Trial Outcomes & Findings for ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034) (NCT NCT01556451)

Results Overview

Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

180 participants

Primary outcome timeframe

Day 1 (Baseline) and Week 4 postvaccination

Results posted on

2017-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Zoster Vaccine Live Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Overall Study STARTED	180
Overall Study COMPLETED	180
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoster Vaccine Live n=180 Participants Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Age, Customized Between 50 and 59 years	89 Participants n=5 Participants
Age, Customized 60 years or older	91 Participants n=5 Participants
Sex: Female, Male Female	136 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (Baseline) and Week 4 postvaccination

Population: The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures

Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).

Outcome measures

Outcome measures
Measure	Zoster Vaccine Live n=166 Participants Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody	2.8 Ratio Interval 2.5 to 3.1

PRIMARY outcome

Timeframe: Day 1 (Baseline) and 4 weeks postvaccination

Population: The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures

Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV

Outcome measures

Outcome measures
Measure	Zoster Vaccine Live n=166 Participants Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Geometric Mean Titer (GMT) of VZV Antibody Day 1 (Baseline)	66.9 gpELISA units/mL Interval 59.2 to 75.5
Geometric Mean Titer (GMT) of VZV Antibody Week 4 postvaccination	185.4 gpELISA units/mL Interval 167.0 to 205.9

PRIMARY outcome

Timeframe: Up to 42 days postvaccination

Population: Safety population which included all vaccinated participants who had any safety follow-up

An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.

Outcome measures

Outcome measures
Measure	Zoster Vaccine Live n=180 Participants Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Percentage of Participants With Clinical Adverse Experiences Injection site adverse experiences	53.3 Percentage of Participants
Percentage of Participants With Clinical Adverse Experiences Non-injection site adverse experiences	24.4 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 42 days postvaccination

Population: Safety population which included all vaccinated participants who had any safety follow-up

Outcome measures

Outcome measures
Measure	Zoster Vaccine Live n=180 Participants Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Percentage of Participants Discontinued Due to Clinical Adverse Experiences	0 Percentage of Participants

Adverse Events

Zoster Vaccine Live

Serious events: 3 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zoster Vaccine Live n=180 participants at risk Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Gastrointestinal disorders Anal Fistula	0.56% 1/180 • Number of events 1 • Up to 42 days postvaccination
Gastrointestinal disorders Gastric Polyps	0.56% 1/180 • Number of events 1 • Up to 42 days postvaccination
Injury, poisoning and procedural complications Spinal Compression Fracture	0.56% 1/180 • Number of events 1 • Up to 42 days postvaccination

Other adverse events

Other adverse events
Measure	Zoster Vaccine Live n=180 participants at risk Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
General disorders Injection-Site Erythema	45.0% 81/180 • Number of events 81 • Up to 42 days postvaccination
General disorders Injection-Site Pain	27.8% 50/180 • Number of events 51 • Up to 42 days postvaccination
General disorders Injection-Site Swelling	37.8% 68/180 • Number of events 68 • Up to 42 days postvaccination

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.
Publication restrictions are in place

Restriction type: OTHER