Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

NCT ID: NCT03439657

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 913 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-12
• Study Completion Date: 2020-03-03

Brief Summary

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.

Detailed Description

Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix. In addition, the term "candidate" vaccine has been replaced by "study" vaccine throughout the protocol.

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Co-Ad Group

Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

Group Type: EXPERIMENTAL

HZ/su vaccine GSK1437173A

Intervention Type: BIOLOGICAL

2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

Prevenar13

Intervention Type: BIOLOGICAL

1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.

Control Group

Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

Group Type: ACTIVE_COMPARATOR

HZ/su vaccine GSK1437173A

Intervention Type: BIOLOGICAL

2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

Prevenar13

Intervention Type: BIOLOGICAL

1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.

Interventions

HZ/su vaccine GSK1437173A

2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

Intervention Type: BIOLOGICAL

Prevenar13

1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

PCV13

Eligibility Criteria

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 vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

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 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.
• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Marlborough, Massachusetts, United States

GSK Investigational Site

Salisbury, North Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Rakvere, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Countries

United States; Canada; Estonia; Germany

References

Min JY, Mwakingwe-Omari A, Riley M, Molo LY, Soni J, Girard G, Danier J. The adjuvanted recombinant zoster vaccine co-administered with the 13-valent pneumococcal conjugate vaccine in adults aged >/=50 years: A randomized trial. J Infect. 2022 Apr;84(4):490-498. doi: 10.1016/j.jinf.2021.12.033. Epub 2021 Dec 25.

Reference Type: DERIVED

PMID: 34963639 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-001220-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

204487

Identifier Type: -

Identifier Source: org_study_id