A Phase 3 interventional study of Zoster Vaccine, Live (AMP) and Zoster Vaccine, Live in Herpes Zoster and Shingles, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention
This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's enrollment of 498 is above the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ZOSTAVAX™ manufactured with an alternative process
Biological: Zoster Vaccine, Live (AMP)
ZOSTAVAX™ manufactured with the current process
Biological: Zoster Vaccine, Live
One approximately 0.65-mL injection subcutaneously on Day 1
One approximately 0.65-mL injection subcutaneously on Day 1
Also known as: ZOSTAVAX™, V211
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Time frame: Day 1 and Week 6 postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
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).
Time frame: Day 1 (Baseline) to Week 6 postvaccination
Number of Participants With One or More Adverse Experiences (AEs)
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.
Time frame: Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination
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
Time frame: Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination
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
Time frame: Day 1 to Day 182 postvaccination
| Milestone | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Started | 332 | 166 |
| Vaccinated | 331 | 166 |
| Completed | 329 | 166 |
| Not completed | 3 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Started | 329 | 166 |
| Completed | 328 | 163 |
| Not completed | 1 | 3 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 2 |
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
| Units/mL | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Day 1 postvaccination; n = 330, 166 | 235.7 (211.7 to 262.5) | 208.2 (176.4 to 245.7) |
| Week 6 postvaccination; n = 320, 164 | 532.6 (489.2 to 579.9) | 457.1 (403.3 to 518.0) |
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).
| Ratio | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers | 2.3 (2.1 to 2.4) | 2.2 (2.0 to 2.5) |
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.
| Participants | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Number of Participants With One or More Adverse Experiences (AEs) | 205 | 99 |
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
| Participants | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination | 1 | 2 |
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
| Participants | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination | 4 | 8 |
Collected over Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZOSTAVAX™ (AMP) | — | 4/330 (1.2%) | 186/330 (56.4%) |
| ZOSTAVAX™ | — | 8/166 (4.8%) | 85/166 (51.2%) |
| Event | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Bile duct stoneHepatobiliary disorders | 0/330 | 1/166 |
| Traumatic liver injuryInjury, poisoning and procedural complications | 0/330 | 1/166 |
| Cardiac failure congestiveCardiac disorders | 0/330 | 1/166 |
| VertigoEar and labyrinth disorders | 0/330 | 1/166 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/330 | 1/166 |
| Ileus paralyticGastrointestinal disorders | 0/330 | 1/166 |
| CholangitisHepatobiliary disorders | 0/330 | 1/166 |
| Gallbladder perforationHepatobiliary disorders | 0/330 | 1/166 |
| Enterocolitis infectiousInfections and infestations | 0/330 | 1/166 |
| ConcussionInjury, poisoning and procedural complications | 0/330 | 1/166 |
| Event | ZOSTAVAX™ (AMP) | ZOSTAVAX™ |
|---|---|---|
| Injection-site painGeneral disorders | 146/330 | 68/166 |
| Injection-site erythemaGeneral disorders | 135/330 | 66/166 |
| Injection-site swellingGeneral disorders | 106/330 | 53/166 |
| Injection-site pruritusGeneral disorders | 22/330 | 13/166 |
| Age, Continuous(years) | ZOSTAVAX™ (AMP) | ZOSTAVAX™ | Total |
|---|---|---|---|
| Mean | 62.9 ± 7.1 | 62.4 ± 7.0 | 62.8 ± 7.1 |
| Sex: Female, Male(Participants) | ZOSTAVAX™ (AMP) | ZOSTAVAX™ | Total |
|---|---|---|---|
| Female | 196 | 99 | 295 |
| Male | 136 | 67 | 203 |
No study locations are listed for this record.
Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC