Last updated: 01/22/2022 15:40:08

Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with Prevenar13 in adults aged 50 years and older

GSK study ID
204487
Clinicaltrials.gov ID
EudraCT ID
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: Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with Prevenar13 in adults aged 50 years and older
Trial description: The purpose of this study is to assess immunogenicity and safety of GSK Biologicals’ HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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)

Secondary outcomes:

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

Interventions:
  • Biological/vaccine: HZ/su vaccine GSK1437173A
  • Biological/vaccine: Prevenar13
  • Enrollment:
    913
    Primary completion date:
    2019-06-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Ji-Young Min, Agnes Mwakingwe-Omari, Meghan Riley, Lifeter Yenwo Molo, Jyoti Soni, Ginette Girard, Jasur Danier. The Adjuvanted Recombinant Zoster Vaccine Co-Administered with the 13-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥50 YEARS: A Randomized Trial. J Infect. 2021;ePub. DOI: http://dx.doi.org/ 10.1016/j.jinf.2021.12.033
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    April 2018 to March 2020
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    Yes
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Essen, Nordrhein-Westfalen, Germany, 45355
    Status
    Study Complete
    Location
    GSK Investigational Site
    Goch, Nordrhein-Westfalen, Germany, 47574
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55116
    Status
    Study Complete
    Location
    GSK Investigational Site
    Marlborough, Massachusetts, United States, 01752
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rakvere, Estonia, 44316
    Status
    Study Complete
    Location
    GSK Investigational Site
    Salisbury, North Carolina, United States, 28144
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Protocol
    Available language(s): English
    Statistical analysis plan
    Available language(s): English

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2019-06-05
    Actual study completion date
    2020-03-03

    Plain language summaries

    Summary of results in plain language
    Available language(s): English, French (Canadian), Estonian, Russian (Estonia), German, Spanish (United States)

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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