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A Study to Evaluate Safety and Immunogenicity of Trivalent Influenza Vaccine, Formulation 2015 Southern Hemisphere, When Administered to Healthy Adult Subjects.

NCT02427750 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2015-10-19

Study results available
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Summary

The present study is designed to evaluate the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.

For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post vaccination.

The vaccine composition will be based on the WHO recommended influenza strains for the 2015 Southern Hemisphere vaccine, and the data from this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same.

Conditions

  • Human Influenza

Interventions

BIOLOGICAL

Aggripal®

TIV

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT02427750 on ClinicalTrials.gov