PMID- 32429738
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20210621
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 16
IP  - 11
DP  - 2020 Nov 1
TI  - A double-blind, randomized, multicenter, controlled study to evaluate the 
      immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX) passage 
      extension 34 (PE34) process administered concomitantly with measles, mumps, and 
      rubella vaccine (M-M-R II).
PG  - 2634-2640
LID - 10.1080/21645515.2020.1743122 [doi]
AB  - The varicella vaccine passage extension (VAR-PE) process was undertaken to extend 
      the availability of varicella zoster virus (VZV)-containing vaccines. This study 
      (V210-A03; NCT03239873) assessed the immunogenicity, safety, and tolerability of 
      VAR-PE process in comparison with varicella vaccine commercial product 2016 (VAR) 
      randomized 1:1 in 600 healthy children 12 to 23 months of age administered 
      concomitantly with measles-mumps-rubella (MMR) vaccine. The VZV seroconversion 
      rate at 6 weeks Postdose 1 in the PP population was 100% for both groups. VZV 
      antibody response rates and GMTs of VZV antibodies to VAR-PE induced and were 
      non-inferior to those induced by VAR 6 weeks Postdose 1. From Day 1 through Day 
      42, adverse events (AEs) were reported by 81.3% of participants Postdose 1 and 
      67.9% Postdose 2. From Day 1 through Day 42 Postdose 1, injection-site AEs 
      related to varicella vaccine were reported by 31.1% and 29.7% of participants in 
      VAR-PE and VAR, respectively, and Postdose 2, by 25.7% and 25.5% of participants 
      in the VAR-PE and VAR groups, respectively. Systemic AEs were generally 
      comparable for the 2 vaccination groups, with the exception of pyrexia and otitis 
      media higher in VAR-PE, and diarrhea and teething higher in VAR. The incidence of 
      systemic AEs was generally lower Postdose 2 compared with Postdose 1.
FAU - Silas, Peter E
AU  - Silas PE
AD  - Wee Care Pediatrics , Syracuse, UT, USA.
FAU - Zissman, Edward N
AU  - Zissman EN
AD  - Children's Research at Altamonte Pediatric Associates , Lake Mary, FL, USA.
FAU - Gardner, Julie
AU  - Gardner J
AD  - Merck & Co., Inc ., Kenilworth, NJ, USA.
FAU - Helian, Shanjun
AU  - Helian S
AUID- ORCID: 0000-0002-7008-580X
AD  - Merck & Co., Inc ., Kenilworth, NJ, USA.
FAU - Lee, Andrew W
AU  - Lee AW
AD  - Merck & Co., Inc ., Kenilworth, NJ, USA.
FAU - Platt, Heather L
AU  - Platt HL
AUID- ORCID: 0000-0002-0910-6077
AD  - Merck & Co., Inc ., Kenilworth, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03239873
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200519
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Chickenpox Vaccine)
RN  - 0 (Measles-Mumps-Rubella Vaccine)
RN  - 0 (Rubella Vaccine)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Viral Vaccines)
SB  - IM
MH  - Antibodies, Viral
MH  - Chickenpox Vaccine/adverse effects
MH  - Child
MH  - Humans
MH  - Infant
MH  - *Measles
MH  - Measles-Mumps-Rubella Vaccine/adverse effects
MH  - *Mumps/prevention & control
MH  - *Rubella
MH  - Rubella Vaccine
MH  - Vaccines, Combined/adverse effects
MH  - *Viral Vaccines
PMC - PMC7733937
OTO - NOTNLM
OT  - Varicella
OT  - immunogenicity
OT  - measles
OT  - mumps
OT  - rubella
OT  - safety
EDAT- 2020/05/21 06:00
MHDA- 2021/06/22 06:00
PMCR- 2021/05/19
CRDT- 2020/05/21 06:00
PHST- 2020/05/21 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/05/21 06:00 [entrez]
PHST- 2021/05/19 00:00 [pmc-release]
AID - 1743122 [pii]
AID - 10.1080/21645515.2020.1743122 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2020 Nov 1;16(11):2634-2640. doi: 
      10.1080/21645515.2020.1743122. Epub 2020 May 19.