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.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2011-004891-12-EE
• Date of registration: 04/10/2012
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: 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.
• Scientific title: 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: 02/11/2012
• Target sample size: 2900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004891-12
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Argentina, Estonia, Finland, Mexico, Spain, United States

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

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), with the last dose 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, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
-Any other 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 prior to study vaccination at Visit 1 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

Health Condition(s) or Problem(s) studied

Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy children in their second year of life).
MedDRA version: 18.0 Level: PT Classification code 10028257 Term: Mumps System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0 Level: PT Classification code 10039252 Term: Rubella System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0 Level: PT Classification code 10027011 Term: Measles System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Trade Name: PRIORIX
Product Name: Priorix
Product Code: 209762
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Live attenuated measles virus (Schwarz strain)
Other descriptive name: Live attenuated measles virus (Schwarz strain)
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: Live attenuated mumps virus (RIT4385 strain)
Other descriptive name: MUMPS VIRUS VACCINE LIVE (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: Live attenuated rubella virus (Wistar RA 27/3 strain)
Other descriptive name: RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS
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 for solution for injection
INN or Proposed INN: Life attenuated Varicella (OKA/Merck strain)
Other descriptive name: VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
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: Hepatitis A virus antigen (HAV), HM 175
Other descriptive name: HEPATITIS A VIRUS HM175 STRAIN (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 or Proposed INN: MEASLES VIRUS ENDERS' EDMONSTON STRAIN (LIVE, ATTENUATED)
Other descriptive name: ME

Primary Outcome(s)

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.

Secondary Objective: Non-inferiority of the pooled Inv_MMR groups compared to the pooled Com_MMR groups in terms of:
•Seroresponse rate and GMC for antibodies to VZV, GMC for antibodies to HAV at Day 42; (in a subset of children enrolled in the US) respectively.
•Antibodies to S. pneumoniae (PS) (13 serotypes), at Day 42 (in a subset of children administered Prevnar 13 in the US).
Immunogenicity of:
•Havrix with respect to the seroresponse rates for antibodies to HAV in the pooled Inv_MMR groups in contrast to the pooled Com_MMR vaccine groups at Day 42 (in a subset of children enrolled in the US).
•To assess:
•Safety and reactogenicity of Inv_MMR and Com_MMR when co-administered with Varivax, Havrix (to all children) and Prevnar 13 (only to children enrolled in the US).

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.

Timepoint(s) of evaluation of this end point: At Day 42

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At Day 42

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 varicella zoster virus (VZV).
•VZV antibody concentrations.
•Hepatitis A virus (HAV) antibody concentrations.
•Seroresponse to HAV.
•Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) antibody concentrations.

Secondary ID(s)

115648

Source(s) of Monetary Support

GlaxoSmithKline Biologicals