CompletedNCT03826719Updated Feb 1, 2019

Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

A Phase 1/2 interventional study of NBP607QIV and Agrippal in Influenza, sponsored by SK Chemicals Co., Ltd.. Completed. Open to participants aged 19 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by SK Chemicals Co., Ltd. · Phase 1/2, Interventional, and Prevention

From the registry’s dates

Registered 4 years 11 months after the study started (first participant enrolled Feb 2014, registered Jan 2019).

Phase: Phase 1/2
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 19 Years to 59 Years
Sex: All

Study summary

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

Read the detailed description

Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.

Conditions studied

Influenza

Browse trials for

Influenza, Human 2,214

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 100 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 59 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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
Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
Those with history of participation on another clinical trial within 1 month prior to the study vaccination
Those with history of blood donation within 1 week prior to the study vaccination or plan of blood donation within 7 days following the study vaccination
Those with any chronic diseases that interfere with the clinical trial or malignant tumors
Pregnant or breastfeeding
Those with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 100 participants (actual)

Study arms

Experimental
NBP607QIV
1 dose of 0.5mL by Intramuscular injection
Biological: NBP607QIV
Active comparator
Agrippal
1 dose of 0.5mL by Intramuscular injection
Biological: Agrippal

Interventions

BiologicalNBP607QIV
Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
BiologicalAgrippal
Influenza virus surface antigens of three strains(trivalent)

What researchers measure

Primary outcomes

Incidence rate of solicited local adverse events(AEs)
All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. Comparisons within each group between pre-/post- vaccination were summarized and presented. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Time frame: 7 days after vaccination
Incidence rate of solicited systemic AEs
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Time frame: 7 days after vaccination
Incidence rate of unsolicited AEs
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Time frame: 21 days after vaccination

Secondary outcomes

Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]
The proportion of subjects with post-vaccination HI titers of ≥1:40
Time frame: 21-28 days after vaccination
Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]
The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were \<1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer
Time frame: 21-28 days after vaccination
9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
The mean increase in geometric mean HI titer
Time frame: 21-28 days after vaccination

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03826719
Lead sponsor: SK Chemicals Co., Ltd.
Responsible party: Sponsor
First posted: Feb 1, 2019
Start date: Feb 17, 2014
Primary completion: Mar 28, 2014
Completion: Mar 28, 2014
Last update: Feb 1, 2019

Study contacts

Woo Joo Kim, MD, PhD

study chair · Korea University Guro Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Influenza, Human→

Other studies from this sponsor

SK Chemicals Co., Ltd.

Start the discussion