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Phase 1b Influenza Vaccine Study in Healthy Subjects

NCT01181336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2010-10-15

No results posted yet for this study

Summary

The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response.

Conditions

Interventions

BIOLOGICAL

Influenza vaccine (FLU-v)

Comparison of different dosages of FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection of (Low Dose / High Dose with adjuvant / water for injection)

BIOLOGICAL

FLU-v Control

Adjuvant only or water for injection only Administration: a single subcutaneous injection

Sponsors & Collaborators

  • PepTcell Limited

    lead INDUSTRY

Principal Investigators

  • Stuart Robinson, Dr · PepTcell Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-07-31
Completion
2010-07-31

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 NCT01181336 on ClinicalTrials.gov