Healthy Clinical Trial
Official title:
Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children
Verified date | April 2015 |
Source | PT Bio Farma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Status | Completed |
Enrollment | 405 |
Est. completion date | December 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 11 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Indonesia | Jatinegara Primary Health Center | Jakarta | |
Indonesia | Primary School of SDN 01 Kampung Melayu | Jakarta |
Lead Sponsor | Collaborator |
---|---|
PT Bio Farma |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Percentage of subjects with anti HI titer >=1:40 | 2 months | No |
Secondary | To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old) | Percentage subjects with increasing antibody titer >=4 times | 2 months | No |
Secondary | To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old) | Percentage of subjects with transition of seronegative to seropositive | 1 months | No |
Secondary | To asses the safety of Flubio vaccine | Local and Systemic Reaction following immunization | 1-2 months | Yes |
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