Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years

NCT01153685 | Completed Phase 3 Results

• 1 other identifier: 110628
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years.

Conditions

Influenza

Keywords

Fluviral®Influenza

Outcome Measures

Primary Outcomes (6)

• Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.

  The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane

  At Day 0 before vaccination

• Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.

  The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane

  At Day 21 after vaccination

• Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.

  A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.

  At Day 0 before vaccination

• Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.

  A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.

  At Day 21 after vaccination

• Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.

  A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

  At Day 21 after vaccination

• Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.

  Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).

  At Day 21 after vaccination

Secondary Outcomes (4)

• Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.

  During a 4-days (Day 0-3) follow-up period after vaccination.

• Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

  Within the 21-day post-vaccination period

• Number of Subjects Reporting Unsolicited Adverse Events (AEs).

  Within the 21-day post-vaccination period

• Number of Subjects With Serious Adverse Events (SAEs)

  During the entire study period

Study Arms (2)

Fluviral A Group

EXPERIMENTAL

Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluviral®

Fluviral B Group

EXPERIMENTAL

Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluviral®

Interventions

Fluviral® BIOLOGICAL

Intramuscular injection, one dose

Fluviral A Group; Fluviral B Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject
• Male and female adults, 18 to 60 years of age and over 60 years of age.
• Satisfactory baseline medical assessment by history and physical examination
• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if:

• Participation in previous year's (2009) Fluviral registration study
• Administration of any influenza vaccine within 6 months preceding the study start (35 or more subjects in the \>60 year old age stratum will be recruited from among those who did NOT receive any inactivated influenza vaccine in 2009-2010 season, i.e. seasonal TIV or pandemic H1N1v).
• Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort.
• Clinically or virologically confirmed influenza infection within 1 year preceding the study start.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature \<38.0°C.
• Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:
• Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or
• Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or
• Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
• Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.
• Any confirmed or suspected immunosuppressive condition including:
• History of human immunodeficiency virus (HIV) infection,
• Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
• History of renal impairment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Publications (1)

• Jain VK, Chandrasekaran V, Wang L, Li P, Liu A, Innis BL. A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine. BMC Infect Dis. 2014 Mar 10;14:133. doi: 10.1186/1471-2334-14-133.

  PMID: 24606983 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: July 9, 2010
• Primary Completion: July 31, 2010
• Study Completion: July 31, 2010
• Last Updated: June 8, 2018
• Results First Posted: November 17, 2011

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)