NCT00566345

Brief Summary

The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,670

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
15.4 years until next milestone

Results Posted

Study results publicly available

October 17, 2023

Completed
Last Updated

October 17, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

November 30, 2007

Results QC Date

November 21, 2020

Last Update Submit

September 22, 2023

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens

    21 days to 180 days after the date of vaccination

  • The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values

    Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set.

    21 Days after vaccination

Secondary Outcomes (1)

  • Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination

    During the entire 180-day follow-up period

Study Arms (2)

Influenza vaccine

EXPERIMENTAL

Vero-cell derived influenza vaccine

Biological: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)

Placebo

PLACEBO COMPARATOR

Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)

Other: Phosphate buffered saline

Interventions

Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)BIOLOGICAL

Trivalent, non-adjuvanted vaccine; dose: 0.5 ml

Influenza vaccine
Phosphate buffered salineOTHER

Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female subjects who
  • are 18 to 49 years of age, inclusive, on the day of screening
  • have an understanding of the study, agree to its provisions and give written informed consent prior to study entry
  • If female and capable of bearing children - have a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate two types of the following FDA approved birth control measures through 60 days after the vaccination: hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR an additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).

You may not qualify if:

  • Subjects who have any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC):
  • pregnancy
  • chronic disorders of the pulmonary or cardiovascular system including asthma (hypertension is not considered a high risk condition)
  • chronic renal disorders
  • chronic hepatic disorders
  • chronic hematological disorders
  • chronic metabolic disorder (including diabetes mellitus)
  • immunosuppression (including immunosuppression caused by medications or HIV)
  • any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders or other neuromuscular disorders)
  • residence in a nursing home or other chronic care facility that houses persons of any age who have chronic medical conditions
  • household contact with children aged 0 to 59 months or of someone who is included in the risk categories listed above
  • employment as a health care worker
  • Subjects are also excluded if they
  • are unable to lead an independent life as a result of either physical or mental handicap
  • have a history of severe allergic reactions or anaphylaxis
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Clearwater, Florida, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

South Miami, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Lenexa, Kansas, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Metairie, Louisiana, United States

Location

Unknown Facility

Columbia, Maryland, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Goose Creek, South Carolina, United States

Location

Unknown Facility

Spartanburg, South Carolina, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

Plano, Texas, United States

Location

Unknown Facility

San Angelo, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Related Publications (3)

  • Ehrlich HJ, Singer J, Berezuk G, Fritsch S, Aichinger G, Hart MK, El-Amin W, Portsmouth D, Kistner O, Barrett PN. A cell culture-derived influenza vaccine provides consistent protection against infection and reduces the duration and severity of disease in infected individuals. Clin Infect Dis. 2012 Apr;54(7):946-54. doi: 10.1093/cid/cir959. Epub 2012 Jan 19.

    PMID: 22267715DERIVED

  • Ehrlich HJ, Berezuk G, Fritsch S, Aichinger G, Singer J, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine. 2012 Jun 19;30(29):4377-86. doi: 10.1016/j.vaccine.2011.11.114. Epub 2011 Dec 13.

    PMID: 22172502DERIVED

  • Barrett PN, Berezuk G, Fritsch S, Aichinger G, Hart MK, El-Amin W, Kistner O, Ehrlich HJ. Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2011 Feb 26;377(9767):751-9. doi: 10.1016/S0140-6736(10)62228-3. Epub 2011 Feb 15.

    PMID: 21329971DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Sr. Manager, Clinical & Regulatory Operations
Organization
Ology Bioservices
angie.kimbler@ologybio.com
386-418-8751

Study Officials

  • Karen Near, MD

    Baxter Healthcare Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 3, 2007

Study Start

November 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

October 17, 2023

Results First Posted

October 17, 2023

Record last verified: 2023-07

Locations

US(34)