Phase 3
N=600
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
Varicella
Bottom Line
View on ClinicalTrials.gov: NCT03239873 ↗Enrolled (actual)
600
Serious AEs
2.0%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL — 98.4; 98.3 Percentage of Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VARIVAX® PE34 Process (Biological); VARIVAX® 2016 Commercial Process (Biological); M-M-R II® (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL |
98.4; 98.3 | <0.001 sig |
| PRIMARY Geometric Mean Titer of VZV Antibodies |
18.5; 19.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Fever (≥102.2 °F Oral Equivalent) |
11.8; 9.8; 8.9; 6.1 | 0.436 |
| SECONDARY Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%) |
0.3; 1.7; 0.3; 0.0; 2.7; 1.3 | 0.102 |
| SECONDARY Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%) |
1.4; 0.4; 0.4; 0.7; 0.4; 0.0 | 0.170 |
| SECONDARY Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1 |
9.7; 10.7; 13.4; 12.7; 3.0; 5.7 | 0.696 |
| SECONDARY Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2 |
19.6; 19.9; 8.7; 10.3; 10.1; 8.2 | 0.931 |
| SECONDARY Percentage of Participants With One or More Adverse Events |
90.0; 88.3 | — |
| SECONDARY Percentage of Participants With One or More Serious Adverse Events |
2.0; 2.0 | — |
| SECONDARY Percentage of Participants With One or More Vaccine-Related Adverse Events |
56.2; 54.3 | — |
| SECONDARY Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4) |
76.6; 74.3 | — |
| SECONDARY Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0) |
60.9; 59.9 | — |
| SECONDARY Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL) |
100.0; 97.5 | — |
| SECONDARY Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody |
6.5; 7.2 | — |
| SECONDARY Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody |
80.6; 82.5 | — |
| SECONDARY Percentage of Participants With One or More Vaccine-Related Serious Adverse Events |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Discontinued From the Study Due to an Adverse Event |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%) |
8.0; 9.3 | — |
| SECONDARY Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%) |
1.4; 2.1 | — |
| SECONDARY Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%) |
29.5; 26.6 | — |
Summary
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial 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® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process, and that antibody response rate induced by VARIVAX® PE34 Process 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®
- Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
- 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
- Has a diagnosis of active untreated tuberculosis
- Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT03239873). 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.