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Safety and Immunogenicity of Different Formulations of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects 65 Years of Age and Above

NCT02126761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2016-07-29

No results posted yet for this study

Summary

In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of age.

Conditions

Interventions

BIOLOGICAL

Adjuvanted, trivalent subunit influenza vaccine

Group 1 and group 5 are active comparators; group 5 includes placebo comparator as a second injection in contralateral deltoid

BIOLOGICAL

Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Group 2 and group 6 are experimental; group 2 has double dosage of MF59 in a single injection; group 6 has triple dosage of MF59 and includes placebo comparator in contralateral deltoid

BIOLOGICAL

Antigen level modified adjuvanted, trivalent subunit influenza vaccine

Group 3 is experimental with double the usual antigen dosage

BIOLOGICAL

Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Group 4 and 7 are experimental; group 4 has one injection with double the antigen and adjuvant; group 7 has two injections with double the antigen and adjuvant

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Germany

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 NCT02126761 on ClinicalTrials.gov