Study to evaluate immunogenicity and safety of GSK Biologicals’ measles, mumps, rubella and varicella (MMRV) freezer-stored (MMRVF) & refrigerator-stored (MMRVR) vaccine formulations vs. ProQuad in infants 12-14 months of age when co-administered with hepatitis A and pneumococcal conjugate vaccines.
- Conditions
- Healthy volunteers (Use of the candidate MMRV vaccine for immunization of healthy children 12 - 14 months of age against measles, mumps, rubella and varicella).Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-000454-18-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 1851
• Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• Male or female between 12 and 14 months of age at the time of first 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 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1851
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Use of any investigational or non-registered product 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.
• Chronic administration 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.
• 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 and/or varicella/zoster 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, 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.
• Use of any investigational or non-registered product 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.
• Chronic administration 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.
• 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 and/or varicel-la/zoster 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, including human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be ex-acerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures. Un-complicated febrile convulsions are not an exclusion criterion.
• Residence in the same household as the following persons:
?- New-born infants (0-4 weeks of age).
?- Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
?- Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
?- Persons with known immunodeficiency.
• Acute disease at the time of enrolment. All vaccines can be administered
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method