Last updated: 02/20/2024 08:51:12

The comparative efficacy, safety and tolerability of herpes zoster vaccines

GSK study ID
207814
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The comparative efficacy, safety and tolerability of herpes zoster vaccines
Trial description: The aim of this study is to compare the efficacy, safety, and reactogenicity of Herpes Zoster (HZ) vaccines by means of Network Meta-analysis (NMA) models.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence rate for relative HZ incidence.

Timeframe: During the entire duration of the follow-up

Incidence rate for relative PHN.

Timeframe: During the entire duration of the follow-up

Incidence rate of injection site reactions.

Timeframe: During the entire duration of the follow-up

Relative incidence of systemic reactions.

Timeframe: Entire study duration

Relative incidence of serious adverse events (SAEs).

Timeframe: Longest duration of follow up

Relative incidence serious adverse events (SAEs).

Timeframe: Up to 42 days

Secondary outcomes:
Not applicable
Interventions:
  • Vaccine: Zostavax
  • Drug: Placebo
  • Vaccine: Shingrix
    • Enrollment:
    108678
    Primary completion date:
    2018-15-02
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    December 2017 to February 2018
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Older adults ≥50 years of age (studies can be included when adults younger than 50 are included, so long as this is not the majority).
    • Any HZ vaccine (including all preparations, schedules, dosing and routes of administration)
    • Studies conducted in patients <50 years of age (wherein the majority of included patients are >50 years)
    • Patients with prior HZ infection
    Inclusion and exclusion criteria
    Inclusion criteria:

      Older adults ≥50 years of age (studies can be included when adults younger than 50 are included, so long as this is not the majority).

      • Any HZ vaccine (including all preparations, schedules, dosing and routes of administration)
      • Any HZ vaccine, including those that vary from the main intervention only with regards to the preparation, schedule, dose and/or route of administration
      • Placebo or no intervention
      • Incidence of HZ (entire duration of follow-up or repeated measures) a) Number of cases and person years b) Incidence rate per arm
      • Incidence of PHN (entire duration of follow-up) a) Number of cases and person years b) Incidence rate per arm
      • Incidence of other HZ complications (number/proportion of events or number/proportion of patients with event or incidence rate)
      • HZ Burden of Illness mean score
      • Injection site/local reactions (number/proportion with event)
      • Systemic/general reactions (number/proportion with event/ mean duration of symptoms)
      • Vaccine associated systemic/general reactions (number/proportion with event/ mean duration of symptoms)
      • Total discontinuations (number/proportion with event)
      • Serious Adverse Events (number/proportion of events or number/proportion of patients with event)
      • Randomized controlled trials
      • Conference proceedings that report original data
      • Pooled analyses of included trials where new data are available for outcomes of interest
    Exclusion criteria:

      Studies conducted in patients <50 years of age (wherein the majority of included patients are >50 years)

      • Patients with prior HZ infection
      • Studies conducted in immunocompromised patients (wherein no healthy patients were included)
      • Systematic reviews
      • Observational studies
      • Guidelines
      • Non-interventional studies
      • Pooled analyses where no new data are reported compared to original trials

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2018-15-02
    Actual study completion date
    2018-15-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website