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

• ClinicalTrials.gov Identifier: NCT01153685
• Recruitment Status: Completed
• First Posted: June 30, 2010
• Results First Posted: November 17, 2011
• Last Update Posted: June 8, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Fluviral®	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety Study of GSK Biologicals' (GSK1536489A) Trivalent Split Virion Influenza Vaccine Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years.
• Study Start Date: July 9, 2010
• Actual Primary Completion Date: July 31, 2010
• Actual Study Completion Date: July 31, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fluviral A Group; 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®; Intramuscular injection, one dose
Experimental: Fluviral B Group; 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®; Intramuscular injection, one dose

Outcome Measures

Primary Outcome Measures :

1. Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. [ Time Frame: At Day 0 before vaccination ]
   The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
2. Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. [ Time Frame: At Day 21 after vaccination ]
   The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
3. Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. [ Time Frame: At Day 0 before vaccination ]
   A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
4. Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. [ Time Frame: At Day 21 after vaccination ]
   A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
5. Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains. [ Time Frame: At Day 21 after vaccination ]
   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.
6. Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains. [ Time Frame: At Day 21 after vaccination ]
   Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).

Secondary Outcome Measures :

1. Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. [ Time Frame: During a 4-days (Day 0-3) follow-up period after vaccination. ]
   Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)
2. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within the 21-day post-vaccination period ]

   Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms.

   Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination.

   Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination.

3. Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: Within the 21-day post-vaccination period ]
   Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
4. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period ]
   SAEs assessed include medical occurences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
• Complicated insulin-dependent diabetes mellitus.
• Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
• Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
• Receipt of systemic glucocorticoids (prednisone >= 20 mg/day for more than 14 consecutive days) within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.
• A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
• Presence of an active neurological disorder.
• History of chronic alcohol consumption and/or drug abuse.
• Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Any known or suspected allergy to any constituent of Fluviral (egg protein, thimerosal) and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury (such as thimerosal).
• A history of severe adverse reaction to a previous influenza vaccination.
• Pregnant and/or lactating/nursing female.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Contacts and Locations

Locations

Canada, Quebec

GSK Investigational Site

Sherbrooke, Quebec, Canada, J1H 1Z1

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

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

Study Data/Documents: Study Protocol 

Identifier: 110628
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 110628
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 110628
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 110628
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 110628
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 110628
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01153685
• Other Study ID Numbers: 110628
• First Posted: June 30, 2010
• Results First Posted: November 17, 2011
• Last Update Posted: June 8, 2018
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

Fluviral®Influenza

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases