Phase 3
N=611
Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
Varicella
Bottom Line
View on ClinicalTrials.gov: NCT02062502 ↗Enrolled (actual)
611
Serious AEs
2.6%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL — 97.2; 97.2 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VARIVAX™ New Seed Process (Biological); VARIVAX™ 2007 process (Biological); M-M-R II™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL |
97.2; 97.2 | <0.001 sig |
| PRIMARY Geometric Mean Titer of VZV Antibodies |
16.28; 17.2 | <0.001 sig |
| SECONDARY Percentage of Participants With Fever (>=102.2 °F Oral Equivalent) |
9.5; 10.5; 8.1; 8.6 | — |
| SECONDARY Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1 |
0.3; 2.4; 0.0; 0.0; 0.0; 0.3 | — |
| SECONDARY Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2 |
0.0; 0.0; 0.0; 0.0; 0.4; 0.0 | — |
| SECONDARY Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1 |
20.3; 19.8; 10.0; 10.6; 29.9; 28.0 | — |
| SECONDARY Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2 |
20.6; 22.5; 16.2; 12.0; 22.4; 24.3 | — |
Summary
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.
Eligibility Criteria
Inclusion Criteria
- Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella
Exclusion Criteria
- Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
- Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
- Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study
- History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™
- Received salicylates within 14 days prior to study vaccination
- Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
- Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
- History of seizure disorder, including febrile seizure
- Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination
- History of thrombocytopenia
- Born to a human immunodeficiency virus (HIV)-infected mother
- Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT02062502). 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.