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Completed

NCT Number: NCT01773928

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

East Valley Family Physicians, PLC, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

VCIV manufactured with the current manufacturing process (VCIV current)

Biological

Fluzone®, licensed trivalent influenza vaccine (TIV)

Biological

Primary outcomes

  1. Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine

    Time frame: 21 days post vaccination

    Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine

    Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed:

    Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency

  2. Non-inferiority of Modified Manufacturing Process Compared to the Current Process

    Time frame: 21 days post vaccination

    Non-inferiority of modified manufacturing process compared to the current process.

    Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol analysis dataset for participants 18-49 Years Old treated with Vero cell-derived trivalent influenza vaccine (VCIV) from the modified manufacturing process and VCIV manufactured with the current process

  3. Lot Consistency of the Three Modified Manufacturing Process Lots

    Time frame: 21 days post vaccination

    Lot consistency of the three modified manufacturing process lots Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol Analysis Dataset for participants of all ages treated with three Vero cell-derived trivalent influenza vaccine (VCIV) lots manufactured from the modified process.

  4. Percentage of Participants With Fever

    Time frame: onset within 7 days post vaccination

    Percentage of participants with fever

Secondary outcomes

  1. Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens

    Time frame: 21 days post vaccination

    Percentage of participants with seroprotective antibody titer [reciprocal HIA titer ≥40] for each of the three antigens contained in the vaccine

  2. Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine

    Time frame: 21 days post vaccination

    Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline OR a reciprocal HIA titer ≥ 40 when there is no detectable HIA titer (reciprocal HIA titer < 10) at baseline

  3. Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline

    Time frame: 21 days post vaccination

  4. Percentage of Participants With Solicited Systemic Reactions

    Time frame: within 7 days post vaccination

  5. Percentage of Participants With Injection Site Reactions

    Time frame: within 7 days post vaccination

  6. Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction

    Time frame: within 7 days post vaccination

  7. Percentage of Participants With Adverse Events

    Time frame: within 21 days post vaccination

  8. Frequency and Severity of Related Adverse Events

    Time frame: within 21 days post vaccination

    Frequency and severity of adverse events considered related to the vaccination (possibly related, probably related, unknown) according to System Organ Class (SOC) and Preferred Term (PT) SOCs are abbreviated as follows:- BLD- Blood and lymphatic system disorders EAR- Ear and labyrinth disorders EYE- Eye disorders GID- Gastrointestinal disorders GEN- General disorders and administration site conditions IMM- Immune system disorders INF- Infections and infestations MET- Metabolism and nutrition disorders MSK- Musculoskeletal and connective tissue disorders NER- Nervous system disorders RES- Respiratory, thoracic and mediastinal disorders SKN- Skin and subcutaneous tissue disorders VAS- Vascular disorders

    SYS-Systemic LOC-Local

Sponsors and collaborators

Lead sponsor

Alachua Government Services, Inc.

Industry

Registry information

Official study title

Randomized, Age-stratified, Double Blind, Controlled Phase 3 Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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