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

May 28, 2019 updated by: Novartis Vaccines

A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1561

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States
        • Anaheim Clincial Trials
      • Redding, California, United States
        • Northern California Clinical Research Center
      • San Diego, California, United States
        • Southern California CRC
    • Florida
      • Hollywood, Florida, United States
        • Broward Research Group
      • West Palm Beach, Florida, United States
        • Comprehensive Clinical Trials, Llc
      • West Palm Beach, Florida, United States
        • Palm Bech Research
    • Georgia
      • Savannah, Georgia, United States
        • Meridian Clinical Research
    • Kansas
      • Lenexa, Kansas, United States
        • Johnson County Clin-Trials, LLC
      • Wichita, Kansas, United States
        • Heartland Research Associates, LLC
    • Massachusetts
      • Milford, Massachusetts, United States
        • Milford Emergency Associate,Inc
    • Nebraska
      • Omaha, Nebraska, United States
        • Meridian Clinical Research
    • New York
      • Rochester, New York, United States
        • Rochester Clinical Research, Inc
    • North Carolina
      • Charlotte, North Carolina, United States
        • PMG Research of Charlotte
      • Hickory, North Carolina, United States
        • PMG Research of Hickory
      • Raleigh, North Carolina, United States
        • PMG Research of Raleigh
    • Ohio
      • Cincinnati, Ohio, United States
        • New Horizons Clinical Research
    • Oregon
      • Portland, Oregon, United States
        • Columbia Research Group, Inc
    • Rhode Island
      • Warwick, Rhode Island, United States
        • Omega Medical Research
    • Tennessee
      • Franklin, Tennessee, United States
        • Clinical Research Solutions, LLC
      • Nashville, Tennessee, United States
        • Clinical Research Associates, Inc
    • Utah
      • Salt Lake City, Utah, United States
        • Foothill Family Clinc South, J. Lewis Research Inc.
      • Salt Lake City, Utah, United States
        • Foothill Family Clinic, J. Lewis Research Inc.
      • South Jordan, Utah, United States
        • Jordan River Family Medicine, J. Lewis Research, Inc.
    • Virginia
      • Norfolk, Virginia, United States
        • Clinical Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females 18 through 49 years of age.
  • Subjects having provided informed consent.
  • Individuals in good health

Exclusion Criteria:

  • Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
  • Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVc-Lot A
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
Biological: TIVc_LOT A
Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
Experimental: TIVc-Lot B
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
Biological: TIVc_LOT B
Single IM administration dose of 0.5 mL of TIVc
Experimental: TIVc-Lot C
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
Biological: TIVc_LOT C
Single IM administration dose of 0.5 mL of TIVc
Active Comparator: TIVf
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
Biological: TIVf
Single IM administration dose of 0.5 mL of TIVf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
Time Frame: Day 22
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
Day 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
Time Frame: Day 22

Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).

Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.

HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.

According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.
Day 22
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Time Frame: Day 1 through day 7 (without 30 min)
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.
Day 1 through day 7 (without 30 min)
Number of Subjects With Unsolicited Adverse Events
Time Frame: Day 1 through day 22
Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.
Day 1 through day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V58_23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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