A Phase IV, Randomized, Observer-blind, Placebo-controlled, Multi-center Study to Assess the Prophylactic Efficacy Against Herpes Zoster, Immunogenicity and Safety of Shingrix When Administered Intramuscularly on a 2-dose Schedule in Chinese Adults Aged 50 Years and Older

GlaxoSmithKline1 site in 1 country6,138 target enrollmentMay 14, 2021

ConditionsHerpes Zoster

InterventionsRZV Placebo

DrugsRZV Placebo

Overview

Phase: Phase 4
Intervention: RZV
Conditions: Herpes Zoster
Sponsor: GlaxoSmithKline
Enrollment: 6138
Locations: 1
Primary Endpoint: Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess vaccine efficacy (VE), ability to generate immune response and safety of two doses of the recombinant subunit zoster vaccine (RZV) for prevention of Herpes Zoster (HZ) in Chinese adults aged 50 years and older.

Registry

clinicaltrials.gov

Start Date

May 14, 2021

End Date

April 20, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
•Written or witnessed/thumb printed informed consent obtained from the subject/subject's LAR prior to performance of any study specific procedure.
•A male or female aged 50 years or older at the time of the first vaccination.
•Medically stable subjects as established by medical history and history-directed clinical examination before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
•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
•has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria

•Medical conditions
•Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
•History of HZ.
•Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study materials and equipment.
•Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
•Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
•Prior/Concomitant therapy
•Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
•Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after the last dose of vaccine administration. However, licensed pneumococcal vaccines and inactivated and subunit influenza vaccines (without adjuvant for seasonal or pandemic flu) may be co- administered with any dose of study vaccine.

Arms & Interventions

RZV Group

Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.

Intervention: RZV

Placebo Group

Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence Rate of Confirmed Herpes Zoster (HZ) Cases

Time Frame: From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)

A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.

Secondary Outcomes

Incidence Rate of Confirmed HZ Cases, by Age Category(From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years))
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit(Within 7 days after each vaccination (occurring at Day 1 and Month 2))
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit(Within 7 days after each vaccination (occurring at Day 1 and Month 2))
Number of Participants With at Least One Unsolicited AE, at Least One Grade 3 Unsolicited AE, at Least One Related Unsolicited AE, at Least One Grade 3 Related Unsolicited AE and With at Least One Medically Attended Unsolicited AE(Within 30 days after any vaccination (occurring at Day 1 and Month 2))
Number of Participants With at Least One Serious Adverse Event (SAE) and With at Least One Related SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination(From first vaccination (Day 1) up to 30 days post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
Number of Participants With at Least One SAE and With at Least One Related SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination(From first vaccination (Day 1) up to 12 months post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
Number of Participants With at Least One Related SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)(From first vaccination (Day 1) up to study end (duration of approximately 2 years))
Number of Participants With at Least One SAE Related to Study Participation or to GlaxoSmithKline Concomitant Medication/Vaccine(From the time the participant consented to participate in the study (Day 1) up to study end (duration of approximately 2 years))
Number of Participants With at Least One Fatal SAE and at Least One Related Fatal SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination(From first vaccination (Day 1) up to 30 days post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
Number of Participants With at Least One Fatal SAE and With at Least One Related Fatal SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination(From first vaccination (Day 1) up to 12 months post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
Number of Participants With at Least One Related Fatal SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)(From first vaccination (Day 1) up to study end (duration of approximately 2 years))
Number of Participants With at Least One Potential Immune-mediated Disease (pIMD) and at Least One Related pIMD From First Vaccination (Day 1) up to 30 Days Post Last Vaccination(From first vaccination (Day 1) up to 30 days post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
Number of Participants With at Least One pIMD and at Least One Related pIMD From First Vaccination (Day 1) up to 12 Months Post Last Vaccination(From first vaccination (Day 1) up to 12 months post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
Number of Participants With at Least One Related Serious pIMD From 12 Months Post Last Vaccination up to Study End (Duration of Approximately 1 Year)(From 12 months post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses) up to study end (duration of approximately 1 year))