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A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1

NCT01897701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2014-10-13

No results posted yet for this study

Summary

This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups.

Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.

Conditions

  • Avian Influenza

Interventions

BIOLOGICAL

Monovalent Avian Influenza VLP (H7N9)

BIOLOGICAL

Adjuvant 1

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • D. Nigel Thomas, Ph.D. · Novavax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT01897701 on ClinicalTrials.gov