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Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine

NCT02107807 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 539

Last updated 2016-05-09

No results posted yet for this study

Summary

Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without immunosuppressive conditions.

Conditions

  • Influenza, Human
  • Flu, Human
  • Flu, Avian
  • Influenza
  • Influenza A Virus, H5N1 Subtype

Interventions

BIOLOGICAL

Novartis Investigational H5N1 vaccine

2 doses of 0.5 ml, 3 weeks apart

BIOLOGICAL

Novartis Investigational H5N1 vaccine

2 doses of 0.5 ml, 3 weeks apart

BIOLOGICAL

Novartis Seasonal Influenza Vaccine

2 doses of 0.5 ml, 3 weeks apart

BIOLOGICAL

Novartis Seasonal Influenza Vaccine

2 doses of 0.5 ml, 3 weeks apart

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Australia
  • Germany
  • Italy

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 NCT02107807 on ClinicalTrials.gov