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Completed

NCT Number: NCT02093260

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

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

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Key information

Conditions

Healthy

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Jatinegara Primary Health Center, Jakarta, Jakarta Special Capital Region, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaccine

Biological

Flubio (Influenza HA) Vaccine

The vaccine will be given intramuscularly.

Other names: Flubio

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)

    Time frame: 2 months

    Percentage of subjects with anti HI titer >=1:40

Secondary outcomes

  1. To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)

    Time frame: 2 months

    Percentage subjects with increasing antibody titer >=4 times

  2. To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)

    Time frame: 1 months

    Percentage of subjects with transition of seronegative to seropositive

  3. To asses the safety of Flubio vaccine

    Time frame: 1-2 months

    Local and Systemic Reaction following immunization

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2014
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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