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

Alachua Government Services, Inc.

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: VCIV manufactured with the current manufacturing process (VCIV current); Biological: Fluzone®, licensed trivalent influenza vaccine (TIV); Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01773928

721104

Details and patient eligibility

About

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.

Enrollment: 1,928 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,928 participants in 9 patient groups

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

Experimental group

Description:

Vero cell-derived trivalent influenza vaccine (VCIV)

Treatment:

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

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

Experimental group

Description:

Vero cell-derived trivalent influenza vaccine (VCIV)

Treatment:

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

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

Experimental group

Description:

Vero cell-derived trivalent influenza vaccine (VCIV)

Treatment:

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

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

Active Comparator group

Description:

Vero cell-derived trivalent influenza vaccine (VCIV)

Treatment:

Biological: VCIV manufactured with the current manufacturing process (VCIV current)

Fluzone® (18-49 Years Old)

Active Comparator group

Description:

Fluzone®, licensed trivalent influenza vaccine (TIV)

Treatment:

Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)

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

Experimental group

Description:

Vero cell-derived trivalent influenza vaccine (VCIV)

Treatment:

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

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

Experimental group

Description:

Vero cell-derived trivalent influenza vaccine (VCIV)

Treatment:

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

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

Experimental group

Description:

Vero cell-derived trivalent influenza vaccine (VCIV)

Treatment:

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

Fluzone® (≥50 Years Old)

Active Comparator group

Description:

Fluzone®, licensed trivalent influenza vaccine (TIV)

Treatment:

Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)