Phase 3
Completed N=356
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
Source: ClinicalTrials.gov NCT02218697 ↗Enrolled (actual)
356
Serious AEs
5.1%
Results posted
Mar 2017
Primary outcomePrimary: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. — 253.2; 235.5; 73.6; 78.6 Titers
◆ Published Evidence
Established
32citations · ~4 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. |
253.2; 235.5; 73.6; 78.6; 178.7; 157.9 | — |
| PRIMARY Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). |
5.5; 4.9; 1.7; 1.7; 2.3; 1.7 | — |
| SECONDARY Number of Subjects Reporting Solicited Local Adverse Events (AEs) |
28; 58; 0; 2; 10; 0 | — |
| SECONDARY Number of Subjects Reporting Solicited General Adverse Events (AEs) |
30; 39; 1; 2; 23; 33 | — |
| SECONDARY Duration of Local Adverse Events |
2.0; 2.0; 2.0; 2.0; 4.0; 2.0 | — |
| SECONDARY Duration of Solicited General AEs. |
2.0; 2.0; 3.0; 3.5; 2.0; 2.0 | — |
| SECONDARY Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs) |
37; 43; 2; 2 | — |
| SECONDARY Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs) |
0; 1; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
35; 42; 5; 8; 5; 5 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
11; 7; 0; 0; 0; 1 | — |
| SECONDARY 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 |
32.4; 253.2; 34.0; 235.5; 20.8; 21.8 | — |
| SECONDARY Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
83; 77; 160; 157; 57; 50 | — |
| SECONDARY Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
110; 101; 62; 61; 73; 55 | — |
| SECONDARY Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. |
7.7; 6.9; 3.5; 3.6; 3.6; 3.1 | — |
| SECONDARY 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 |
162; 152; 169; 162; 112; 118 | — |
| SECONDARY 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) |
0.4; 0.4; 5.5; 4.9; 0.4; 0.5 | — |
| SECONDARY 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. |
149; 144; 134; 126; 121; 97 | — |
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 pneumoc
Data sourced from ClinicalTrials.gov (NCT02218697) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.