Clinical trial NCT03336593: Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
Official title: A Bridging Study to Assess Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Safety Issues
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2017-11-08
Enrollment: 810
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects 9- 40 years of age: Experimental, randomized, double blind bridging study Subjects 6 months - 8 years of age: Experimental, open labeled bridging study
Primary purpose: PREVENTION

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

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of subjects with an anti-influenza titer >= 1:40 HI units
timeFrame: 28 days after the last dose immunization
Secondary outcomes:
measure: Geometric Mean Titer (GMT)
timeFrame: 28 days
measure: Percentage of subjects with increasing antibody titer >= 4 times
timeFrame: 28 days
measure: Percentage of subjects with transition of seronegative to seropositive
timeFrame: 28 days
measure: Percentage of subjects with at least one immediate reaction
timeFrame: 30 minutes after each vaccination
measure: Percentage of subjects with at least one of these adverse events
timeFrame: within 72 hours, between 72 hours to 28 days after vaccination
measure: Serious adverse event after vaccination
timeFrame: 28 days
measure: Comparison adverse events between quadrivalent and trivalent influenza HA vaccine.
timeFrame: 28 days
measure: Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine.
timeFrame: 28 days
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Garuda Primary Health Center
state: West Java
city: Bandung
country: Indonesia
facility: Ibrahim Adjie Primary Health Center
state: West Java
city: Bandung
country: Indonesia
facility: Puter Primary Health Center
state: West Java
Study officials:
affiliation: Hasan Sadikin General Hospital
name: Meita Dhamayanti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhamayanti M, Tarigan R, Fadlyana E, Prasetyo D, Amalia N, Rusmil VK, Sari RM, Bachtiar NS, Rusmil K, Kartasasmita CB. Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study. Vaccine. 2020 Jan 29;38(5):993-1000. doi: 10.1016/j.vaccine.2019.12.008. Epub 2019 Dec 17.