Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with Prevenar13 in adults aged 50 years and older
Trial overview
Percentage of subjects with a Vaccine response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group
Timeframe: One month post-dose 2 (Month 3)
Anti-gE antibody concentrations
Timeframe: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Anti-pneumococcal antibody titers
Timeframe: At one month post-dose 1 (Month 1)
Adjusted Geometric Mean Concentrations (GMCs) for anti-gE antibody
Timeframe: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Adjusted Geometric Mean Titers (GMTs) of anti-pneumococcal antibodies
Timeframe: At one month post-dose 1 (Month 1)
Number of subjects with any and grade 3 solicited local symptoms by vaccine and dose
Timeframe: Within 7 days (Day 1 - 7) after each vaccination
Number of days with each solicited local symptoms
Timeframe: Within 7 days (Day 1 - 7) after each vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: Within 7 days (Day 1 - 7) after each vaccination
Number of days with solicited general symptoms
Timeframe: Within 7 days (Day 1 - 7) after each vaccination
Number of subjects with any, Grade 3 and related unsolicited Adverse Events (AE)
Timeframe: Within 30 days (Day 1 to 30) after each vaccination
Number of subjects with any and related Serious Adverse Events (SAE) from Day 1 to 30 days post last vaccination
Timeframe: From first vaccination at Day 1 up to 30 days post last vaccination
Number of subjects with any and related SAEs from 30 days post last vaccination up to study end.
Timeframe: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Number of subjects with any and related Potential immune-mediated diseases (pIMDs) from Day 1 to 30 days post last vaccination
Timeframe: From first vaccination at Day 1 up to 30 days post last vaccination.
Number of subjects with any pIMDs from 30 days post last vaccination up to study end.
Timeframe: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Number of subjects with any and Grade 3 solicited local symptoms by dose
Timeframe: Within 7 days (Day 1 - 7) after each vaccination
- 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.
- 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.
- 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 vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- 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 corticosteroids (>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.
- 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.
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.
Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
To view plain language summaries on trialsummaries.com click here.