A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above

NCT01607112 | Completed Phase 3 Results

• 2 other identifiers: 1166632012-000789-39
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).

Conditions

Influenza

Keywords

Influenza; Healthy; Immunogenicity; Elderly; Safety; Adults

Outcome Measures

Primary Outcomes (5)

• Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains

  Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).

  At Day 0 and Day 21

• Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.

  Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.

  At Day 0 and Day 21

• Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.

  A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

  At Day 21

• Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.

  MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.

  At Day 21

• Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.

  SPP was defined as the number of vaccinees with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40.

  At Day 21

Secondary Outcomes (10)

• Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.

  At Day 0 and Day 21

• Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.

  At Day 0 and Day 21

• Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.

  At Day 21

• Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.

  At Day 21

• Duration of Solicited Local Symptoms.

  During the 4-day follow-up period (Days 0-3) after vaccination

Study Arms (2)

Fluarix/Influsplit 18-60 Years Group

EXPERIMENTAL

Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Biological: Fluarix/Influsplit SSW 2012-2013

Fluarix/Influsplit > 60 Years Group

EXPERIMENTAL

Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Biological: Fluarix/Influsplit SSW 2012-2013

Interventions

Fluarix/Influsplit SSW 2012-2013 BIOLOGICAL

1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm

Fluarix/Influsplit 18-60 Years Group; Fluarix/Influsplit > 60 Years 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 can and will comply with the requirements of the protocol.
• A male or female aged 18 years or above at the time of vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
• 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 vaccination.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
• Administration of an influenza vaccine within the six months preceding the study vaccination.
• Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
• Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
• Acute disease and/or fever at the time of enrolment.
• Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Chronic underlying disease, not stabilized or clinically serious.
• History of chronic alcohol consumption and/or drug abuse.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of Guillain-Barré syndrome.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Anaphylaxis following the administration of vaccine(s).
• Pregnant or lactating female.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Dresden, Saxony, 01097, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01099, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01129, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01309, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

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

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: May 24, 2012
• First Posted: May 28, 2012
• Study Start: July 10, 2012
• Primary Completion: July 31, 2012
• Study Completion: July 31, 2012
• Last Updated: September 7, 2018
• Results First Posted: December 6, 2013

Record last verified: 2013-11

Locations

DE (4)