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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_579 |
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A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat treated VZV vaccine V212 or with Zostavax™.
The enrollment of participants into this study was conducted in 2 parts, Part A and Part B. The first 42 eligible participants were enrolled into Part A of the study. In Part A, the reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners performing the reading at each timepoint; all subsequent skin test readings in Part A were performed at 48 hours post administration. After all skin test reactions were obtained at baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the frequency of baseline negative skin tests in order to confirm that the planned sample size (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours (post administration) in order to determine the preferred time for evaluation of the skin test reaction.
The interim analysis from Part A confirmed the study sample size, an additional 78 subjects were enrolled into Part B to achieve the planned sample size (N=120). The study procedures for Part B of the study were identical to those in Part A with the following exceptions: (1) baseline skin test readings were performed only once, at either 48 or 72 hours (post administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was needed for the skin test reading at baseline.
All eligible participants, regardless of treatment group, were administered three injections of the varicella antigen (VZV Skin Test reagent), once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination. Reactions to the skin test were assessed by the same examiner for each participant to the greatest extent possible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V212 | Experimental | Participants randomized to receive V212 (heat treated VZV Vaccine) |
|
| Zostavax™ | Active Comparator | Participants randomized to receive Zostavax™ (Zoster Vaccine, live) |
|
| Placebo | Placebo Comparator | Participants randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V212 | Biological | Two doses of 0.65 mL V212 subcutaneous injection administered at Day 1 and Day 31 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Negative VZV Skin Test at Baseline (Part A) | Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were considered to have a negative baseline skin test. | 48 hours following administration of the baseline skin test |
| Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B) | Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination. For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring >= 5mm for the VZV antigen was considered a positive skin test. | 48-72 hours after administration of skin test at 14-17 days postdose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| VZV Skin Test Reactions at 48 and 72 Hours (Part A) | Prior to vaccination, participants were administered a baseline VZV skin test for which the skin test reagent and saline were injected in opposite arms. The skin reaction (erythema and induration) around the injection site was assessed at 48 hours and at 72 hours. The reaction was marked with a ball point pen and the longest dimension closest to 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were defined as having a negative baseline skin test; and a measure of >= 5mm for the VZV antigen were defined as having a positive skin test. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Negative Reaction for Saline at Baseline (Part A) | Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms. The skin reaction (erythema and induration) to saline was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline had a negative reaction for saline, and measure >= 5mm for saline had a positive reaction for saline at baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37781954 | Derived | de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5. |
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In Part A, 42 participants received a baseline VZV Skin Test which was evaluated 48 and 72 post administration, and these participants were included in the analysis for Part B. All Participants were randomized to receive V212, Zostavax™ or placebo.
The study was performed in 2 parts - Part A and Part B, with a total of 120 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | V212 | Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine) administered at Day 1 and Day 31. |
| FG001 | Zostavax™ | Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31. |
| FG002 | Placebo | Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | V212 | Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine) administered at Day 1 and Day 31. |
| BG001 | Zostavax™ | Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | Number of Participants With a Negative Reaction for Saline at Baseline (Part A) | Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms. The skin reaction (erythema and induration) to saline was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline had a negative reaction for saline, and measure >= 5mm for saline had a positive reaction for saline at baseline. | 42 participants enrolled in Part A | Posted | Number | Participants | 48 hours following administration of the baseline skin test |
|
1-28 days post any vaccine dose
The analyzed population includes all vaccinated participants. One participant in the placebo group was not vaccinated and is not included in the analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V212 | Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine) administered at Day 1 and Day 31. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (12.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| Comparator: Zostavax™ | Biological | Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31 |
|
|
| Comparator: Placebo | Biological | Two doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31 |
|
| VZV Skin Test | Other | Three intradermal injections of the 0.1 ml varicella antigen (VZV Skin Test reagent) were administered, once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination. |
|
| Saline | Other | One intradermal injection of the 0.1 ml saline was administered at the time of the baseline VZV skin test prior to the first vaccination. Saline and VZV skin test reagents were administered on opposite arms. |
|
| 48 hours and 72 hours post administration of baseline skin test |
| Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B) | The number of participants with all serious and nonserious adverse events, and vaccine-related serious and nonserious adverse events, from 1-28 days post any vaccination dose was determined to assess safety. Non serious adverse events include injection-site adverse events as well as systemic adverse events post vaccination. Vaccine-related events include all events that were possibly, probably or definitely related to the vaccine according to the investigator. Participants with injection site adverse events due to administration of VZV skin tests are not included. | 1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2 |
| Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B) | The number of participants with injection site adverse events due to the VZV skin test after administration of the VZV skin test antigen. | 1-5 days post administration of each VZV skin test |
| 48 hours following administration of the baseline skin test |
| Subject withdrew consent (Part A) |
|
| BG002 | Placebo | Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants With a Negative VZV Skin Test at Baseline (Part A) | Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were considered to have a negative baseline skin test. | Participants enrolled in Part A with a negative reaction for saline. | Posted | Number | Participants | 48 hours following administration of the baseline skin test |
|
|
|
| Secondary | VZV Skin Test Reactions at 48 and 72 Hours (Part A) | Prior to vaccination, participants were administered a baseline VZV skin test for which the skin test reagent and saline were injected in opposite arms. The skin reaction (erythema and induration) around the injection site was assessed at 48 hours and at 72 hours. The reaction was marked with a ball point pen and the longest dimension closest to 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were defined as having a negative baseline skin test; and a measure of >= 5mm for the VZV antigen were defined as having a positive skin test. | 42 participants enrolled in Part A | Posted | Number | Participants | 48 hours and 72 hours post administration of baseline skin test |
|
|
|
|
| Secondary | Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B) | The number of participants with all serious and nonserious adverse events, and vaccine-related serious and nonserious adverse events, from 1-28 days post any vaccination dose was determined to assess safety. Non serious adverse events include injection-site adverse events as well as systemic adverse events post vaccination. Vaccine-related events include all events that were possibly, probably or definitely related to the vaccine according to the investigator. Participants with injection site adverse events due to administration of VZV skin tests are not included. | Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis. | Posted | Number | Participants | 1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2 |
|
|
|
| Primary | Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B) | Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination. For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring >= 5mm for the VZV antigen was considered a positive skin test. | Per protocol population - participants with a negative baseline VZV Skin Test (<5 mm skin reaction to both, saline and the VZV skin test reagent), and who did not have a protocol deviation that could interfere with the immune response to vaccine following two administrations of either ZOSTAVAX™, placebo, or V212 | Posted | Number | Participants | 48-72 hours after administration of skin test at 14-17 days postdose 2 |
|
|
|
|
| Secondary | Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B) | The number of participants with injection site adverse events due to the VZV skin test after administration of the VZV skin test antigen. | Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis. | Posted | Number | Participants | 1-5 days post administration of each VZV skin test |
|
|
|
| 0 |
| 41 |
| 36 |
| 41 |
| EG001 | Zostavax™ | Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31. | 0 | 39 | 36 | 39 |
| EG002 | Placebo | Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31. | 0 | 39 | 29 | 39 |
| Injection site erythema (Vaccination) | General disorders | MedDRA (12.1) | Injection site reaction following administration of V212, Zostavax™ or placebo. |
|
| Injection site erythema (Skin test) | General disorders | MedDRA (12.1) | Injection site reaction following administration of the skin test. |
|
| Injection site induration (Vaccination) | General disorders | MedDRA (12.1) | Injection site reaction following administration of V212, Zostavax™ or placebo. |
|
| Injection site induration (Skin test) | General disorders | MedDRA (12.1) | Injection site reaction following administration of the skin test. |
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| Injection site pain (Vaccination) | General disorders | MedDRA (12.1) | Injection site reaction following administration of V212, Zostavax™ or placebo. |
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| Injection site pain (Skin test) | General disorders | MedDRA (12.1) | Injection site reaction following administration of the skin test. |
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| Injection site pruritis (Vaccination) | General disorders | MedDRA (12.1) | Injection site reaction following administration of V212, Zostavax™ or placebo. |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA (12.1) |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) |
|
For multicenter studies, an investigator and his/her colleagues may publish their data independently subsequent to the multicenter publication. 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. SPONSOR review can be expedited to meet publication timelines.
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| One or more injection-site AE |
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| One or more systemic AE |
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| One or more vaccine-related (VR) AE |
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| One or more VR injection-site AE |
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| One or more VR systemic AE |
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| One or more SAE |
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| One or more VR SAE |
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