Trial Outcomes & Findings for A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED) (NCT NCT00130793)

Last Updated: 2015-01-26

Results Overview

The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

368 participants

Primary outcome timeframe

4 weeks

Results posted on

2015-01-26

Participant Flow

Patients were recruited at 14 sites in the United States. First patient randomized: 08Aug2005; Last patient last visit: 28Nov2005

Participant milestones

Participant milestones
Measure	ZOSTAVAX™ With PGSU ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection	ZOSTAVAX™ With PGS ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection
Overall Study STARTED	183	185
Overall Study Vaccinated	182	185
Overall Study COMPLETED	180	181
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	ZOSTAVAX™ With PGSU ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection	ZOSTAVAX™ With PGS ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection
Overall Study Lost to Follow-up	1	4
Overall Study Withdrew consent	2	0

Baseline Characteristics

A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZOSTAVAX™ With PGSU n=182 Participants ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection	ZOSTAVAX™ With PGS n=185 Participants ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection	Total n=367 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 9.25 • n=5 Participants	63.2 years STANDARD_DEVIATION 8.44 • n=7 Participants	63.35 years STANDARD_DEVIATION 8.83 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	106 Participants n=7 Participants	203 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	79 Participants n=7 Participants	164 Participants n=5 Participants
Race/Ethnicity Asian	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity Asiatic	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity Black	19 participants n=5 Participants	15 participants n=7 Participants	34 participants n=5 Participants
Race/Ethnicity Hispanic American	30 participants n=5 Participants	34 participants n=7 Participants	64 participants n=5 Participants
Race/Ethnicity Indian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity Native American	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity White	124 participants n=5 Participants	126 participants n=7 Participants	250 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)

Outcome measures

Outcome measures
Measure	ZOSTAVAX™ With PGSU n=176 Participants ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection	ZOSTAVAX™ With PGS n=178 Participants ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination	717.5 gpELISA units/mL Interval 607.3 to 847.7	844.9 gpELISA units/mL Interval 704.4 to 1013.6

SECONDARY outcome

Timeframe: 4 weeks

Population: All vaccinated subjects with safety follow-up are included.

Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

Outcome measures

Outcome measures
Measure	ZOSTAVAX™ With PGSU n=180 Participants ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection	ZOSTAVAX™ With PGS n=183 Participants ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection
Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination With vaccine related SAEs	0 Participants	0 Participants
Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination Without vaccine related SAEs	180 Participants	183 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From prevaccination (baseline) to 4 weeks postvaccination

GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination

Outcome measures

Outcome measures
Measure	ZOSTAVAX™ With PGSU n=174 Participants ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection	ZOSTAVAX™ With PGS n=177 Participants ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination	2.6 gpELISA units/mL Interval 2.2 to 3.0	2.9 gpELISA units/mL Interval 2.4 to 3.4

Adverse Events

ZOSTAVAX™ With PGSU

Serious events: 1 serious events

Other events: 63 other events

Deaths: 0 deaths

ZOSTAVAX™ With PGS

Serious events: 0 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ZOSTAVAX™ With PGSU n=180 participants at risk ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection	ZOSTAVAX™ With PGS n=183 participants at risk ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection
Infections and infestations Gastroenteritis	0.56% 1/180 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.	0.00% 0/183 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.

Other adverse events

Other adverse events
Measure	ZOSTAVAX™ With PGSU n=180 participants at risk ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection	ZOSTAVAX™ With PGS n=183 participants at risk ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection
General disorders Injection site erythema	28.9% 52/180 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.	35.5% 65/183 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.
General disorders Injection site pain	26.7% 48/180 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.	38.3% 70/183 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.
General disorders Injection site pruritus	7.2% 13/180 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.	8.7% 16/183 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.
General disorders Injection site swelling	24.4% 44/180 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.	32.8% 60/183 • Through 28 days post-vaccination. The AE presentation includes participants who were vaccinated and had safety follow-up.

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 Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER