Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Herpes Zoster

Treatments: Procedure: Blood sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT01295320

114825

Details and patient eligibility

About

The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.

This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.

The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.

Enrollment: 129 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol
• Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
• Written informed consent obtained from the subject

Exclusion criteria

• Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product or; 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 product
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
• Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577
• Having received a vaccine against HZ any time after study end of study NCT00434577
• Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

GSK1437173A Group

Experimental group

Description:

Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).

Treatment:

Procedure: Blood sample