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

NCT02218697 | Completed Phase 3 Results

• 2 other identifiers: 1172762014-001118-24
• Study Type: interventional
• Target: 357
• Locations: 2 countries
• Sites: 6

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

Keywords

Immunogenicity; Influsplit Tetra (Fluarix Tetra) 2014/2015 season; Safety; Adults; Pneumovax 23/Pneumovax; Co-administration; Elderly; Seasonal influenza; Pneumococcal infection

Outcome Measures

Primary Outcomes (2)

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

  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).

  At Day 28 post Influsplit™ Tetra vaccination

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

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

  At 28 days after Pneumovax™ 23 vaccination

Secondary Outcomes (15)

• Number of Subjects Reporting Solicited Local Adverse Events (AEs)

  Within 7 days (Days 0 - 6) after each dose and across doses.

• Number of Subjects Reporting Solicited General 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

• Duration of Solicited General AEs.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)

  Throughout the study period (Days 0-180)

Study Arms (2)

Co-Ad Group

EXPERIMENTAL

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.

Biological: Influsplit™ Tetra (Fluarix™ Tetra); Biological: Pneumovax™ 23; Biological: Placebo (Saline)

Control Group

EXPERIMENTAL

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.

Biological: Influsplit™ Tetra (Fluarix™ Tetra); Biological: Pneumovax™ 23; Biological: Placebo (Saline)

Interventions

Influsplit™ Tetra (Fluarix™ Tetra) BIOLOGICAL

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

Also known as: D-QIV, GSK2321138A

Co-Ad Group; Control Group

Pneumovax™ 23 BIOLOGICAL

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

Co-Ad Group; Control Group

Placebo (Saline) BIOLOGICAL

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

Co-Ad Group; Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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), …

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Angers, 49000, France

Location

GSK Investigational Site

Laval, 53000, France

Location

GSK Investigational Site

Nantes, 44277, France

Location

GSK Investigational Site

Saint-Cyr-sur-Loire, 37540, France

Location

GSK Investigational Site

Tours, 37100, France

Location

Related Publications (1)

• 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.

  PMID: 28987445 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; Pneumococcal Infections

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 18, 2014
• Study Start: October 1, 2014
• Primary Completion: January 14, 2015
• Study Completion: May 4, 2015
• Last Updated: April 3, 2018
• Results First Posted: March 9, 2017

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (5); BE (1)