Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) (NCT NCT01527370)

Results Overview

Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

250 participants

Primary outcome timeframe

Prevaccination up to 6 weeks postvaccination

Results posted on

2018-09-18

Participant Flow

Ten sites in India enrolled adult participants in the study.

Participant milestones

Participant milestones
Measure	Zoster Vaccine Live A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Overall Study STARTED	250
Overall Study COMPLETED	244
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Zoster Vaccine Live A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1
Overall Study Death	1

Baseline Characteristics

Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoster Vaccine Live n=250 Participants A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Age, Continuous	58.6 Years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prevaccination up to 6 weeks postvaccination

Population: This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.

Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).

Outcome measures

Outcome measures
Measure	Zoster Vaccine Live n=250 Participants A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination Prevaccination (n=250)	149.8 gpELISA units/mL Interval 132.6 to 169.2
The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination 6 weeks postvaccination (n=243)	410.8 gpELISA units/mL Interval 373.0 to 452.6

PRIMARY outcome

Timeframe: Prevaccination up to 6 weeks postvaccination

Population: This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.

GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.

Outcome measures

Outcome measures
Measure	Zoster Vaccine Live n=243 Participants A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination	2.8 Ratio Interval 2.5 to 3.1

PRIMARY outcome

Timeframe: Up to 42 days postvaccination

Population: This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data.

A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

Outcome measures

Outcome measures
Measure	Zoster Vaccine Live n=250 Participants A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Number of Participants With Serious Adverse Events	2 Participants

Adverse Events

Zoster Vaccine Live

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zoster Vaccine Live n=250 participants at risk A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Gastrointestinal disorders Abdominal pain	0.40% 1/250 • Number of events 1 • Day 1 up to day 42 postvaccinaton Adverse events were collected from all participants who were vaccinated and had any safety follow up data.
Infections and infestations Bronchitis	0.40% 1/250 • Number of events 1 • Day 1 up to day 42 postvaccinaton Adverse events were collected from all participants who were vaccinated and had any safety follow up data.

Other adverse events

Other adverse events
Measure	Zoster Vaccine Live n=250 participants at risk A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
General disorders Injection site erythema	14.0% 35/250 • Number of events 36 • Day 1 up to day 42 postvaccinaton Adverse events were collected from all participants who were vaccinated and had any safety follow up data.
General disorders Injection site pain	8.8% 22/250 • Number of events 24 • Day 1 up to day 42 postvaccinaton Adverse events were collected from all participants who were vaccinated and had any safety follow up data.
General disorders Injection site swelling	12.4% 31/250 • Number of events 33 • Day 1 up to day 42 postvaccinaton Adverse events were collected from all participants who were vaccinated and had any safety follow up data.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER