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Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00861744
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : November 4, 2011
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE March 12, 2009
First Posted Date  ICMJE March 13, 2009
Results First Submitted Date  ICMJE July 14, 2011
Results First Posted Date  ICMJE November 4, 2011
Last Update Posted Date January 3, 2020
Actual Study Start Date  ICMJE June 3, 2009
Actual Primary Completion Date July 21, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
  • Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. [ Time Frame: At Day 42 after administration of a dose of Priorix vaccine. ]
    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
  • Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value. [ Time Frame: At Day 42 after administration of a dose of Priorix vaccine. ]
    Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.
  • Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. [ Time Frame: At Day 42 after administration of a dose of Priorix vaccine. ]
    Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
  • Anti-measles virus antibody concentration (in the serum of subjects below the cut-off before vaccination, lot by lot) [ Time Frame: Day 0 and Day 42 ]
  • Anti-mumps virus antibody titer (in the serum of subjects below the cut-off before vaccination, lot by lot) [ Time Frame: Day 0 and Day 42 ]
  • Anti-rubella virus antibody concentration (in the serum of subjects below the cut-off before vaccination lot by lot) [ Time Frame: Day 0 and Day 42 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value. [ Time Frame: At Day 42 after administration of a dose of Varivax vaccine. ]
    Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
  • Anti-measles Virus Antibody Concentrations [ Time Frame: At Day 42 after administration of a dose of Priorix vaccine. ]
    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.
  • Anti-mumps Virus Antibody Concentrations [ Time Frame: At Day 42 after administration of a dose of Priorix vaccine. ]
    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.
  • Anti-rubella Virus Antibody Concentrations [ Time Frame: At Day 42 after administration of a dose of Priorix vaccine. ]
    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.
  • Anti-S. Pneumoniae Antibody Concentrations (by Serotype). [ Time Frame: At Day 42 after vaccination ]
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
  • Anti-varicella Antibody Concentrations. [ Time Frame: At Day 42 after administration of a dose of Varivax vaccine. ]
    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.
  • Anti-hepatitis A Virus Antibody Concentrations. [ Time Frame: At Day 42 after administration of a dose of Havrix vaccine. ]
    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.
  • Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value. [ Time Frame: At Day 42 after administration of a dose of Havrix vaccine. ]
    Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
  • Anti-S. Pneumoniae Antibody Concentrations (by Serotype). [ Time Frame: At Day 0 before vaccination ]
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
  • Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value [ Time Frame: At 1 year post-vaccination ]
    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
  • Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value [ Time Frame: At 2 years post-vaccination ]
    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
  • Anti-measles Virus Antibody Concentrations [ Time Frame: At 2 years post-vaccination ]
    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.
  • Anti-measles Virus Antibody Concentrations [ Time Frame: At 1 year post-vaccination ]
    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.
  • Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
  • Number of Subjects Reporting Febrile Convulsions [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    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.
  • Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN)) [ Time Frame: At 1 year post-vaccination ]
    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.
  • Number of Subjects Reporting Other Rash. [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature
  • Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN) [ Time Frame: At 1 year post-vaccination ]
    Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
  • Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. [ Time Frame: At 1 year post-vaccination ]
    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.
  • Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. [ Time Frame: At 2 years post-vaccination ]
    Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
  • Anti-rubella Virus Antibody Concentrations [ Time Frame: At 1 year post-vaccination ]
    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.
  • Anti-rubella Virus Antibody Concentrations [ Time Frame: At 2 years post-vaccination ]
    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.
  • Number of Subjects Reporting Fever. [ Time Frame: During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period ]
    fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.
  • Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Solicited local symptoms assessed were pain, redness and swelling.
  • Number of Subjects Reporting Medically Attended Visit (MAEs) [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    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.
  • Number of Subjects With Unsolicited Adverse Events (AEs). [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    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.
  • Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling. [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    Swelling with accompanying general symptoms
  • Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 15-day (Days 0-14) post-vaccination period ]
    Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
  • Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs). [ Time Frame: From Day 0 to Day 180 after vaccination ]
    NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Day 180 after vaccination ]
    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.
  • Number of Subjects Reporting Serious Adverse Events (SAEs). [ Time Frame: From Day 180 to Day 730 after vaccination ]
    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.
  • Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. [ Time Frame: From Day 0 to Day 180 after vaccination ]
  • Anti-mumps Virus Antibody Titers (Unenhanced PRN) [ Time Frame: At 1 year post-vaccination ]
    Antibody titers were expressed as Geometric Mean Titer (GMT).
  • Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) [ Time Frame: At 1 year post-vaccination ]
    Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
  • Anti-mumps Virus Antibody Titers (Unenhanced PRN) [ Time Frame: At 2 years post-vaccination ]
    Antibody concentrations are expressed as Geometric Mean Titer (GMT).
  • Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) [ Time Frame: At 2 years post-vaccination ]
    Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
  • Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA) [ Time Frame: At 1 year post-vaccination ]
    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.
  • Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) [ Time Frame: At 1 year post-vaccination ]
    Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
  • Anti-mumps Virus Antibody Concentrations (PPD ELISA) [ Time Frame: At 2 years post-vaccination ]
    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.
  • Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) [ Time Frame: At 2 years post-vaccination ]
    Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
  • Anti-mumps virus antibody titer (in the serum of subjects below the cut-off before vaccination, pooled lots) [ Time Frame: Day 0 and Day 42 ]
  • Anti-rubella virus antibody concentration (in the serum of subjects below the cut-off before vaccination, pooled lots) [ Time Frame: Day 0 and Day 42 ]
  • Anti-varicella antibody concentration (in the serum of subjects below the cut-off before vaccination) [ Time Frame: Day 0 and Day 42 ]
  • Concentrations/titers of antibody to measles, mumps, rubella and varicella [ Time Frame: Day 0 and Day 42 ]
  • Concentrations/titers of antibody to measles, mumps, rubella and varicella [ Time Frame: 1 year post-vaccination ]
  • Anti-measles, anti-mumps, and anti-rubella antibody titer/concentration (in the serum of subjects below the cut-off before vaccination) [ Time Frame: 1 year post-vaccination ]
  • Concentrations/titers of antibody to measles, mumps, rubella and varicella [ Time Frame: 2 years post-vaccination ]
  • Anti-measles, anti-mumps, and anti-rubella antibody titer/concentration (in the serum of subjects below the cut-off before vaccination) [ Time Frame: 2 years post-vaccination ]
  • Anti-measles virus antibody concentration (in the serum of subjects below the cut-off before vaccination, pooled lots) [ Time Frame: Day 0 and Day 42 ]
  • Occurrence of solicited injection site symptoms (local) (pain, redness, swelling) [ Time Frame: 4-days after vaccination. ]
  • Occurrence of fever [ Time Frame: Over 15 days and over 43 days after vaccination. ]
  • Occurrence of investigator-confirmed measles/rubella-like rash and varicella-like rash [ Time Frame: Over 43 days after vaccination. ]
  • Occurrence of other rash (i.e. rash not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature) [ Time Frame: Over 43 days after vaccination. ]
  • Occurrence of investigator-confirmed parotid/salivary gland swelling [ Time Frame: Over 43 days after vaccination. ]
  • Occurrence of drowsiness, loss of appetite and irritability [ Time Frame: Over 15 days after vaccination. ]
  • Occurrence and timing of febrile convulsions [ Time Frame: Over 43 days after vaccination. ]
  • Occurrence of unsolicited symptoms and medically-attended adverse events (excluding rash and parotid/salivary gland swelling) and febrile convulsions [ Time Frame: Over 43 days after vaccination. ]
  • Occurrence of new onset chronic illnesses and conditions prompting ER visits [ Time Frame: Approximately 6 months after vaccination ]
  • Occurrence of all serious adverse events (SAEs) [ Time Frame: Approximately 6 months after vaccination ]
  • Occurrence of serious adverse events (SAEs) related to study participation, prompting study withdrawal and/or leading to death [ Time Frame: Between Day 180/Visit 3 and Day 730/Visit 5. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
Official Title  ICMJE A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.
Brief Summary

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Rubella
  • Mumps
  • Measles
  • Measles-Mumps-Rubella Vaccine
Intervention  ICMJE
  • Biological: GSK Biological's investigational vaccine 209762
    Subcutaneous injection, one dose
  • Biological: M-M-R® II (Merck and Co)
    Subcutaneous injection, one dose
  • Biological: Varivax®
    Subcutaneous injection, one dose
  • Biological: Havrix®
    Intramuscular injection, one dose
  • Biological: Prevnar®
    Intramuscular injection, one dose
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Biological: GSK Biological's investigational vaccine 209762
    • Biological: Varivax®
    • Biological: Havrix®
    • Biological: Prevnar®
  • Experimental: 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.
    Interventions:
    • Biological: GSK Biological's investigational vaccine 209762
    • Biological: Varivax®
    • Biological: Havrix®
    • Biological: Prevnar®
  • Experimental: 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.
    Interventions:
    • Biological: GSK Biological's investigational vaccine 209762
    • Biological: Varivax®
    • Biological: Havrix®
    • Biological: Prevnar®
  • Active Comparator: 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.
    Interventions:
    • Biological: M-M-R® II (Merck and Co)
    • Biological: Varivax®
    • Biological: Havrix®
    • Biological: Prevnar®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2011)
1259
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2009)
1200
Actual Study Completion Date  ICMJE June 18, 2012
Actual Primary Completion Date July 21, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
  • Written informed consent obtained from the parent/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
  • History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Hypersensitivity to latex
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures, including febrile seizures.
  • Acute disease at the time of enrolment.
  • Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 15 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00861744
Other Study ID Numbers  ICMJE 111870
2011-005860-31 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=3669
Current Responsible Party GlaxoSmithKline
Original Responsible Party Study Director, GSK
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP