Clinical trial NCT02093260: Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Official title: Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy
Keywords: Flubio Vaccine (Influenza HA)
Infants
Children
Safety
Immunogenicity
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 405
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 2 months
Secondary outcomes:
measure: To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)
timeFrame: 2 months
measure: To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)
timeFrame: 1 months
measure: To asses the safety of Flubio vaccine
timeFrame: 1-2 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Jatinegara Primary Health Center
city: Jakarta
country: Indonesia
facility: Primary School of SDN 01 Kampung Melayu
Study officials:
affiliation: Department of Child Health, School of Medicine, University of Indonesia
name: Bernie Endyarni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soedjatmiko S, Medise BE, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Bachtiar NS, Sari RM. Immunogenicity and safety of a Trivalent Influenza HA vaccine in Indonesian infants and children. Vaccine. 2018 Apr 12;36(16):2126-2132. doi: 10.1016/j.vaccine.2018.02.114. Epub 2018 Mar 16.