Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

NCT03336593 | Completed Phase 2

• 1 other identifier: QIV 0217
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

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

  The anti-influenza antibody serological response

  28 days after the last dose immunization

Secondary Outcomes (8)

• Geometric Mean Titer (GMT)

  28 days

• Percentage of subjects with increasing antibody titer >= 4 times

  28 days

• Percentage of subjects with transition of seronegative to seropositive

  28 days

• Percentage of subjects with at least one immediate reaction

  30 minutes after each vaccination

• Percentage of subjects with at least one of these adverse events

  within 72 hours, between 72 hours to 28 days after vaccination

Study Arms (6)

QIV batch 1

EXPERIMENTAL

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1

Biological: Quadrivalent Influenza Vaccine

QIV batch 2

EXPERIMENTAL

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2

Biological: Quadrivalent Influenza Vaccine

QIV batch 3

EXPERIMENTAL

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3

Biological: Quadrivalent Influenza Vaccine

Trivalent Influenza Vaccine

ACTIVE COMPARATOR

1 dose of 0.5 ml of trivalent influenza vaccine

Biological: Trivalent Influenza Vaccine

QIV (subjects 6-35 months)

EXPERIMENTAL

2 dose of 0.25 ml of quadrivalent influenza vaccine

Biological: Quadrivalent Influenza Vaccine

QIV (subjects 3-8 years)

EXPERIMENTAL

2 dose of 0.5 ml of quadrivalent influenza vaccine

Biological: Quadrivalent Influenza Vaccine

Interventions

Quadrivalent Influenza Vaccine BIOLOGICAL

1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

Also known as: QIV

QIV (subjects 3-8 years); QIV (subjects 6-35 months); QIV batch 1; QIV batch 2; QIV batch 3

Trivalent Influenza Vaccine BIOLOGICAL

1 dose of Trivalent Influenza Vaccine

Also known as: TIV

Trivalent Influenza Vaccine

Eligibility Criteria

• Age: 6 Months - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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:

• 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.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (3)

Garuda Primary Health Center

Bandung, West Java, Indonesia

Location

Ibrahim Adjie Primary Health Center

Bandung, West Java, Indonesia

Location

Puter Primary Health Center

Bandung, West Java, Indonesia

Location

Related Publications (2)

• Fadlyana E, Dhamayanti M, Tarigan R, Prodjosoewojo S, Rahmadi AR, Sari RM, Rusmil K, Kartasasmita CB. Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults. PLoS One. 2023 Aug 24;18(8):e0281566. doi: 10.1371/journal.pone.0281566. eCollection 2023.

  PMID: 37616221 DERIVED

• 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.

  PMID: 31862195 DERIVED

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Meita Dhamayanti

  Hasan Sadikin General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study for subjects 9-40 years of age is randomized, double blind study. While the study for subjects 6 months-8 years of age is open labeled study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects 9- 40 years of age: Experimental, randomized, double blind bridging study Subjects 6 months - 8 years of age: Experimental, open labeled bridging study

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: November 21, 2017
• Primary Completion: March 14, 2018
• Study Completion: November 30, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-04

Locations

ID (3)