of a dose of Priorix vaccine. |
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| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Day 42 after administration of a dose of Priorix vaccine. |
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| Secondary | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 42 after vaccination |
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| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Day 42 after administration of a dose of Varivax vaccine. |
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| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Day 42 after administration of a dose of Havrix vaccine. |
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| Secondary | 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). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Number | Subjects | At Day 42 after administration of a dose of Havrix vaccine. |
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| Secondary | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 0 before vaccination |
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| Secondary | 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 based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 1 year post-vaccination |
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| Secondary | 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 based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 2 years post-vaccination |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At 2 years post-vaccination |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At 1 year post-vaccination |
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| Secondary | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom. | Posted | Number | Subjects | During the 43-day (Days 0-42) post-vaccination period |
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| Secondary | 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. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom. | Posted | Number | Subjects | During the 43-day (Days 0-42) post-vaccination period |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 year post-vaccination |
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| Secondary | Number of Subjects Reporting Other Rash. | Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom. | Posted | Number | Subjects | During the 43-day (Days 0-42) post-vaccination period |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 1 year post-vaccination |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 1 year post-vaccination |
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| Secondary | 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 based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 2 years post-vaccination |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At 1 year post-vaccination |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At 2 years post-vaccination |
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| Secondary | 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. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom. | Posted | Number | Subjects | During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period |
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| Secondary | Number of Subjects With Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom. | Posted | Number | Subjects | During the 4-day (Days 0-3) post-vaccination period |
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| Secondary | 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. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | Number | Subjects | During the 43-day (Days 0-42) post-vaccination period |
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| Secondary | 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. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | Number | Subjects | During the 43-day (Days 0-42) post-vaccination period |
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| Secondary | Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling. | Swelling with accompanying general symptoms | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom. | Posted | Number | Subjects | During the 43-day (Days 0-42) post-vaccination period |
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| Secondary | 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. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom. | Posted | Number | Subjects | During the 15-day (Days 0-14) post-vaccination period |
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| Secondary | Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs). | NOCIs included autoimmune disorders, asthma, type I diabetes, allergies. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | Number | Subjects | From Day 0 to Day 180 after vaccination |
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| Secondary | 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. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | Number | Subjects | From Day 0 to Day 180 after vaccination |
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| Secondary | 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. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | Number | Subjects | From Day 180 to Day 730 after vaccination |
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| Secondary | Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. | The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | Number | Subjects | From Day 0 to Day 180 after vaccination |
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| Secondary | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | Antibody titers were expressed as Geometric Mean Titer (GMT). | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 1 year post-vaccination |
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| Secondary | 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). | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 1 year post-vaccination |
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| Secondary | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | Antibody concentrations are expressed as Geometric Mean Titer (GMT). | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 2 years post-vaccination |
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| Secondary | 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). | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 2 years post-vaccination |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | At 1 year post-vaccination |
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| Secondary | 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) | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 1 year post-vaccination |
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| Secondary | 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. | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | At 2 years post-vaccination |
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| Secondary | 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) | The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules. | Posted | Number | Subjects | At 2 years post-vaccination |
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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).
Solicited symptoms were only assessed on subjects returning the symptom sheet.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Priorix 1 Group | 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. | 0 | 304 | 1 | 304 | 240 | 304 |
| EG001 | Priorix 2 Group | 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. | 0 | 304 | 7 | 304 | 216 | 304 |
| EG002 | Priorix 3 Group | 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. | 0 | 304 | 8 | 304 | 219 | 304 |
| EG003 | MMR-II Group | 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. | 0 | 308 | 10 | 308 | 221 | 308 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Hypoxia | General disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Coxsackie viral infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Croup infectious | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Extremity necrosis | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Febrile convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| H1N1 influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Inflenza like illness | General disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Intussusception | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Otitis media acute | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Rash | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Respiratory syncitial virus infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Ataxia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment | Numbers correspond to all available data at the time of analysis of the active phase of the study. |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Intussusception | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Influenza like illness | General disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Bronchiolitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Coxsackie viral infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| H1N1 influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Ataxia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Febrile convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Extremity necrosis | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment | From the beginning of the study (Day 0) up to Day 180. |
|
| Nephroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment | SAE reported between Day 180 and Day 730 post-vaccination. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Accidental exposure to product by child | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Auricular pseudocyst | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bacterial test negative | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Crying | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dark circles under eyes | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Eye allergy | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Feeding disorder of infancy or early childhood | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Genital cyst | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Infected bites | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ketonuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Penile adhesion | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Tooth discolouration | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012409 | Rubella |
| D009107 | Mumps |
| D008457 | Measles |
| ID | Term |
|---|---|
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018185 | Morbillivirus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022362 | Hepatitis A Vaccines |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014761 | Viral Hepatitis Vaccines |
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D017778 | Vaccines, Combined |
Not provided
Not provided
| Male |
|
| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
|
|
| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
|
|
| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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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.
| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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| OG002 | Priorix 3 Group | 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. |
| OG003 | MMR-II Group | 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. |
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