Trial Outcomes & Findings for Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1) (NCT NCT01505647)
NCT ID: NCT01505647
Last Updated: 2017-04-12
Results Overview
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
498 participants
Primary outcome timeframe
Day 1 and Week 6 postvaccination
Results posted on
2017-04-12
Participant Flow
One participant in the ZOSTAVAX™ (AMP) group was randomized but not vaccinated, making the number of participants vaccinated in this group 331
Participant milestones
| Measure |
ZOSTAVAX™ (AMP)
Zoster Vaccine, Live Alternative Manufacturing Process (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
Day 1 Through Day 42 Follow-up
STARTED
|
332
|
166
|
|
Day 1 Through Day 42 Follow-up
Vaccinated
|
331
|
166
|
|
Day 1 Through Day 42 Follow-up
COMPLETED
|
329
|
166
|
|
Day 1 Through Day 42 Follow-up
NOT COMPLETED
|
3
|
0
|
|
Day 43 Through Day 182 Follow-up
STARTED
|
329
|
166
|
|
Day 43 Through Day 182 Follow-up
COMPLETED
|
328
|
163
|
|
Day 43 Through Day 182 Follow-up
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
ZOSTAVAX™ (AMP)
Zoster Vaccine, Live Alternative Manufacturing Process (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
Day 1 Through Day 42 Follow-up
Lost to Follow-up
|
1
|
0
|
|
Day 1 Through Day 42 Follow-up
Physician Decision
|
1
|
0
|
|
Day 1 Through Day 42 Follow-up
Withdrawal by Subject
|
1
|
0
|
|
Day 43 Through Day 182 Follow-up
Death
|
0
|
1
|
|
Day 43 Through Day 182 Follow-up
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
Baseline characteristics by cohort
| Measure |
ZOSTAVAX™ (AMP)
n=332 Participants
Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
n=166 Participants
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
Total
n=498 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Week 6 postvaccinationPopulation: Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Outcome measures
| Measure |
ZOSTAVAX™ (AMP)
n=330 Participants
Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
n=166 Participants
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
Day 1 postvaccination; n = 330, 166
|
235.7 Units/mL
Interval 211.7 to 262.5
|
208.2 Units/mL
Interval 176.4 to 245.7
|
|
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
Week 6 postvaccination; n = 320, 164
|
532.6 Units/mL
Interval 489.2 to 579.9
|
457.1 Units/mL
Interval 403.3 to 518.0
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) to Week 6 postvaccinationPopulation: Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster.
VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).
Outcome measures
| Measure |
ZOSTAVAX™ (AMP)
n=320 Participants
Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
n=164 Participants
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
|
2.3 Ratio
Interval 2.1 to 2.4
|
2.2 Ratio
Interval 2.0 to 2.5
|
SECONDARY outcome
Timeframe: Day 1 to Day 42 postvaccinationPopulation: Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the 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
| Measure |
ZOSTAVAX™ (AMP)
n=330 Participants
Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
n=166 Participants
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
Number of Participants With One or More Adverse Experiences (AEs)
|
205 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 42 postvaccinationPopulation: Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.
An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement
Outcome measures
| Measure |
ZOSTAVAX™ (AMP)
n=330 Participants
Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
n=166 Participants
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 182 postvaccinationPopulation: Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.
An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement
Outcome measures
| Measure |
ZOSTAVAX™ (AMP)
n=330 Participants
Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
n=166 Participants
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination
|
4 Participants
|
8 Participants
|
Adverse Events
ZOSTAVAX™ (AMP)
Serious events: 4 serious events
Other events: 186 other events
Deaths: 0 deaths
ZOSTAVAX™
Serious events: 8 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZOSTAVAX™ (AMP)
n=330 participants at risk
Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
n=166 participants at risk
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Psychiatric disorders
Psychotic disorder
|
0.30%
1/330 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.00%
0/166 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.30%
1/330 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.00%
0/166 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.30%
1/330 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.00%
0/166 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.30%
1/330 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.00%
0/166 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Psychiatric disorders
Depression
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/330 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.60%
1/166 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
1/330 • Number of events 1 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
0.00%
0/166 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
Other adverse events
| Measure |
ZOSTAVAX™ (AMP)
n=330 participants at risk
Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
|
ZOSTAVAX™
n=166 participants at risk
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|---|---|---|
|
General disorders
Injection-site erythema
|
40.9%
135/330 • Number of events 138 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
39.8%
66/166 • Number of events 68 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
General disorders
Injection-site pain
|
44.2%
146/330 • Number of events 153 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
41.0%
68/166 • Number of events 69 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
General disorders
Injection-site pruritus
|
6.7%
22/330 • Number of events 23 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
7.8%
13/166 • Number of events 15 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
|
General disorders
Injection-site swelling
|
32.1%
106/330 • Number of events 107 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination
|
31.9%
53/166 • Number of events 56 • Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 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