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Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine

NCT01072799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4560

Last updated 2012-04-25

No results posted yet for this study

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of age).

Conditions

Interventions

BIOLOGICAL

Placebo

Two doses (Day 1 and Day 22); 0.5mL

BIOLOGICAL

A/H1N1 2009 Influenza VLP Vaccine

Two doses (Day 1 \& Day 22); 0.5mL

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Constantino R Lopez Macias, M.D. · Specialities Hospital, National Medical Centre "Siglo XXI" Mexican Institute for Social Security (IMSS)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Mexico

Study Locations

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Entities

Drugs
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 NCT01072799 on ClinicalTrials.gov