Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Phase 2
Completed
- Conditions
- Healthy
- Interventions
- Biological: Vaccine
- Registration Number
- NCT02093260
- Lead Sponsor
- PT Bio Farma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaccine Vaccine Vaccine Flubio (Influenza HA) vaccine 2 doses for infants and children (6 months - 8 years old) 1 doses for children (9-11 years old) The vaccine will be given intramuscularly
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Jatinegara Primary Health Center
🇮🇩Jakarta, Indonesia
Primary School of SDN 01 Kampung Melayu
🇮🇩Jakarta, Indonesia