CompletedPhase 1/2

Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

100 participantsStarted 2014-02-17

Plain-language summary

This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.

Who can participate

Age range

19 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy adults aged 19 to 59 years
. Those who are able and willing to give written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study
. If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Exclusion criteria

. Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
. Those with Immunodeficiency disease
. Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
. Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
. Those who experienced fever (\>38°C) within the past 24 hours or any acute respiratory infection
. Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
. Those with history of receiving blood products or immunoglobulin within the past 3 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence rate of solicited local adverse events(AEs)

Timeframe: 7 days after vaccination

Incidence rate of solicited systemic AEs

Timeframe: 7 days after vaccination

Incidence rate of unsolicited AEs

Timeframe: 21 days after vaccination

Trial details

NCT IDNCT03826719

SponsorSK Chemicals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03-28

View on ClinicalTrials.gov More Influenza trials