Influenza H5N1 prevention
Conditions
Interventions
investigational material(s)
Generic name etc : Emulsified Cell-Culture influenza HA vaccine (H5N1 strain)
INN of investigational material : -
Therapeutic category code : 631 Vaccines
Dosage and Admini
Sponsors
KM Biologics Co., Ltd.
GlaxoSmithKline K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who meet all of the following criteria are included. (1)Children aged 6 months to under 20 years at the time of obtaining informed consent (2)Those whose legal representative gave written informed consent
Exclusion criteria
Exclusion criteria: (1)Subjects who had a previous history of H5 influenza (based on the interview with the representative). (2)Subjects who had a previous history of H5 influenza vaccination (based on the interview with the representative). (3)Subjects who had evidently had anaphylaxis in the past due to foods or drugs. (4)Subjects who had a serious disease in the cardiovascular system, the hematological system, the respiratory system, the liver, the kidney or the gastrointestinal system, or a serious neuropsychiatric disease. (5)Subjects who had a previous history of Guillain-Barre syndrome or acute disseminated encephalomyelitis. (6)Subjects who had participated in other clinical study and received administration of other investigational drug within 4 months before the administration of the investigational drug, or were planning to participate in other clinical study during the study period (Day 0 to Day 201). (7)Those who received blood transfusion or the administration of gamma-globulin preparation within 3 months before the date of vaccination with the investigational drug or those who underwent high-dose (200 mg/kg or higher) gamma-globulin therapy within 6 months before the date of vaccination with the investigational drug or are going to undergo this therapy during the observation period (Day 0 to Day 42) (8)Pregnant women, women who are possibly pregnant, women who desired to get pregnant during the observation period (Day 0 to Day 42) or women who are breast-feeding. (9)In addition, subjects who were judged as being inappropriate for the subjects of this study by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy -Compliance of HI antibodies(horse RBCs) against the vaccine strain after the second administration of KD-295 (Day 42) with the Prototype Vaccine Guideline -Incidence, intensity, number of days of persistence, and number of days to the onset of solicited local adverse events (all grades and grade 3) within 7 days (from Day 0 to Day 6 and from Day 21 to Day 27) after each administration of KD-295 -Incidence, intensity, number of days of persistence, and number of days to the onset, and relationship to KD-295 administration of solicited systemic adverse events (all grades and grade 3) within 7 days (from Day 0 to Day 6 and from Day 21 to Day 27) after each administration of KD-295 -Incidence, intensity, number of days of persistence, number of days to the onset, and relationship to KD-295 administration of unsolicited adverse events after the first administration of KD-295 (Day 0) up to the post-vaccination examination day (Day 42) -Incidence and relationship to KD-295 administration of serious adverse events, pIMDs and significant adverse events during the entire study period (Day 0 to Day 201) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy The rate of at least 4-fold increase in neutralising antibody titer against the vaccine strain after the second administration of KD-295 (Day 42) | — |
Countries
Japan
Outcome results
None listed