Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals? combined measles-mumps-rubella (MMR) vaccine in children in their second year of life.

• Register: EUCTR
• Last refreshed on: 19 October 2015
• Main ID: EUCTR2011-004905-26-ES
• Date of registration: 25/10/2012
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals? combined measles-mumps-rubella (MMR) vaccine in children in their second year of life.
• Scientific title: Immunogenicity and safety study of GSK Biologicals? Priorix® vaccine (209762) at an end of shelf-life potency compared to Merck & Co., Inc.?s MMR vaccine when both are given on a 2-dose schedule to healthy children in their 2nd year of life. - MMR-161
• Date of first enrolment: 19/12/2012
• Target sample size: 4500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004905-26
• 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: 4

Countries of recruitment

Czech Republic, Finland, Malaysia, Spain, Thailand, 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 at least 60 days prior to study entry.
Are the trial subjects under 18? yes
Number of subjects for this age range: 4500
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 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.
-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 (or ending at Visit 3 for the US post-dose 2 sub-cohort). 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 (or starting at Visit 3 for the US post-dose 2 sub-cohort), 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, or at Visit 3 for the US post-dose 2 sub-cohort.
?History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.
?Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the 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. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ?38°C/100.4°F by any age appropriate route. 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:
?A 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: 14.1 Level: PT Classification code 10028257 Term: Mumps System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1 Level: PT Classification code 10039252 Term: Rubella System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1 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: Virus vivo atenuado de la parotiditis (cepa RIT4385)
Other descriptive name: Vacuna de virus vivo 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: CEPA SCHWARZ DEL VIRUS DEL SARAMPIÓN (VIVA, ATENUADA)
Other descriptive name: CEPA SCHWARZ DEL VIRUS DEL SARAMPIÓN (VIVA, ATENUADA
Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose
Concentration type: not less then
Concentration number: 2.9-
INN or Proposed INN: CEPA WISTAR RA 27/3 DEL VIRUS DE LA RUBEOLA (VIVA, ATENUADA)
Other descriptive name: CEPA WISTAR RA 27/3 DEL VIRUS DE LA RUBEOLA (VIVA, ATENUADA)
Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose
Concentration type: not less then
Concentration number: 2.9-

Trade Name: VARIVAX
Product Name: Varivax
Pharmaceutical Form: Powder and solvent in pre-filled syringe for solution for injection
INN or Proposed INN: Virus vivo atenuado de la varicela (cepa OKA/Merck)
Other descriptive name: Cepa OKA/MERCK del virus dela varicela (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)
Concentration unit: ELISA unit/dose enzyme-linked immunosorbent assay unit/dose
Concentration type: equal
Concentration number: 720-

Trade Name: M-M-RVAXPRO
Product Name: M-M-RVAXPRO
Pharmaceutical Form: Powder and solvent for suspension for injection in pre-filled syringe
INN or Proposed INN: CEPA ENDERS' EDMONSTON DEL VIRU

Primary Outcome(s)

Primary end point(s): Immunogenicity of the MMR vaccines:
?Seroresponse to measles, mumps and rubella viruses (by ELISA) and to mumps virus (by PRNT).
?Measles, mumps and rubella virus antibody concentrations (by ELISA) and mumps virus antibody titers (by PRNT).

Main Objective: ?To demonstrate non-inferiority of Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of seroresponse rates to MMR viruses at Day 42.
?To demonstrate non-inferiority of Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of geometric mean concentrations (GMCs) for antibodies to MMR viruses at Day 42.
?To demonstrate an acceptable immune response of Inv_MMR vaccine in terms of seroresponse rates for MMR viruses at Day 42.
?To demonstrate non-inferiority of the Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of seroresponse rates for mumps virus (by Plaque Reduction Neutralization Test (PRNT)) at Day 42.
?To demonstrate non-inferiority of the Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of geometric mean titer (GMT) for antibodies to mumps virus (by PRNT) at Day 42.

Secondary Objective: ?To assess the immunogenicity of Inv_MMR_Min and pooled Com_MMR vaccine in terms of seroresponse rates and GMCs for antibodies to measles, mumps and rubella viruses at Day 84 (post Dose 2) (in a sub-cohort of children enrolled in the US).
?To assess the immunogenicity of Inv_MMR_Med and pooled Com_MMR vaccine in terms of seroresponse rate and GMCs for antibodies to measles, mumps and rubella viruses at Day 84 (post Dose 2) (in a sub-cohort of children enrolled in the US).
?To assess the safety and reactogenicity of Inv_MMR_Min, Inv_MMR_Med, and Com_MMR when co-administered with Varivax, Havrix (to all children), and Prevnar 13 (only to children enrolled in the US).

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

Secondary Outcome(s)

Secondary end point(s): Immunogenicity of the MMR vaccines post-dose 2 (US post-dose 2 sub-cohort). In terms of antibody concentration:
?Seroresponse to measles, mumps and rubella viruses (by ELISA).
?Measles, mumps and rubella virus antibody concentrations (by ELISA)

Timepoint(s) of evaluation of this end point: At Day 84

Secondary ID(s)

115649

2011-004905-26-FI

Source(s) of Monetary Support

GlaxoSmithKline Biologicals