Healthy
Conditions
Keywords
Flubio Vaccine (Influenza HA), Infants, Children, Safety, Immunogenicity
Brief summary
To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Detailed description
Too see percentage of subjects with HI titer \>= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
Interventions
BIOLOGICALVaccine
Flubio (Influenza HA) Vaccine The vaccine will be given intramuscularly.
Sponsors
PT Bio Farma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Parents have been informed properly regarding the study and signed the informed consent form * Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial
Exclusion criteria
* Subjects concomitantly enrolled or scheduled to be enrolled in another trial * Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature \>=37oC) * Known history of allergy to egg and/or chicken protein or any other component of the vaccines * Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection * Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\>2 weeks)). * Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives. * Subjects has been immunized with influenza vaccine within 1 year * Subjects receives any vaccination within 1 months before and after immunization of Flubio.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age) | 2 months | Percentage of subjects with anti HI titer \>=1:40 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old) | 2 months | Percentage subjects with increasing antibody titer \>=4 times |
| To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old) | 1 months | Percentage of subjects with transition of seronegative to seropositive |
| To asses the safety of Flubio vaccine | 1-2 months | Local and Systemic Reaction following immunization |
Countries
Indonesia
Outcome results
None listed