Phase 3
Completed N=828
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
Source: ClinicalTrials.gov NCT01954251 ↗Enrolled (actual)
828
Serious AEs
9.8%
Results posted
Feb 2016
Primary outcomePrimary: Number of Subjects With Vaccine Response to Anti-gE Antibodies — 366 Subjects
Summary
The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Vaccine Response to Anti-gE Antibodies |
366 | — |
| PRIMARY Vaccine Response for Anti-gE Humoral Immunogenicity |
95.8 | — |
| PRIMARY Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies |
52151.6; 56247.4 | — |
| PRIMARY FLU Haemagglutination Inhibition (HI) Antibody Titers |
29; 24.9; 196.2; 193.2; 19.6; 19.0 | — |
| SECONDARY Number of Subjects With FLU HI Antibody Titers ≥1:10 |
288; 294; 381; 389; 283; 300 | — |
| SECONDARY Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40 |
185; 161; 347; 360; 134; 121 | — |
| SECONDARY FLU Haemagglutination Inhibition (HI) Antibody Titers |
29; 24.9; 196.2; 193.2; 19.6; 19.0 | — |
| SECONDARY Number of Seroconverted Subjects in Terms of HI Antibodies |
232; 240; 136; 139; 143; 169 | — |
| SECONDARY Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer |
6.8; 7.7; 3.4; 3.5; 3.4; 3.8 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
344; 318; 55; 40; 153; 144 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
344; 318; 55; 40; 153; 144 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
154; 135; 23; 24; 121; 110 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
154; 135; 23; 24; 121; 110 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
110; 162; 17; 29; 18; 26 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
42; 39 | — |
| SECONDARY Number of Subjects With Potential Immune-mediated Diseases (pIMDs) |
4; 2 | — |
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 older, at the time of the first vaccination with the study vaccine(s).
- 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 (drug or vaccine) 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 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) (HZ/su and/or FLU-D-QIV vaccines) and ending 30 days after the last dose of HZ/su vaccine.
- Administration of an influenza vaccine during the six months preceding entry into the study or planned administration up to the last blood sampling with the exception of the FLU-D-QIV vaccine given during this study.
- Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
- 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 (pharmaceutical product or device).
- Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
- History of HZ.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- History of Guillain Barré syndrome.
- Hypersensitivity to latex.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the 3 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 before 2 months after the last dose of study vaccine.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- Any condition which,
Data sourced from ClinicalTrials.gov (NCT01954251). 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.