Active immunization against hepatitis A of healthy children 15 months of age at the time of the first study vaccination.
Conditions
Interventions
Trade Name: M-M-R II
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: -
Current Sponsor code: ATTENUVAX
Other descriptive name: MEASLES VIRUS ENDERS' EDMONSTON
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol should be enrolled in the study. A male or female child 12 to 13 months of age at the time of entry into the Enrollment Phase. Written informed consent obtained from the parents or guardian of the subject, Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and Parents/guardian of the subject must have a telephone or be able to be contacted by telephone. Are the trial subjects under 18? yes Number of subjects for this age range: 1474 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 drug or vac-cine other than the study vaccines within 42 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration of immunosuppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period., Planned administration or administration of any vaccine not foreseen by the study protocol during the period 31 days before and 31 days after each dose of study vaccines. For subjects in the HAV Group ONLY, the first dose of M-M-RII and VARIVAX must be administered during the Enrollment Phase and >= 42 days prior to administration of study vaccine(s) at Day 0.] Previous vaccination against hepatitis A,History of hepatitis A, Known exposure to hepatitis A. Previous vaccination against measles, mumps, rubella and/or varicella, History of measles, mumps, rubella and/or varicella, Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study, Planned chronic use of salicylates during the 6-week period following administration of the doses of study vaccine(s), Any confirmed or suspected immunosuppressive or im-munodeficient condition, including human immunodeficiency virus infection, A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection, History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix, M-M-RII or VARIVAX, including 2-phenoxyethanol, neomycin and gelatin, History of anaphylactic or anaphylactoid reactions to egg proteins, History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the rubber plunger of the Havrix needle-less pre-filled syringes contain dry natural latex rubber. Major congenital defects or serious chronic illness, Active untreated tuberculosis, History of significant blood dyscrasias, e.g., leukemia, lymphomas, etc. History of any neurologic disorder Acute disease at the time of vaccination. Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period, i.e., the Enrollment, Active and Extended Safety Follow-up Phases of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of the anti-HAV immune response (with respect to both seropositivity rates and GMCs) 31 days following the second dose of Havrix when the first dose of Havrix is co-administered with M-M-RII and VARIVAX (HAV+MMR+V Group) compared to Havrix given alone (HAV Group), To demonstrate the non-inferiority of the anti-measles, anti-mumps, anti-rubella and anti-varicella immune responses (with respect to seroconversion rates for anti-measles, anti-mumps and anti-varicella and seroresponse rate for anti-rubella) 42 days following the co-administration of M-M-RII and VARIVAX with the first dose of Havrix (HAV+MMR+V Group) compared to when M-M-RII and VARIVAX are given alone (MMR+V?HAV Group). ;Secondary Objective: Anti-measles, anti-mumps, anti-rubella & anti-varicella immune responses 42 days following the co-ad. of M-M-RII and VARIVAX with dose 1 of Havrix in the HAV+MMR+V Group & the MMR+V?HAV Group. Anti-HAV immune response 42 days following dose 1 of Havrix in the HAV Group & the HAV+MMR+V Group, & 31 days following dose 2 of Havrix in the MMR+V?HAV Group. Vaccine response to Havrix 31 days following dose 2 of Havrix, all groups. Incidence & intensity of solicited local and general adverse events (AEs) during the 4-Day period following each dose & groups & using Diary Cards (DC)s. Incidence, intensity & causal relationship of MMR+V specific solicited general AEs the 43-Day period following ad. of dose 2), using DCs. Incidence, nature, intensity & causal relationship to vac-cination of unsolicited AEs & SAEs, new chronic illnesses & medically significant events following each dose & groups during the 31-Day follow-up period & during the Active & the Extended Safety Follow-up Phase. ;Primary end point(s): Anti-HAV GMCs and seropositivity rates following the second dose of Havrix in the HAV Group and the HAV+MMR+V Group. Anti-measles, anti-mumps and anti-varicella seroconversion rates and the anti-rubella seroresponse rate foll | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Anti-measles, anti-mumps, anti-rubella and anti-varicella GMCs following the administration of M-M-RII and VARIVAX in the HAV+MMR+V Group and the MMR+V?HAV Group. Anti-HAV GMCs and seropositivity rates following the first dose of Havrix in the HAV Group and the HAV+MMR+V Group. Anti-HAV GMCs and seropositivity rates following the second dose of Havrix in the MMR+V?HAV Group. Vaccine response to Havrix following the second dose in all three groups. Incidence and intensity of solicited local AEs. Incidence, intensity and causal relationship to vaccination of solicited general AEs. Incidence, intensity (where applicable) and causal relationship to vaccination of MMR+V specific solicited general AEs. Incidence, nature, intensity and causal relationship to vaccination of unsolicited AEs. Incidence, nature, intensity and causal relationship to vaccination of SAEs during the Enrollment Phase and SAEs, new chronic illnesses and medically significant events in each group during the Active Phase and the Extended Safety Follow-up Phase. ;Timepoint(s) of evaluation of this end point: For anti-measles, anti-mumps, anti-rubella and anti-varicella GMCs and anti-HAV GMCs and seropositivity rates : At Visit 3 (Day 42) For anti-HAV GMCs and seropositivity rates following the second dose of Havrix in the MMR+V?HAV Group and vaccine response to Havrix following the second dose in all three groups : At Visit 5. For incidence and intensity of solicited local and general AEs: During the 4-day period (Days 0-3) following each dose of study vaccine(s) in each group. For solicited general AEs: During the 43-day period (Days 0-42) following the first dose of study vaccine(s) in each group. For unsolicited AEs: During the 31-day period (Days 0-30) following each dose of study vaccines in each group. For SAEs: Month 0 to Month 16 (Active and extended follow-up phase) | — |
Countries
United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed