Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)

NCT ID: NCT01773928

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1928 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process:

1. induces immune responses comparable to that produced by the current manufacturing process

2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine

3. demonstrates consistency of immune response among three different lots.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

VCIV - Modified manufacturing process (18-49 Years Old) Lot 1

Vero cell-derived trivalent influenza vaccine (VCIV)

Group Type: EXPERIMENTAL

Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

Intervention Type: BIOLOGICAL

VCIV - Modified manufacturing process (18-49 Years Old) Lot 2

Vero cell-derived trivalent influenza vaccine (VCIV)

Group Type: EXPERIMENTAL

Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

Intervention Type: BIOLOGICAL

VCIV - Modified manufacturing process (18-49 Years Old) Lot 3

Vero cell-derived trivalent influenza vaccine (VCIV)

Group Type: EXPERIMENTAL

Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

Intervention Type: BIOLOGICAL

VCIV manufactured with current process (18-49 Years Old)

Vero cell-derived trivalent influenza vaccine (VCIV)

Group Type: ACTIVE_COMPARATOR

VCIV manufactured with the current manufacturing process (VCIV current)

Intervention Type: BIOLOGICAL

Fluzone® (18-49 Years Old)

Fluzone®, licensed trivalent influenza vaccine (TIV)

Group Type: ACTIVE_COMPARATOR

Fluzone®, licensed trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

VCIV - Modified manufacturing process (≥50 Years Old) Lot 1

Vero cell-derived trivalent influenza vaccine (VCIV)

Group Type: EXPERIMENTAL

Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

Intervention Type: BIOLOGICAL

VCIV - Modified manufacturing process (≥50 Years Old) Lot 2

Vero cell-derived trivalent influenza vaccine (VCIV)

Group Type: EXPERIMENTAL

Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

Intervention Type: BIOLOGICAL

VCIV - Modified manufacturing process (≥50 Years Old) Lot 3

Vero cell-derived trivalent influenza vaccine (VCIV)

Group Type: EXPERIMENTAL

Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

Intervention Type: BIOLOGICAL

Fluzone® (≥50 Years Old)

Fluzone®, licensed trivalent influenza vaccine (TIV)

Group Type: ACTIVE_COMPARATOR

Fluzone®, licensed trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

Interventions

Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

Intervention Type: BIOLOGICAL

VCIV manufactured with the current manufacturing process (VCIV current)

Intervention Type: BIOLOGICAL

Fluzone®, licensed trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Participant is 18 to 49 years of age, inclusive, at the time of screening (for Cohort 18 to 49 years of age);
• Participant is 50 years of age, inclusive, or older at the time of screening (for Cohort 50 years of age or older);
• Participant gave written informed consent prior to study entry
• Participant is generally healthy without any significant medical risk conditions, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination;
• Participant is willing and able to comply with the requirements of the protocol;
• Participant agrees to keep a record of symptoms for the duration of the study;
• If female and capable of bearing children - participant has a negative urine pregnancy test at the study site, within 36 hours prior to vaccination, and agrees to employ adequate birth control measures for the duration of the study. For the purposes of this study adequate birth control measures incorporate one of the following FDA approved birth control measures for the duration of the study:

• Hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR
• A barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).

Exclusion Criteria

• Participant has been vaccinated with seasonal trivalent influenza vaccine in the current season;
• Participant has an oral temperature of ≥100.4°F (≥38.0°C) on the day of vaccination in this study;
• Participant has received a live vaccine within 4 weeks, or an inactivated or subunit vaccine within 2 weeks of study entry;
• Participant with a known history of infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAgs) or Hepatitis C Virus (HCV);
• Participant has any medically diagnosed or suspected immune deficient condition based on medical history and physical examination as determined by the Investigator;
• Participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled corticosteroids (> 800 μg/day of beclomethasone dipropionate or equivalent), radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be permitted);
• Participant has a known history of Guillain Barré Syndrome, demyelinating disorders (including acute demyelinating encephalomyelitis (ADEM), Multiple Sclerosis) or convulsions;
• Participant has a history of severe allergic reactions or anaphylaxis as determined by the Investigator;
• Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating as determined by the Investigator;
• Participant has received any blood products (e.g. blood transfusion or immunoglobulins) within 90 days prior to study entry;
• Participant has donated one or more units of blood (approximately 450 mL) or plasma within 30 days prior to study entry;
• Participant has a functional or surgical asplenia;
• Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
• Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the Investigator or study site personnel conducting the study;
• If female, participant is pregnant or lactating at the time of study enrollment;
• Participant is currently enrolled or has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to study enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study;
• Participant has any condition that in the opinion of the Investigator would interfere with evaluation of the vaccine or interpretation of study results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nirjhar Chatterjee, MD

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

East Valley Family Physicians, PLC

Chandler, Arizona, United States

Anaheim Clinical Trials

Anaheim, California, United States

Center for Clinical Trials, LLC

Paramount, California, United States

California Research Foundation

San Diego, California, United States

Benchmark Research San Francisco

San Francisco, California, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, United States

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Rochester Clinical Research Inc.

Rochester, New York, United States

PMG Research of Cary, LLC

Cary, North Carolina, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Rapid Medical Research, Inc.

Cleveland, Ohio, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Benchmark Research Austin

Austin, Texas, United States

Benchmark Research

Fort Worth, Texas, United States

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

References

StatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.

Reference Type: BACKGROUND

Other Identifiers

721104

Identifier Type: -

Identifier Source: org_study_id