Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older

GlaxoSmithKline1 site in 1 country357 target enrollmentOctober 1, 2014

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: GlaxoSmithKline
Enrollment: 357
Locations: 1
Primary Endpoint: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the immunogenicity and safety when GSK Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections.

Registry

clinicaltrials.gov

Start Date

October 1, 2014

End Date

May 4, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
•A male or female aged 50 years or above at the time of the first vaccination at risk for complications from influenza and/or pneumococcal infections, meeting their respective countries' recommendations for vaccination against influenza and pneumococcal disease.
•At risk subjects include adults with chronic respiratory, heart, kidney, liver or neurological disease; human immunodeficiency virus (HIV) disease on combination antiretroviral therapy (cART) with cluster of differentiation 4 (CD4) T-cell counts greater than 350 cells/mm3; sickle cell disease or coeliac syndrome that may lead to splenic dysfunction (all other asplenics are excluded). The decision to enrol should be based on the investigators clinical judgement.
•Written informed consent obtained from the subject.
•Female subjects of non-childbearing potential may be enrolled in the study.
•Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
•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

•Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled, topical and low-dose intra-articular steroids are allowed.
•Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose and 30 days after the last dose of vaccine.
•Administration of such a vaccine has to be documented in the "Concomitant vaccination" of the electronic Case Report Form (eCRF).
•Administration of long-acting immune-modifying drugs/treatment within six months prior to the first vaccine dose or expected administration at any time during the study period. These immunosuppressant drugs/treatment/Biologics include:
•Methotrexate
•Leflunomide
•Azathioprine and 6-mercaptopurine
•Cyclosporin A
•Cyclophosphamide

Outcomes

Primary Outcomes

Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.

Time Frame: At Day 28 post Influsplit™ Tetra vaccination

HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).

Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).

Time Frame: At 28 days after Pneumovax™ 23 vaccination

Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).

Secondary Outcomes

Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)(Throughout the study period (Days 0-180))
Number of Subjects Reporting Solicited General Adverse Events (AEs)(Within 7 days (Days 0 - 6) after each dose and across doses.)
Duration of Solicited General AEs.(During the 7-day (Days 0-6) post-vaccination period)
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains(At Day 0 and Day 28)
Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.(At 28 days post-vaccination with Pneumovax™ 23)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(Within the 28-day (Days 0-27) post-vaccination period)
Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.(At Day 28)
Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F(At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only))
Number of Subjects Reporting Solicited Local Adverse Events (AEs)(Within 7 days (Days 0 - 6) after each dose and across doses.)
Duration of Local Adverse Events(During the 7-day (Days 0-6) post-vaccination period)
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.(At Day 0 and Day 28)
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.(At Day 28)
Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)(During the entire study period (Days 0-180))
Number of Subjects Reporting Serious Adverse Events (SAEs)(Throughout the study period (Days 0-180))
Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)(At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only))