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Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults

NCT03658629 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1375

Last updated 2022-11-04

Study results available
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Summary

A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age.

A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

NanoFlu (Quad-NIV)

2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine

OTHER

Matrix-M Adjuvant

Adjuvant

OTHER

Placebo

Placebo

BIOLOGICAL

Fluzone HD

2018-2019 Licensed Trivalent Seasonal Influenza Vaccine

BIOLOGICAL

Flublok Quadrivalent

2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine

BIOLOGICAL

Influenza Vaccine

2018-19 Licensed Seasonal Influenza Vaccine

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2019-04-26
Completion
2019-04-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658629 on ClinicalTrials.gov