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Safety IssuesPhase 2NCT03336593

Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

A Phase 2 study testing Quadrivalent Influenza Vaccine and Trivalent Influenza Vaccine in people with Safety Issues, run by PT Bio Farma at 3 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population Read more about this study

Who is it for?
Ages 6 months to 40 yearsHealthy volunteers can take part
Conditions the study is for
Safety Issues
What is being tested?
Quadrivalent Influenza Vaccine and Trivalent Influenza Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
810 participants
Where
3 sitesIndonesia
Study dates
21 Nov 2017to 30 Nov 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Indonesia3 sites

  • Garuda Primary Health Center

    Bandung, West Java

  • Ibrahim Adjie Primary Health Center

    Bandung, West Java

  • Puter Primary Health Center

    Bandung, West Java

Other trials in Indonesia

About this study

Official title: A Bridging Study to Assess 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

Read the 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

Conditions
Safety Issues
Being tested
Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadrivalent Influenza VaccineBiological

    Also called QIV

    1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

  • Trivalent Influenza VaccineBiological

    Also called TIV

    1 dose of Trivalent Influenza Vaccine

Study groups in NCT03336593
Study groupRoleWhat they receive
QIV batch 1Experimental1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1
Receives: Biological: Quadrivalent Influenza Vaccine
QIV batch 2Experimental1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2
Receives: Biological: Quadrivalent Influenza Vaccine
QIV batch 3Experimental1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3
Receives: Biological: Quadrivalent Influenza Vaccine
Trivalent Influenza VaccineActive comparator1 dose of 0.5 ml of trivalent influenza vaccine
Receives: Biological: Trivalent Influenza Vaccine
QIV (subjects 6-35 months)Experimental2 dose of 0.25 ml of quadrivalent influenza vaccine
Receives: Biological: Quadrivalent Influenza Vaccine
QIV (subjects 3-8 years)Experimental2 dose of 0.5 ml of quadrivalent influenza vaccine
Receives: Biological: Quadrivalent Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The anti-influenza antibody serological response

    Measured: 28 days after the last dose immunization

Secondary outcomes (8)

  1. Geometric Mean Titer (GMT)

    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

    Measured: 28 days

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

    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

    Measured: 28 days

  3. Percentage of subjects with transition of seronegative to seropositive

    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

    Measured: 28 days

  4. Percentage of subjects with at least one immediate reaction

    Immediate reaction (local reaction or systemic event)

    Measured: 30 minutes after each vaccination

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

    At least one of these adverse events, expected or not

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

  6. Serious adverse event after vaccination

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

    Measured: 28 days

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

    Adverse events occuring until 28 days after vaccination

    Measured: 28 days

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

    Adverse events occuring until 28 days after vaccination

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start21 Nov 2017
  3. Primary completion14 Mar 2018
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
810 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03336593
Sponsor's protocol ID
QIV 0217
Status last verified
Apr 2019
First submitted
6 Nov 2017
Last updated
2 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37616221

  • 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.

    PubMed 31862195

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quadrivalent Influenza Vaccine and Trivalent Influenza Vaccine in people with Safety Issues, run by PT Bio Farma at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with an anti-influenza titer >= 1:40 HI units (time frame: 28 days after the last dose immunization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03336593, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.

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