Trial Outcomes & Findings for A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014) (NCT NCT00322231)
NCT ID: NCT00322231
Last Updated: 2015-01-26
Results Overview
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
To Day 28 postvaccination
Results posted on
2015-01-26
Participant Flow
Patients were recruited at 9 sites in the United States. First patient enrolled: May-2006; Last patient last visit: July - 2007
Participant milestones
| Measure |
ZOSTAVAX™ / Placebo
0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
|
Placebo / ZOSTAVAX™
0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
|
|---|---|---|
|
Period 1
STARTED
|
51
|
50
|
|
Period 1
COMPLETED
|
51
|
50
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
51
|
49
|
|
Period 2
COMPLETED
|
51
|
49
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
Baseline characteristics by cohort
| Measure |
ZOSTAVAX™ / Placebo
n=51 Participants
0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
|
Placebo / ZOSTAVAX™
n=50 Participants
0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50 to 59 Years of age
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Age, Customized
≥ 60 Years of age
|
41 participants
n=5 Participants
|
40 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic American
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 participants
n=5 Participants
|
42 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: To Day 28 postvaccinationPopulation: All vaccinated participants were evaluated for safety. This was a crossover study. All participants received one dose each of ZOSTAVAX™ and placebo. Data below reflect SAEs reported after receipt of ZOSTAVAX™ or placebo.
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
Outcome measures
| Measure |
ZOSTAVAX™
n=100 Participants
Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
|
Placebo
n=101 Participants
Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
|
|---|---|---|
|
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
|
100 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: 4 weeks postvaccinationPopulation: Per-protocol population
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Outcome measures
| Measure |
ZOSTAVAX™
n=100 Participants
Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
|
Placebo
n=50 Participants
Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
|
810.1 gpELISA units/mL
Interval 688.3 to 953.4
|
391.1 gpELISA units/mL
Interval 291.9 to 523.9
|
SECONDARY outcome
Timeframe: From prevaccination (baseline) to 4 weeks postvaccinationPopulation: Per-protocol population
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
Outcome measures
| Measure |
ZOSTAVAX™
n=95 Participants
Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
|
Placebo
n=45 Participants
Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
|
2.1 Geometric mean fold rise
Interval 1.8 to 2.4
|
1.0 Geometric mean fold rise
Interval 0.9 to 1.1
|
Adverse Events
ZOSTAVAX™
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ZOSTAVAX™
n=98 participants at risk
All participants that received ZOSTAVAX™ from both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group. Two participants that received ZOSTAVAX™ were lost to follow up and not included in the analysis.
|
Placebo
n=96 participants at risk
All participants that received Placebo in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™. Five participants that received placebo were lost to follow up and not included in the analysis.
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
33.7%
33/98 • Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period. The participants at risk are ITT population with follow-up.
|
3.1%
3/96 • Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period. The participants at risk are ITT population with follow-up.
|
|
General disorders
Injection Site Pain
|
36.7%
36/98 • Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period. The participants at risk are ITT population with follow-up.
|
1.0%
1/96 • Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period. The participants at risk are ITT population with follow-up.
|
|
General disorders
Injection Site Pruritus
|
5.1%
5/98 • Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period. The participants at risk are ITT population with follow-up.
|
0.00%
0/96 • Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period. The participants at risk are ITT population with follow-up.
|
|
General disorders
Injection Site Swelling
|
26.5%
26/98 • Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period. The participants at risk are ITT population with follow-up.
|
2.1%
2/96 • Day 1 - 28 following each vaccination
Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period. The participants at risk are ITT population with 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