Phase 3 N=1,503 Randomized Quadruple-blind Prevention

Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT02467842 ↗

Enrolled (actual)

1,503

Serious AEs

1.0%

Results posted

May 2020

Primary outcome: Primary: Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects — 329.76; 334.98; 334.98; 401.21 titers

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: NBP607-QIV (Biological); NBP607-Y (Biological); NBP607-V (Biological)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: SK Chemicals Co., Ltd.
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects	329.76; 334.98; 334.98; 401.21; 377.34; 377.34	—
PRIMARY Seroconversion Rate (SCR) After Vaccination in All Subjects	52.41; 52.56; 50.27; 51.20; 46.09; 46.28	—
PRIMARY Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years	92.76; 98.68; 94.08; 96.05	—
PRIMARY Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years	52.63; 42.11; 43.42; 59.87	—
PRIMARY Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years	4.07; 3.27; 2.99; 4.61	—
SECONDARY Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects	163.74; 144.65; 123.08; 124.82; 93.29; 112.20	—
SECONDARY Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects	43.72; 36.66; 24.73; 55.75; 43.13; 52.66	—
SECONDARY Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years	98.32; 99.50; 98.49; 99.16	—
SECONDARY Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years	52.35; 53.52; 43.79; 54.70	—
SECONDARY Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years	4.83; 3.80; 3.21; 4.08	—

Summary

All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination.

Eligibility Criteria

Inclusion Criteria

Adults aged 19 years and older
Those who are able to comply with the requirements for the study
If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration

Exclusion Criteria

Disorders in immune function
Any malignancy or lymphoproliferative disorder
History of Guillain-Barré syndrome
Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
Experience of fever (>38.0 ℃) within 24 hours following vaccination
Body temperature >38.0 ℃ at the vaccination day
Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3 months
Influenza vaccination within 6 months
Subjects who have participated in other interventional study within 4 weeks
Any vaccination within 1 month
Those who are planning to receive any vaccine within 1 month from the study vaccine
Individuals with any serious chronic or progressive disease
Pregnant or breast-feeding women
Any other reason that in the opinion of the investigator might interfere with the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02467842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.