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Improved Novel VaccIne CombinaTion InflUenza Study

NCT03300362 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 862

Last updated 2018-11-23

No results posted yet for this study

Summary

A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and efficacy of the co-administration of a viral vectored vaccine, MVA- NP+M1, and the annual recommended licensed inactivated influenza vaccine (IIV). Within the main cohort 100 participants will be recruited to an immunology sub-cohort.

Conditions

Interventions

DRUG

Seasonal influenza vaccine

Seasonal influenza vaccine

DRUG

MVA-NP+M1

Trial vaccine

DRUG

Sodium chloride

Saline placebo

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Barinthus Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • Christopher Butler · University of Sussex

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03300362 on ClinicalTrials.gov