Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
Public ClinicalTrials.gov record NCT03239873. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantly With M-M-R™ II
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03239873
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Interventions
- VARIVAX® PE34 Process Biological
- VARIVAX® 2016 Commercial Process Biological
- M-M-R II® Biological
Biological
Eligibility (public fields only)
- Age range
- 12 Months to 23 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 17, 2017 (Actual)
- Primary completion
- Aug 14, 2018 (Actual)
- Completion
- Apr 2, 2019 (Actual)
- Last update posted
- Jan 27, 2021
2017 – 2019
United States locations
- U.S. sites
- 37
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics ( Site 0018) | Birmingham | Alabama | 35205 | — |
| Children's Clinic of Jonesboro, PA ( Site 0030) | Jonesboro | Arkansas | 72401 | — |
| Southland Clinical Research Center ( Site 0017) | Anaheim | California | 92804 | — |
| Premier Health Research Center, LLC ( Site 0044) | Downey | California | 90240 | — |
| California Research Foundation ( Site 0003) | San Diego | California | 92123 | — |
| IMMUNOe Research Centers ( Site 0046) | Thornton | Colorado | 80233 | — |
| Children's Research at Altamonte Pediatric Associates ( Site 0040) | Lake Mary | Florida | 32746 | — |
| University of South Florida ( Site 0042) | Tampa | Florida | 33606 | — |
| Advanced Clinical Research ( Site 0038) | Meridian | Idaho | 83642 | — |
| Heartland Research Associates, LLC ( Site 0029) | Augusta | Kansas | 67010 | — |
| Heartland Research Associates, LLC ( Site 0015) | Newton | Kansas | 67114 | — |
| Cotton O'Neil Research Center ( Site 0014) | Topeka | Kansas | 66604 | — |
| Kentucky Pediatric/Adult Research Inc ( Site 0012) | Bardstown | Kentucky | 40004 | — |
| University of Louisville: Pediatric Clinical Trials Unit ( Site 0025) | Louisville | Kentucky | 40202 | — |
| ACC Pediatric Research ( Site 0041) | Haughton | Louisiana | 71037 | — |
| The Center For Pharmaceutical Research PC ( Site 0011) | Kansas City | Missouri | 64114 | — |
| Child Health Care Associates ( Site 0045) | East Syracuse | New York | 13057 | — |
| Blue Ridge Pediatric & Adolescent Medicine ( Site 0001) | Boone | North Carolina | 28607 | — |
| Ford, Simpson, Lively & Rice Pediatrics, PLLC ( Site 0037) | Winston-Salem | North Carolina | 27103 | — |
| Senders Pediatrics ( Site 0034) | Cleveland | Ohio | 44121 | — |
| Ohio Pediatric Research Association ( Site 0035) | Dayton | Ohio | 45414 | — |
| Kid's Way Pediatrics ( Site 0047) | Hermitage | Pennsylvania | 16148 | — |
| Palmetto Pediatrics, PA ( Site 0023) | Charleston | South Carolina | 29406 | — |
| Coastal Pediatric Research ( Site 0006) | Charleston | South Carolina | 29414 | — |
| Holston Medical Group Pediatrics ( Site 0024) | Kingsport | Tennessee | 37660 | — |
| Benchmark Research ( Site 0005) | Austin | Texas | 78705 | — |
| University of Texas Medical Branch at Galveston ( Site 0032) | Galveston | Texas | 77555 | — |
| West Houston Clinical Research Services ( Site 0009) | Houston | Texas | 77055 | — |
| Pediatric Healthcare of Northwest Houston ( Site 0027) | Tomball | Texas | 77375 | — |
| Tanner Clinic ( Site 0010) | Layton | Utah | 84041 | — |
| Wee Care Pediatrics-Roy ( Site 0043) | Roy | Utah | 84067 | — |
| J Lewis Research Inc / Foothill Family Clinic ( Site 0016) | Salt Lake City | Utah | 84109 | — |
| J Lewis Research Inc/Foothill Family Clinic South ( Site 0004) | Salt Lake City | Utah | 84121 | — |
| J Lewis Research Inc/Jordan River Family Medicine ( Site 0019) | South Jordan | Utah | 84095 | — |
| Wee Care Pediatrics ( Site 0036) | Syracuse | Utah | 84075 | — |
| Advanced Clinical Research ( Site 0020) | West Jordan | Utah | 84088 | — |
| Pediatric Research of Charlottesville, LLC ( Site 0039) | Charlottesville | Virginia | 22902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03239873, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03239873 live on ClinicalTrials.gov.