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

Healthy Clinical Trial

Official title:

Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093260
• Other study ID #: Influenza 0213
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 19, 2014
• Last updated: April 27, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• 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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Indonesia	Jatinegara Primary Health Center	Jakarta
Indonesia	Primary School of SDN 01 Kampung Melayu	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

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