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VARIVAX · 1 trial · 1 indication
VZV antibody titers were measured using a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The VZV antibody response rate was defined as the percentage of participants with a post-vaccination VZV antibody titer ≥5 gpELISA units/mL for participants whose baseline VZV antibody titer was \<1.25 gpELISA units/mL. VZV antibody response rate was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
VZV antibody levels were measured using a gpELISA. The VZW antibody seroconversion rate was defined as the percentage of participants with VZV antibodies ≥1.25 gpELISA units/mL in participants with a baseline VZV antibody titer \<1.25 gpELISA units/mL. VZW antibody seroconversion was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, confidence intervals (CIs) were only calculated when there were at least 5 participants who were seropositive in a treatment group.
GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the GMFR was calculated as the ratio of the VZV GMT at 6 weeks post last vaccination to the VZV GMT at Day 1 (baseline). The GMFR from Day 1 was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group.
GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the percentage of participants with a ≥4-fold rise in VZV antibody titer from Day 1 (baseline) to post-vaccination was assessed and reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents). Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group.
| Arm | Type | Description |
|---|---|---|
| VARIVAX™ | EXPERIMENTAL | All participants will receive one dose subcutaneous (SC) VARIVAX™ on Day 1. Adult participants and adolescent participants 13 years and older will also receive a second SC dose VARIVAX™ on Day 43. |
| Name | Type | Description |
|---|---|---|
| VARIVAX™ | BIOLOGICAL | VARIVAX™ administered by SC injection as 0.5 mL Varicella Virus Vaccine Live in sterile suspension on Day 1 (all participants) and Day 43 (adult and adolescent participants). |
Inclusion Criteria: * has a negative clinical history for varicella and herpes zoster * females of reproductive potential have a negative pregnancy test prior to each study vaccination * females of reproductive potential remain abstinent or use 2 acceptable methods of birth control during study unt...
Varivax is a vaccine used for the prevention of varicella, commonly known as chickenpox. It is also studied in the context of measles, mumps, rubella, and varicella combination vaccines. Varivax is developed by Merck & Company, Inc. and is currently in Phase 3 clinical development.
Varivax is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting Phase 3 clinical trials for Varivax in healthy children and adults to evaluate its safety and immunogenicity.
Varivax is in Phase 3 clinical development. It has completed three Phase 3 trials, including studies in healthy children and healthy Russian adults. The drug is investigational and not yet approved for use.
Varivax has been studied in three completed Phase 3 trials: NCT00975507, NCT00985153, and NCT03843632. These trials evaluated the safety and immunogenicity of Varivax in healthy children and adults, with a total enrollment of 4,407 participants.
Varivax is a standalone varicella vaccine, while ProQuad is a combination vaccine that includes measles, mumps, rubella, and varicella. In clinical trials, Varivax was compared against ProQuad and M-M-R II to assess immunogenicity and safety in healthy children.