Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

NCT ID: NCT01992094

Last Updated: 2015-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-07-31

Brief Summary

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Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza Influenza vaccine Novartis Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QIVc

Influenza vaccine

Group Type EXPERIMENTAL

QIVc

Intervention Type BIOLOGICAL

Novartis Investigational Quadrivalent Vaccine

TIV1c

Influenza vaccine

Group Type ACTIVE_COMPARATOR

TIV1c

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine

TIV2c

Influenza vaccine

Group Type ACTIVE_COMPARATOR

TIV2c

Intervention Type BIOLOGICAL

Novartis Investigational Vaccine

Interventions

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QIVc

Novartis Investigational Quadrivalent Vaccine

Intervention Type BIOLOGICAL

TIV1c

Licensed Influenza Vaccine

Intervention Type BIOLOGICAL

TIV2c

Novartis Investigational Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Male or female ages 18 years and older.
2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up.

Exclusion Criteria

1. Individuals recently vaccinated against influenza
2. Subjects with contraindications to receive influenza vaccine
3. Please contact the site for additional eligibility criteria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Huntsville, Alabama, United States

Site Status

Phoenix, Arizona, United States

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Anaheim, California, United States

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San Diego, California, United States

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Coral Gables, Florida, United States

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Hollywood, Florida, United States

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Melbourne, Florida, United States

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South Miami, Florida, United States

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West Palm Beach, Florida, United States

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Peoria, Illinois, United States

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Mishawaka, Indiana, United States

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Council Bluffs, Iowa, United States

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Newton, Kansas, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Metairie, Louisiana, United States

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Rockville, Maryland, United States

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Edina, Minnesota, United States

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Bellevue, Nebraska, United States

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Omaha, Nebraska, United States

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Endwell, New York, United States

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Rochester, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Dakota Dunes, South Dakota, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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San Angelo, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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South Jordan, Utah, United States

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Countries

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United States

Other Identifiers

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V130_01

Identifier Type: -

Identifier Source: org_study_id