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

NCT02093260 | Completed Phase 2

• 1 other identifier: Influenza 0213
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

Flubio Vaccine (Influenza HA); Infants; Children; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

Vaccine

EXPERIMENTAL

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

Biological: Vaccine

Interventions

Vaccine BIOLOGICAL

Flubio (Influenza HA) Vaccine The vaccine will be given intramuscularly.

Also known as: Flubio

Vaccine

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (2)

Jatinegara Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Primary School of SDN 01 Kampung Melayu

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 29551225 DERIVED

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Bernie Endyarni, MD

  Department of Child Health, School of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 20, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

ID (2)