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Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP

NCT03722589 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 944

Last updated 2024-07-22

Study results available
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Summary

This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64 years. The trial will be conducted at two sites in the United States during two influenza seasons (2018-19 and 2019-20). Stratified enrollment procedures will be used to enroll a mix of participants based on age.

Conditions

Interventions

BIOLOGICAL

Flublok

0.5 mL intramuscular dose of Flublok

BIOLOGICAL

Flucelvax

0.5 mL intramuscular dose of Flucelvax

BIOLOGICAL

Fluarix

0.5 mL intramuscular dose of Fluarix

BIOLOGICAL

Fluzone

0.5 mL intramuscular dose of Fluzone

BIOLOGICAL

Fluzone High-Dose

0.5 mL intramuscular dose of Fluzone

Sponsors & Collaborators

Principal Investigators

  • Fatimah Dawood, MD · Centers for Disease Control and Prevention

  • Brendan Flannery, PhD · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-12
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03722589 on ClinicalTrials.gov