Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

PT Bio Farma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy

Treatments: Biological: Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02093260

Influenza 0213

Details and patient eligibility

About

To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

Full 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.

Enrollment: 405 patients

Sex: All

Ages: 6 months to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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405 participants in 1 patient group

Vaccine

Experimental group

Description:

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

Treatment:

Biological: Vaccine