Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- PT Bio Farma
- Enrollment
- 405
- Locations
- 2
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Vaccine (Biological)
Outcomes
Primary Outcomes
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)
Time Frame: 2 months
Percentage of subjects with anti HI titer \>=1:40
Secondary Outcomes
- To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)(2 months)
- To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)(1 months)
- To asses the safety of Flubio vaccine(1-2 months)