Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 July 2015 |
Main ID: |
EUCTR2011-004891-12-ES |
Date of registration:
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01/03/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Consistency study of GlaxoSmithKline (GSK) Biologicals? MMR vaccine (209762) (Priorix®) comparing immunogenicity and safety to Merck & Co., Inc.?s MMR vaccine (M-M-R®II), in children 12 to 15 months of age.
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Scientific title:
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A phase IIIA, randomized, observer-blind, controlled, multinational consistency study to evaluate the immunogenicity and safety of GSK Biologicals' MMR vaccine (209762) (Priorix®) compared to Merck & Co., Inc.?s MMR vaccine (M-M-R®II), as a first dose, both co-administered with Varivax, Havrix and Prevnar 13 (subset of children) to healthy children 12 to 15 months of age. - MMR-160 |
Date of first enrolment:
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21/05/2013 |
Target sample size:
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4000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004891-12 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 5
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Phase:
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Countries of recruitment
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Argentina
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Estonia
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Finland
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Mexico
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Spain
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United States
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Contacts
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Name:
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Clinical Disclosure Advisor
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Address:
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Rue de l'Institut, 89
1330
Rixensart
Belgium |
Telephone:
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442089904466 |
Email:
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GSKClinicalSupportHD@gsk.com |
Affiliation:
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GlaxoSmithKline Biologicals |
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Name:
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Clinical Disclosure Advisor
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Address:
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Rue de l'Institut, 89
1330
Rixensart
Belgium |
Telephone:
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442089904466 |
Email:
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GSKClinicalSupportHD@gsk.com |
Affiliation:
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GlaxoSmithKline Biologicals |
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Key inclusion & exclusion criteria
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Inclusion criteria: ?Male or female child between 12 and 15 months of age at the time of vaccination. ?The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol. ?Written informed consent obtained from the parent(s)/LAR(s) of the child. ?Child is in stable health as determined by investigator?s clinical examination and assessment of child?s medical history. For US children only: ?Child that previously received a 3-dose series of Prevnar 13 only (i.e., no doses given as Prevnar/Prevenar), at least 60 days prior to study entry. Are the trial subjects under 18? yes Number of subjects for this age range: 5000 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria: ?Child in care. ?Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study period. ?Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product. ?Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. -For corticosteroids, this will mean prednisone, ?0.5 mg/kg/day or equivalent. -Inhaled and topical steroids are allowed. ?Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2. Please Note: -Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s). -Any age appropriate vaccine may be given starting at Visit 2 and anytime thereafter. ?Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2. ?History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease. ?Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to first study vaccination. ?Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus. ?Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. ?A family history of congenital or hereditary immunodeficiency. ?History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin. ?Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. ?Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever. ?Active untreated tuberculosis based on medical history. ?Any other condition which, in the opinion of the investigator, prevents the child from participating in the study. For US children only: ?Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior vaccination should be with 3 doses of Prevnar 13 only). ?Child that previously received a fourth dose of any pneumococcal conjugate vaccine.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy children in their second year of life). MedDRA version: 15.1
Level: PT
Classification code 10028257
Term: Mumps
System Organ Class: 10021881 - Infections and infestations
MedDRA version: 15.1
Level: SOC
Classification code 10021881
Term: Infections and infestations
System Organ Class: 10021881 - Infections and infestations
MedDRA version: 15.1
Level: PT
Classification code 10039252
Term: Rubella
System Organ Class: 10021881 - Infections and infestations
MedDRA version: 15.1
Level: PT
Classification code 10027011
Term: Measles
System Organ Class: 10021881 - Infections and infestations
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Intervention(s)
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Trade Name: PRIORIX Product Name: Priorix Product Code: 209762 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Virus vivos atenuados del sarampión (cepa Schwarz) Other descriptive name: Virus vivos atenuados del sarampión (cepa Schwarz Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose Concentration type: not less then Concentration number: 3.0- INN or Proposed INN: Virus vivos atenuados de la parotiditis (cepa RIT4385) Other descriptive name: VACUNA DE VIRUS VIVOS DE LA PAROTIDITIS (JERYL LYNN) Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose Concentration type: not less then Concentration number: 3.7- INN or Proposed INN: Virus vivos atenuados de la rubeola (cepa Wistar RA 27/3) Other descriptive name: CEPA WISTAR RA 27/3 DEL VIRUS DE LA RUBEOLA (VIVA, ATENUADA PRODUCIDA EN CÉLULAS DIPLOIDES HUMANAS (MRC-5) Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose Concentration type: not less then Concentration number: 3.0-
Trade Name: VARIVAX Product Name: Varivax Pharmaceutical Form: Powder and solvent in pre-filled syringe for solution for injection INN or Proposed INN: Varicela viva atenuada (cepa OKA/Merck) Other descriptive name: Cepa OKA/MERCK del virus de la varicella (vivo, atenuado) Concentration unit: PFU plaque forming unit Concentration type: not less then Concentration number: 1350-
Trade Name: HAVRIX 720, Junior Product Name: Havrix 720 Junior Pharmaceutical Form: Suspension for injection INN or Proposed INN: Antígeno del virus de la hepatitis A (VHA), HM 175 Other descriptive name: CEPA HM175 DEL VIRUS DE LA HEPATITIS A (INACTIVADA) (INACTIVATED) Concentration unit: ELISA unit/dose enzyme-linked immunosorbent assay unit/dose Concentration type: equal Concentration number: 720-
Trade Name: M-M-R VAXPRO Product Name: M-M-R VAXPRO Pharmaceutical Form: Powder and solvent for suspension for injection in pre-filled syringe INN o
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Primary Outcome(s)
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Secondary Objective: ?To demonstrate non-inferiority of the pooled Inv_MMR groups compared to the pooled Com_MMR groups in terms of seroresponse rate and GMC for varicella zoster virus (VZV) Abs at D 42 (in US children). ?To demonstrate non-inferiority of the pooled Inv_MMR compared to pooled Com_MMR groups in terms of GMC for hepatitis A virus (HAV) Abs at D 42 (in US). ?To demonstrate non-inferiority of the pooled Inv_MMR compared to pooled Com_MMR in terms of Abs to S. pneumoniae (PS) (13 serotypes), at D 42 (in US). ?To assess immunogenicity of Havrix with respect to the seroresponse rates for HAV Abs in pooled Inv_MMR in contrast to pooled Com_MMR at D 42 (in US). ?To assess immunogenicity of Prevnar 13 with respect to anti-PS Ab concs ? the cut-offs of 0.05, 0.2, 0.5, and 1.0 µg/mL for Abs to PS in the Inv_MMR or the Com_MMR at D 42 (in US). ?To assess safety and reactogenicity of Inv_MMR and Com_MMR when co-administered with Varivax, Havrix (to all children) and Prevnar 13 (in US).
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Primary end point(s): Immunogenicity of the MMR vaccines in terms of antibody concentration. ?Seroresponse to measles, mumps and rubella viruses (by ELISA). ?Measles, mumps and rubella virus antibody concentrations.
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Main Objective: ?To demonstrate the consistency of three manufacturing lots of Inv_MMR vaccine in terms of seroresponse rates to measles, mumps and rubella viruses at Day 42. ?To demonstrate the consistency of three manufacturing lots of Inv_MMR vaccine in terms of geometric mean concentrations (GMCs) for antibodies to measles, mumps and rubella viruses at Day 42. ?To demonstrate the non-inferiority of Inv_MMR (for the three pooled lots) compared to Com_MMR (for the two pooled lots) vaccine in terms of seroresponse rates for measles, mumps and rubella viruses at Day 42. ?To demonstrate non-inferiority of Inv_MMR (for the three pooled lots) compared to Com_MMR (for the two pooled lots) vaccine in terms of GMCs for antibodies to measles, mumps and rubella viruses at Day 42. ?To demonstrate an acceptable immune response for Inv_MMR in terms of seroresponse rates for measles, mumps and rubella viruses at Day 42.
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Timepoint(s) of evaluation of this end point: At Day 42
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Secondary Outcome(s)
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Secondary end point(s): Immunogenicity of the Varivax, Havrix and Prevnar 13 vaccines in a subset of children, in terms of antibody concentrations. ?Seroresponse to VZV. ?VZV antibody concentrations. ?HAV antibody concentrations. ?Seroresponse to HAV. ?Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) antibody concentrations. ?Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) antibody concentrations ?0.05 µg/mL, ?0.2 µg/mL, ?0.5 µg/mL and ?1.0 µg/mL.
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Timepoint(s) of evaluation of this end point: At Day 42
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Secondary ID(s)
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2011-004891-12-EE
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115648
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Source(s) of Monetary Support
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GlaxoSmithKline Biologicals
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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