Healthy volunteers (Use of the candidate MMRV vaccine for immunization of healthy children 12 - 14 months of age against measles, mumps, rubella and varicella).
Conditions
Interventions
Trade Name: Priorix-Tetra
Product Code: MMR-V
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: -
Other descriptive name: MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTE
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the non-inferiority of GSK Biologicals’ MMRVR co-administered with HAV and PCV compared to ProQuad co-administered with HAV and PCV at Day 42 with respect to - the seroresponse rate for antibodies to -> varicella virus -> measles virus and rubella virus -> mumps virus - the geometric mean concentration (GMC) for anti-bodies to -> varicella virus -> hepatitis A virus in a subset of subjects -> S. pneumoniae serotypes (anti-PS) 4, 6B, 9V, 14, 18C, 19F and 23F in a subset of subjects • To demonstrate the non-inferiority of GSK Biologicals’ MMRVF co-administered with HAV and PCV compared to ProQuad co-administered with HAV and PCV at Day 42 with respect to - the seroresponse rate for antibodies to -> varicella virus -> measles virus and rubella virus -> mumps virus - GMC for antibodies to -> varicella virus -> hepatitis A virus in a subset of subjects -> anti-PS serotypes 4, 6B, 9V, 14, 18C, 19F and 23F in a subset of subjects ;Secondary Objective: • To evaluate GSK Biologicals MMRVR co-administered with HAV and PCV and ProQuad co-administered with HAV and PCV at Day 42 with respect to - the concentrations/titers of antibodies (Abs) to mumps virus, measles virus and rubella virus - the seroresponse rate of Abs to HAV in a subset of subjects - the percentage of subjects with anti-PS antibody concentrations = 0.05, =0.2, =0.5 and =1.0 µg/mL in a subset of subjects • To evaluate GSK Biologicals MMRVF co-administered with HAV and PCV and ProQuad co-administered with HAV and PCV at Day 42 with respect to - the concentrations/titers of Abs to mumps virus, measles virus and rubella virus - the seroresponse rate of Abs to HAV in a subset of subjects - the percentage of subjects with anti-PS antibody concentrations = 0.05, =0.2, =0.5 and =1.0 µg/mL in a subset of subjects • To assess safety and reactogenicity of GSK Biologicals MMRVR or MMRVF co-administered with HAV and PCV compared to ProQuad co-administered with HAV and PCV;Prima | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Concentrations/titers of antibodies to mumps, measles and rubella viruses. 2) Vaccine Response to HAV. 3) Seropositivity rate for anti-PS antibody. 4) Occurrence of MMRV/ ProQuad injection site (local) solicited symptoms (pain, redness, swelling). 5) Occurrence of fever 38.0°C/100.4°F and > 39.5°C/103.1°F. 6) Occurrence of investigator-confirmed measles/rubella-like rash. 7) Occurrence of investigator-confirmed varicella-like rash. 8) Occurrence of investigator-confirmed parotid/salivary gland swelling. 9) Occurrence of unsolicited symptoms and medically-attended adverse events (excluding rash and parotid/salivary gland swelling). 10) Occurrence of new onset chronic illnesses (e.g. autoimmune disorders, asthma, type I diabetes and allergies) and conditions prompting ER (Emergency Room) visits. 11) Occurrence of serious adverse events (SAEs). ;Timepoint(s) of evaluation of this end point: - For endpoints 1, 2 and 3 at 42 days post vaccination. - For endpoint 4 over 4 days post vaccination. - For endpoint 5 over 15 days and over 43 days post vaccination. - For endpoint 6, 7, 8 and 9 over 43 days post vaccination. - For endpoint 10 and 11 approximately 6 months (Day 0-180). | — |
Countries
United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed