MedTrace Logo

Dose, Safety, and Pathogenicity of a New Influenza H1N1 Challenge Strain

NCT05572450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-09-13

No results posted yet for this study

Summary

A total of up to 90 participants may be given H1N1 influenza challenge virus.

In Part A, 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2).

Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose 2, or another virus dose (e.g., Virus Dose 3)

Conditions

  • Influenza A H1N1

Interventions

OTHER

Infectious Titre 1

Approximately 10\^5.5 TCID50/mL (titre may be adjusted based on stock titre)

OTHER

Infectious Titre 2

Approximately 10\^4.5 TCID50/mL (titre may be adjusted based on stock titre)

OTHER

Infectious Titre 3

To be determined (TBD), depending on outcome of Part A

OTHER

Infectious Titre 4

TBD, depending on outcome of Part A

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hvivo

    lead INDUSTRY

Principal Investigators

  • Alex Mann · hVIVO Services Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2022-12-19
Completion
2022-12-19

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 NCT05572450 on ClinicalTrials.gov