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 range19 Years – 59 Years

SexALL

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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
✕. Those with history of influenza vaccination within the past 6 months

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