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Also known as ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
ZOSTAVAX Full Dose · 1 trial · 1 indication
VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.
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.
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention
The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.
Systemic AEs included all reported AEs except injection-site AEs
Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.
| Arm | Type | Description |
|---|---|---|
| Full Dose Subcutaneous | ACTIVE_COMPARATOR | Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. |
| 1/3 Dose Subcutaneous | EXPERIMENTAL | Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. |
| Full Dose Intradermal | EXPERIMENTAL | Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. |
| 1/3 Dose Intradermal | EXPERIMENTAL | Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. |
| 1/10 Dose Intradermal | EXPERIMENTAL | Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. |
| 1/27 Dose Intradermal | EXPERIMENTAL | Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. |
| Name | Type | Description |
|---|---|---|
| ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous | BIOLOGICAL | One 0.65 mL injection subcutaneously on Day 1 |
| ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous | BIOLOGICAL | One approximately 0.22 mL injection subcutaneously on Day 1 |
| ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal | BIOLOGICAL | Two intradermal injections of approximately 0.15 mL each on Day 1 |
| ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal | BIOLOGICAL | One intradermal injection of approximately 0.1 mL on Day 1 |
| Full Dose Intradermal Placebo | BIOLOGICAL | Two intradermal placebo injections of approximately 0.15 mL each on Day 1 |
| Intradermal Placebo | BIOLOGICAL | One intradermal placebo injection of approximately 0.1 mL on Day 1 |
Inclusion Criteria: * Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years * Temperature less than 100.4 °F on day of vaccination * Female participants of reproductive potential must have a negative pregnancy test and ...
ZOSTAVAX Full Dose is a vaccine being studied for the prevention of herpes zoster, also known as shingles. It is a live zoster vaccine developed by Merck & Company, Inc. (ticker: MRK). The full dose formulation is administered subcutaneously and is also known as ZOSTAVAX (Zoster Vaccine Live) Full Dose Subcutaneous.
ZOSTAVAX Full Dose is being studied for use in herpes zoster, the viral infection that causes shingles. The clinical trial for this vaccine enrolled adults aged 50 years and older, including healthy volunteers. It is an investigational product and has not been approved for this use.
ZOSTAVAX Full Dose is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the clinical trial evaluating this vaccine candidate for herpes zoster.
ZOSTAVAX Full Dose is in Phase 1 clinical development. The only listed trial for this vaccine is a completed Phase 1 study. It is an investigational product and is not approved by the FDA for the studied indication.
ZOSTAVAX Full Dose has been evaluated in one clinical trial, NCT01385566, titled "A Study of Intradermal Administration of ZOSTAVAX (V211-051 AM2)." This Phase 1 trial was completed and enrolled 223 participants with herpes zoster. It was randomized and active-controlled, with no double-blinding.
Yes, ZOSTAVAX Full Dose is also known as ZOSTAVAX (Zoster Vaccine Live) Full Dose Subcutaneous. Both names refer to the same vaccine candidate developed by Merck for herpes zoster. The full dose is administered subcutaneously.