Healthy children between 12-22 months (including the day before the 23-month birthday) of age at the time of vaccination with no history of measles, mumps, rubella and varicella diseases/vaccination. MedDRA version: 14.1 Level: PT Classification code 10028257 Term: Mumps System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10046980 Term: Varicella System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT
Conditions
Interventions
Product Name: Priorix-Tetra
Product Code: MeMuRu-OKA
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Live attenuated mumps vaccine, Jeryl Lynn strain
Other desc
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) for the whole duration of the study. - Male or female subject between 12 and 22 months (including the day before the 23-month birthday) of age at the time of the first vaccination. - Subjects free of obvious health problems, as established by medical history and physical examination before entering the study. - Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure. - Subjects whose parents/guardians have direct access to telephone/mobile phone (either at home or at work). - Subjects: (1) with at least one sibling (with negative history of varicella disease/vaccination) at home, or (2) attending day care center (subjects who are registered for attendance at day care center from 24 months of age may be considered for inclusion in the study), or (3) attending childminders, i.e. someone taking care of several children (with at least one child without a known positive history of varicella disease/vaccination), or (4) who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes. Are the trial subjects under 18? yes Number of subjects for this age range: 5754 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: - Previous vaccination against measles, mumps, rubella and/or varicella. - History of previous 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. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day). Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - Family history of congenital or hereditary immunodeficiency. - History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin. - Major congenital defects or serious chronic illness. - Residence in the same household as newborns (0-4 weeks of age), pregnant mothers varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella (At any point in time when such exclusion criterium becomes not applicable, potential study participants may come back at a later stage for study inclusion). - History of any neurologic disorders or seizures. - Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period. Additional exclusion criteria for subjects included in the subset: - Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To demonstrate the efficacy of one dose of Varilrix in preventing confirmed varicella cases over at least two years after vaccination. OR/AND - To demonstrate the efficacy of two doses of Priorix™-Tetra in preventing confirmed varicella cases over at least two years after vaccination. ;Secondary Objective: - Long-term efficacy of Varilrix or Priorix™-Tetra in preventing confirmed varicella cases. (Phase B) - Efficacy of Varilrix or Priorix™-Tetra in preventing probable or confirmed varicella cases (Phase A & B) - Efficacy based on varicella severity (Phase A & B) - Assessment of complicated varicella cases (Phase A & B) - Immune response to varicella (seroconversion/seropositivity & GMT) at 42 days, one, two, four, six, eight and ten years after the last vaccination (Phase A & B) - Immune response to MMR (seroconversion/seropositivity & GMT) at 42 days (after each vaccination), one, two, four, six, eight and ten years after the last vaccination (subset) (Phase A & B) - Safety of the vaccines (SAEs, herpes zoster descriptions) (Phase A & B) - Solicited (local/general)/unsolicited symptoms at 42 days after each vaccination (subset) (Phase A) - Factors leading to indirect cost of varicella (Phase A & B) ;Primary end point(s): - Occurrence of confirmed varicella cases in all subjects 42 days post dose 2 until the end of Phase A.;Timepoint(s) of evaluation of this end point: from 42 days post dose 2 until the end of Phase A. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Phase A Efficacy: •Occurrence of probable or confirmed varicella cases in all subjects from 42 days post dose 2 until the end of Phase A. •Occurrence of varicella cases by severity in all subjects from 42 days post dose 2 until the end of Phase A. •Occurrence of complicated varicella cases (reported as SAEs) in all subjects. Immunogenicity: •Varicella antibody titres in all subjects at Day 0, Day 84, Year 1 and Year 2 time points. •Measles, mumps and rubella antibody titres in a subset of subjects at Day 0, Day 42, Day 84, Year 1 and Year 2 time points. Safety: •Occurrence of SAEs in all subjects from Day 0 until the end of Phase A. •Occurrence of herpes zoster in all subjects from Day 0 until the end of Phase A. In a subset of subjects: -Occurrence of fever (>=37.5 °C axillary/>=38.0 °C rectal route) from Day 0 to Day 42 after each dose. -Occurrence of any and grade 3 solicited local symptoms within 4 days after each vaccination (Day 0-3 after each dose). -Occurrence of any and grade 3 solicited general symptoms (rash, any sign of meningism including febrile convulsion and parotitis/ salivary gland swelling) within 43 days after each vaccination (Day 0-42 after each dose). -Occurrence of unsolicited symptoms within 43 days after each vaccination (Day 0-42 after each dose). Health economics: •Number of hours/days lost from work by parents/guardians as a result of taking care of their child due to varicella during Phase A. •Number of hours/days the child lost attendance due to varicella in day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organized leisure activities) during Phase A. •Number of hours/days spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child due to varicella (if applicable) during Phase A. Phase B Efficacy: •Occurrence of confirmed varicella cases in all subjects from Year 2 (or end of Phase A, if later) to | — |
Countries
Czech Republic, Italy, Lithuania, Norway, Poland, Romania, Russian Federation, Slovakia, Slovenia, Sweden
Contacts
Public ContactClinical Disclosure Advisor
Clinical Trial Helpdesk
Outcome results
None listed