Evaluation of the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older

NCT ID: NCT02218697

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2015-05-04

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Co-Ad Group

Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.

Group Type: EXPERIMENTAL

Influsplit™ Tetra (Fluarix™ Tetra)

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Pneumovax™ 23

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Placebo (Saline)

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Control Group

Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.

Group Type: EXPERIMENTAL

Influsplit™ Tetra (Fluarix™ Tetra)

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Pneumovax™ 23

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Placebo (Saline)

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Interventions

Influsplit™ Tetra (Fluarix™ Tetra)

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Intervention Type: BIOLOGICAL

Pneumovax™ 23

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Intervention Type: BIOLOGICAL

Placebo (Saline)

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Intervention Type: BIOLOGICAL

Other Intervention Names

D-QIV; GSK2321138A

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
• Tacrolimus, everolimus, sirolimus, temsirolimus
• Mycophenolate mofetil
• Antilymfocytaire immunoglobulins
• Tumor Necrosis Factor (TNF) inhibitors: Adalimumab (Humira®), certolizumab (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®) and infliximab(Remicade®)
• Monoclonal antibodies and other biologicals: Rituximab (Mabthera®), Abatacept (Orencia®), tocilizumab (RoActemra®), basiliximab (Simulect®), Natalizumab (Tysabri®) cluster of differentiation 3 (CD3), …
• Antitumor agents: alkylating agents, antimetabolites, antitumor antibiotics, topoisomerase inhibitors, microtubule inhibitors and other anti-tumor agents
• Lenalidomide Revlimid®
• Tasonermin: Beromun®
• Proleukin® (aldesleukin; Novartis, …)
• Tyrosine kinase inhibitor (Glivec®)Omalizumab Xolair®
• Eculizumab Soliris® The above list is compiled from: [Federal Public Service Belgium: Health, Food Chain Safety and Environment].
• Any immunosuppressive treatment which in the opinion of the investigator will not allow an adequate immune response. Inhaled, topical and low-dose intra-articular steroids are allowed.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• Previous vaccination with a pneumococcal vaccine within the last five years.
• Previous vaccination with an influenza vaccine within the last six months.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. HIV infected subjects on cART with CD4 T-cell counts above 350 cells/mm3 can be enrolled.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥ 38.0°C (100.4°F). The preferred route for recording temperature in this study will be axillary.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever [≥ 38.0°C (100.4°F)] may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular (IM) injection unsafe.
• Asplenia or dysfunction of the spleen. This excludes homozygous sickle cell disease or coeliac syndrome that may lead to splenic dysfunction.
• Acute clinically significant (i.e. a medically significant change from baseline condition in the past 30 days) pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• History of chronic alcohol consumption and/or drug abuse.
• History of Guillain-Barré syndrome.
• A history of anaphylaxis following ANY vaccination.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Angers, , France

GSK Investigational Site

Laval, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Saint-Cyr-sur-Loire, , France

GSK Investigational Site

Tours, , France

Countries

Belgium; France

References

Ofori-Anyinam O, Leroux-Roels G, Drame M, Aerssens A, Maes C, Amanullah A, Schuind A, Li P, Jain VK, Innis BL. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults >/=50years of age: Results from a phase III, randomized, non-inferiority trial. Vaccine. 2017 Nov 1;35(46):6321-6328. doi: 10.1016/j.vaccine.2017.09.012. Epub 2017 Oct 5.

Reference Type: DERIVED

PMID: 28987445 (View on PubMed)

Study Documents

Document Type: Dataset Specification

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Informed Consent Form

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

View Document

Document Type: Individual Participant Data Set

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

2014-001118-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

117276

Identifier Type: -

Identifier Source: org_study_id