Randomized Influenza Vaccine Evaluation of Immune Response

Influenza Clinical Trial

— RIVER  

Official title:

Randomized Open-Label Trial to Compare Immunogenicity of Egg-Based and Non-Egg Based Quadrivalent Influenza Vaccines Among Adults 18-64 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2018-19 and 2019-20)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03598439
• Other study ID #: MCL10218
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 30, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Marshfield Clinic Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Licensed influenza vaccines are manufactured with a variety of technologies. The majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and FluBlok (recombinant). There is increasing evidence that egg propagation induces virus mutations that impair the immune responses to circulating viruses. However, the impact of egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential recommendation for any specific influenza vaccine product or technology. A direct comparison of serologic response to egg based and non-egg based vaccines in adults has not been performed. This randomized trial will compare serologic responses to the egg- and non-egg A(H3N2) vaccine component. The study cohort will be followed for two influenza seasons to evaluate sequential vaccination effects on immune response.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 366
• Est. completion date: December 30, 2023
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Aged 18-64 years

• Marshfield Clinic patients living in or around Marshfield, Wisconsin since July 2015

• Willing and able to give informed consent and comply with study requirements

Exclusion Criteria:

• Receipt of 2018-19 influenza vaccine prior to study enrollment

• Known to be pregnant at the time of enrollment

• Current participation or plans to participate in another clinical trial involving an experimental agent

• Presence of a contraindication to influenza vaccination

• Plans to relocate outside the geographic location in the next two years

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Standard IIV4
Standard inactivated influenza vaccine
• Recombinant
Influenza vaccine that uses a hemagglutinin protein manufactured in insect cells with a baculovirus vector
• Cell-culture
inactivated influenza vaccine manufactured using mammalian cell lines; current vaccine uses a cell-propagated H3N2 strain.

Locations

Country	Name	City	State
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Marshfield Clinic Research Foundation	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-vaccination titer	geometric mean titers (as measured by microneutralization) to cell-grown A(H3N2) vaccine reference virus	28 days