MedTrace Logo

Dose, Safety, and Pathogenicity of a New Influenza B Strain

NCT06254820 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-12

No results posted yet for this study

Summary

This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age.

Conditions

  • Influenza B

Interventions

BIOLOGICAL

influenza B/Connecticut/1/21 virus part a dose arm 1

Medium dose, expected to be approximately 10\^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)

BIOLOGICAL

influenza B/Connecticut/1/21 virus part a dose arm 2

High dose, expected to be approximately 10\^7 TCID50/ mL (titer may be adjusted based on stock titer)

BIOLOGICAL

influenza B/Connecticut/1/21 virus part b dose 1

Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR Dose Arm 3

BIOLOGICAL

influenza B/Connecticut/1/21 virus part b dose 2

Addition of a 3rd dose, TBD depending on outcome of Part A

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hvivo

    lead INDUSTRY

Principal Investigators

  • Victoria Parker, MBBS · hVIVO Services Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2024-02-02
Completion
2024-02-08

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT06254820 on ClinicalTrials.gov