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Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

NCT02256488 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1561

Last updated 2019-06-11

Study results available
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Summary

The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).

The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.

The total study participation time per subject is about 3 weeks.

Conditions

  • Prophylaxis: Influenza

Interventions

BIOLOGICAL

TIVc_LOT A

Single IM (Intramuscular) administration dose of 0.5 mL of TIVc

BIOLOGICAL

TIVc_LOT B

Single IM administration dose of 0.5 mL of TIVc

BIOLOGICAL

TIVc_LOT C

Single IM administration dose of 0.5 mL of TIVc

BIOLOGICAL

TIVf

Single IM administration dose of 0.5 mL of TIVf

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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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 NCT02256488 on ClinicalTrials.gov