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Completed

NCT Number: NCT03336593

Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population

Completed

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Key information

Conditions

Age range

6 month–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Garuda Primary Health Center, Bandung, West Java, Indonesia

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About this study

To describe the protectivity rate of Quadrivalent Influenza HA vaccine 28 days after immunization in Indonesian population.

To describe immunogenicity of quadrivalent Influenza HA vaccine in all subjects

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for Subjects 9 - 40 Years of Age:

  • Healthy
  • Properly informed about the study and having signed the informed consent form
  • Subject/Parent will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Inclusion criteria

for Subjects 6 Months - 8 Years of Age:

  • 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

  • Subject concomitantly enrolled or scheduled to be enrolled in another trial
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >= 37.5 C )
  • Known history of allergy to egg and or chicken protein or any component of the vaccines
  • History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
  • Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
  • Pregnancy & Lactation (Adult)
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
  • Subject already immunized with influenza vaccine within 1 year.
  • Subjects receive any vaccination within 1 month before and after immunization of Quadrivalent Influenza Vaccine.

Treatment and study plan

Quadrivalent Influenza Vaccine

Biological

1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

Other names: QIV

Trivalent Influenza Vaccine

Biological

1 dose of Trivalent Influenza Vaccine

Other names: TIV

Primary outcomes

  1. Percentage of subjects with an anti-influenza titer >= 1:40 HI units

    Time frame: 28 days after the last dose immunization

    The anti-influenza antibody serological response

Secondary outcomes

  1. Geometric Mean Titer (GMT)

    Time frame: 28 days

    GMT in all subjects; comparison of GMT between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison of GMT between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old

  2. Percentage of subjects with increasing antibody titer >= 4 times

    Time frame: 28 days

    Percentage of subjects with increasing antibody titer >= 4 times: in all subjects; comparison between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old

  3. Percentage of subjects with transition of seronegative to seropositive

    Time frame: 28 days

    Percentage of subjects with transition of seronegative to seropositive: in all subjects; comparison between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old

  4. Percentage of subjects with at least one immediate reaction

    Time frame: 30 minutes after each vaccination

    Immediate reaction (local reaction or systemic event)

  5. Percentage of subjects with at least one of these adverse events

    Time frame: within 72 hours, between 72 hours to 28 days after vaccination

    At least one of these adverse events, expected or not

  6. Serious adverse event after vaccination

    Time frame: 28 days

    Serious adverse event occurring from inclusion until 28 days after vaccination.

  7. Comparison adverse events between quadrivalent and trivalent influenza HA vaccine.

    Time frame: 28 days

    Adverse events occuring until 28 days after vaccination

  8. Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine.

    Time frame: 28 days

    Adverse events occuring until 28 days after vaccination

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Official study title

A Bridging Study to Assess Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2017
Registry last updated
Apr 2, 2019

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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