Phase 3
Completed N=1,503
Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects
Source: ClinicalTrials.gov NCT02467842 ↗Enrolled (actual)
1,503
Serious AEs
1.0%
Results posted
May 2020
Primary outcomePrimary: Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects — 329.76; 334.98; 334.98; 401.21 titers
◆ Published Evidence
Emerging
10citations · ~1 / year
Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects.
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.
Linked Publications
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Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT02467842) and the linked publication. 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. Informational only — not medical advice.