Phase 3
N=150
Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)
Varicella
Bottom Line
View on ClinicalTrials.gov: NCT03843632 ↗Enrolled (actual)
150
Serious AEs
0.7%
Results posted
Apr 2021
Primary outcome: Primary: Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline — 100.0; 100.0; 95.5; 100.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VARIVAX™ (Biological)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline |
100.0; 100.0; 95.5; 100.0 | — |
| PRIMARY Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline |
70.7; 78.6; 11.3; 13.9 | — |
| PRIMARY VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline |
100.0; 100.0; 95.5; 100.0 | — |
| PRIMARY GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline |
71.1; 13.4; 24.8; 4.2; 216.7; 151.7 | — |
| PRIMARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline |
3.0; 11.3; 5.0; 11.2 | — |
| PRIMARY Percentage of Participants With ≥4-Fold Rise in Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination Among Participants Who Were Seropositive at Baseline |
60.9; 66.7; 54.5; 100.0 | — |
| SECONDARY Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1 |
16.0; 3.3; 3.0; 0.0; 40.0; 23.3 | — |
| SECONDARY Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2 |
18.4; 0; 49.0; 23.3; 8.2; 3.3 | — |
| SECONDARY Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1 |
2.0; 3.3; 0.0; 5.4 | — |
| SECONDARY Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2 |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Elevated Temperature Post-Vaccination 1 |
2.0; 0.0; 3.0; 8.1 | — |
| SECONDARY Percentage of Participants With Elevated Temperature Post-Vaccination 2 |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1 |
6.0; 0.0; 6.1; 2.7; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2 |
2.0; 0.0 | — |
| SECONDARY Percentage of Participants With Systemic AEs Post-Vaccination 1 |
38.0; 23.3; 36.4; 43.2 | — |
| SECONDARY Percentage of Participants With Systemic AEs Post-Vaccination 2 |
28.6; 26.7 | — |
| SECONDARY Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2 |
0.0; 0.0; 3.0; 0.0 | — |
| SECONDARY Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2 |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2 |
0.0; 0.0; 0.0; 0.0 | — |
Summary
The purpose of this study was to evaluate the immunogenicity and safety of VARIVAX™ vaccine in healthy Russian children, adolescents, and adults. No formal hypothesis was tested.
Eligibility Criteria
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 until 3 months following last study vaccination
- females not of reproductive potential do not require a pregnancy test or use of contraceptives
- legal representative of adult or parent of children understands risks involved with, consent to participate in, and comply with the study procedures
Exclusion Criteria
- has a history of allergy or anaphylactic reaction to neomycin, gelatin, or any component of VARIVAX^TM
- has received any form of varicella or herpes zoster vaccine at any time prior to study, or anticipates receiving any during study
- has received immune globulin, a blood transfusion or blood derived products within prior 5 months or plans to do so during study
- has received aspirin or any aspirin-containing products within prior 14 days
- has been exposed to varicella or herpes zoster in the prior 4 weeks involving playmate, hospital or continuous household contact, or had contact with a newborn whose mother had chickenpox 5 days before or 2 days after delivery
- has, or lives with a person who has, any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity including those resulting from corticosteroid use or other immunosuppressive therapy
- has received glucocorticosteroids for more than 5 consecutive days within prior 3 months, or any dose of glucocorticoids within prior 7 days, or expects to use glucocorticosteroids during the study
- was vaccinated with licensed non-live or live vaccine within prior 30 days or expects vaccination during 42 day follow-up postvaccination period
- had a fever within 72 hours prior to study vaccination
- has participated in another trial within prior 30 days, is currently participating in another trial, or plans to participate in another trial during the planned study period for this trial
- is pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT03843632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.