Prevention of influenza
Conditions
Interventions
Serum antibody titers obtained prior to vaccination and 21-28 days after the first and second dose of quadrivalent influenza vaccine were tested, and adverse events were reported.
Serum antibody titer
Sponsors
National Hospital Organization Mie Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects aged 6 months to 18 years old at the time of first vaccination. 2) Subjects who are able to follow the regulation of the trial and written informed consent can be obtained from their legal guardian.
Exclusion criteria
Exclusion criteria: 1)Subjects with the history of influenza infection within 6 months (counted from the date of vaccination). (obtained by guardians) 2)Subjects vaccinated with influenza vaccine within 6 months (counted from the date of vaccination). 3)Subjects who had history of anaphylaxy to foods or medicines previously. 4)Subjects with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording. 5)Subjects with a history of Guillain-Barre syndrome, acute disseminated encephalomyelitis, thrombocytopenic purpura, thrombocytopenia, anaphylactoid purpura, encephalitis,encephalopathy and myelitis in the past. 6)Subjects vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine,toxoid within six days (counting from the date of vaccination). 7)Subjects received with gamma globulin or blood transfusion within three months, or received the formulation of high dose of gamma globulin therapy (200 mg / kg or more) within six months (counting from the date of vaccination). 8)Subjects judged as inadequate by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum antibody titers were measured prior to the first injection and the second injection (21plus-minus7days starting with the first injection) and 21 days after the second dose(HI antibody against influenza A and B) | — |
Countries
Japan
Contacts
Public ContactSHIGERU SUGA
National Hospital Organization Mie Hospital Instisute for Clinical Research
Outcome results
None listed