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Phase 3 Completed N=828 Randomized Prevention

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

OutcomeResultp-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,
View full record on ClinicalTrials.gov →

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.

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