Immunogenicity & Safety of Hepatitis A Vaccine co-admin with a Measles/Mumps/Rubella & a Varicella Vaccine in Children
Trial overview
Anti-hepatitis A virus (HAV) antibody concentrations in HAV and HAV+MMR+V groups.
Timeframe: 31 days following the second dose of Havrix®
Number of subjects with anti-hepatitis A virus (HAV) antibody concentration equal or above the cut-off value in HAV and HAV+MMR+V groups
Timeframe: 31 days following the second dose of Havrix®
Number of subjects seroconverted for anti-measle, anti-mumps and anti-varicella antibodies in HAV+MMR+V and MMR+V→HAV groups
Timeframe: 42 days following the administration of M-M-R®II and VARIVAX®
Number of subjects with vaccine response for anti-rubella antibodies in HAV+MMR+V and MMR+V→HAV groups
Timeframe: 42 days following administration of M-M-R®II and VARIVAX®
Anti-measles, anti-mumps, anti-rubella and anti-varicella antibody titers in HAV+MMR+V and MMR+V→HAV groups
Timeframe: 42 days following the administration of M-M-R®II and VARIVAX®
Anti-hepatitis A virus (HAV) antibody concentrations in HAV and HAV+MMR+V groups
Timeframe: 42 days following the first dose of Havrix®
Number of subjects with anti-hepatitis A virus (HAV) antibody concentration equal or above the cut-off value in HAV and HAV+MMR+V groups
Timeframe: 42 days following the first dose of Havrix®
Anti-hepatitis A virus (HAV) antibody concentrations in MMR+V→HAV Group
Timeframe: 31 days following the second dose of Havrix®
Number of subjects with anti-hepatitis A virus (HAV) antibody concentrations above the cut-off value in MMR+V→HAV Group
Timeframe: 31 days following the second dose of Havrix®
Number of subjects with vaccine response to Havrix®
Timeframe: 31 days following the second dose of Havrix®
Number of subjects reporting solicited local symptoms
Timeframe: During the 4-day period following each dose of vaccine
Number of subjects reporting solicited general symptoms
Timeframe: During the 4-day period following each dose of vaccine
Number of subjects reporting measles, mumps, rubella and varicella specific solicited general adverse events
Timeframe: During the 43-day period following each dose of vaccine
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: During the 31-day period following each dose of vaccine
Number of subjects reporting serious adverse events (SAEs)
Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
Number of subjects reporting new chronic illnesses
Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
Number of subjects reporting medically significant events
Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
- Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
- A male or female child 12 and 13 months of age at the time of entry into the Enrollment Phase
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use during the study period,
- Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.)
•Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol •A male or female child 12 and 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
•Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.) 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 vaccine(s). •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 immunodeficient condition, including human immunodeficiency virus (HIV) 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 HavrixTM, M-M-RII or VARIVAXTM, 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 HavrixTM needleless pre-filled syringes contain dry natural latex rubber. •Major congenital defects or serious chronic illness, •Active untreated tuberculosis, •History of significant blood dyscrasias •History of any neurologic disorder (a history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject) •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
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.