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A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2

NCT01596725 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2014-02-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.

Conditions

  • Influenza (Pandemic)

Interventions

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1)

Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1)

Dose B without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1); Adjuvant

Dose B with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1); Adjuvant

Dose C with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21

BIOLOGICAL

Monovalent Avian Influenza VLP (H5N1); Adjuvant

Dose D with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21

BIOLOGICAL

Saline Placebo

Placebo; intramuscular, deltoid, Day 0 and Day 21

Sponsors & Collaborators

Principal Investigators

  • Nigel Thomas, Ph.D · Novavax

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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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 NCT01596725 on ClinicalTrials.gov