E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Prevention of Herpes Zoster (HZ) and related complications in adults ≥50 years of age (YOA)) |
|
E.1.1.1 | Medical condition in easily understood language |
Herpes Zoster (Shingles) disease |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019974 |
E.1.2 | Term | Herpes zoster |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the vaccine response rate (VRR) to HZ/su (based on humoral immune response) one month after the second vaccine dose, when the first dose of HZ/su is co-administered with Prevenar13 (Co-Ad group).
To demonstrate non-inferiority of the humoral immune response to two doses of HZ/su at one month after the last vaccine dose, when the first dose of HZ/su is co-administered with Prevenar13 (Co-Ad group) compared to when two doses of HZ/su are administered subsequent to Prevenar13 (Control Group).
To demonstrate non-inferiority of the humoral immune response to Prevenar13 at one month after the vaccine dose, when Prevenar13 is co-administered with the first HZ/su dose (Co-Ad group) compared to when Prevenar13 is administered separately from HZ/su (Control group), for the 13 serotypes included in Prevenar13 analyzed sequentially.
Note: Objectives are herarchial. For criteria refer protocol. |
|
E.2.2 | Secondary objectives of the trial |
•To evaluate the safety and reactogenicity following administration of HZ/su and Prevenar13 vaccines, up to one month post last vaccination and during the whole follow-up period, in the Control group and the Co-Ad group. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•Written informed consent obtained from the subject prior to performance of any study specific procedure.
•A male or female, aged >= 50 YOA at the time of the first vaccination with the study vaccine(s).
•Female subjects of non-childbearing potential may be enrolled in the study.
•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 vac-cination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
|
|
E.4 | Principal exclusion criteria |
•Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
•Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
•Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of cortico-steroids (>14 consecutive days of prednisone at a dose of ≥ 20 mg/day [or equivalent]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
•Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
•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 and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period.
•History of HZ.
•History of documented pneumococcal infection within 5 previous years.
•Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines.
•Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
•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 enrollment.
Fever is defined as temperature >= 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
•Administration of immunoglobulins and/or any blood products during the period starting 3 months before 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 person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome and functional or anatomic asplenia.
•Any medical condition that in the judgment of the investigator would prevent the subject from participating in the study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of subjects with a vaccine response.
Anti-gE antibody concentrations.
Anti-pneumococcal antibody titers. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month post-dose 2, at Visit Month 3.
One month post-dose 2 (at Month 3 Visit for the Co-Ad and Month 5 Visit for the Control group).
At one month post-dose (Month 1). |
|
E.5.2 | Secondary end point(s) |
Number of subjects with any and Grade 3 solicited local symptoms.
Number of days with each solicited local symptom.
Number of subjects with any, Grade 3 and related solicited general symptoms.
Number of days with solicited general symptom.
Number of subjects with any, Grade 3 and related unsolicited AEs.
Number of subjects with any and related SAEs.
Number of subjects with any and related SAEs.
Number of subjects with any and related pIMDs.
Number of subjects with any and related pIMDs. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Within 7 days (Days 1 - 7) after each vaccination.
Within 7 days (Days 1 - 7) after each vaccination.
Within 7 days (Days 1 - 7) after each vaccination.
Within 7 days (Days 1 - 7) after each vaccination.
Within 30 days (Days 1 to 30) after each vaccination.
From first vaccination at Day 1 up to 30 days post last vaccination.
Starting after 30 days post last vaccination up to study end.
From first vaccination at Day 1 up to 30 days post last vaccination.
Starting after 30 days post last vaccination up to study end. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Estonia |
Germany |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last testing results released of samples collected at Visit Month 3 (Co-Ad group) or at Visit Month 5 (Control group) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 19 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 19 |