Trial Outcomes & Findings for Zostavax® at Minimum Release Specification Approaching Expiry (V211-044) (NCT NCT00681031)

Results Overview

Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

96 participants

Primary outcome timeframe

Predose (Day 0) and Day 28-35 Post Dose

Results posted on

2021-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	All Enrolled Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
Overall Study STARTED	96
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled n=96 Participants Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
Age, Continuous	62.2 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose (Day 0) and Day 28-35 Post Dose

Population: All vaccinated participants excluding those with any protocol deviation which may have interfered with the immunogenicity evaluation and excluding participants with herpes zoster onset before the post-vaccination blood sample

Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).

Outcome measures

Outcome measures
Measure	All Enrolled n=92 Participants Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
Geometric Mean Titre (GMT) of Varicella Antibodies Predose	215.8 gpELISA units/mL Interval 178.1 to 261.4
Geometric Mean Titre (GMT) of Varicella Antibodies Postdose	674.0 gpELISA units/mL Interval 565.4 to 803.5

Adverse Events

V211

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	V211 n=96 participants at risk All enrolled participants who received vaccination
General disorders Injection site erythema	37.5% 36/96 • Number of events 36 • Up to 35 days post vaccination
General disorders Injection site pain	40.6% 39/96 • Number of events 39 • Up to 35 days post vaccination
General disorders Injection site swelling	21.9% 21/96 • Number of events 21 • Up to 35 days post vaccination

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 investigator shall send to Sanofi Pasteur MSD for approval any of the publication and/or communication draft, in whatever forms (abstracts, manuscripts, texts). Sanofi Pasteur MSD shall have 60 (sixty) days to review the draft, have reserves if any, and formulate its refusal to the draft in whole or in part if the draft contains confidential data, may prejudice to Sanofi Pasteur MSD patent/intellectual property rights and/or is not compliant with the study results.
Publication restrictions are in place

Restriction type: OTHER