PMID- 29087781
OWN - NLM
STAT- MEDLINE
DCOM- 20190104
LR  - 20190104
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 14
IP  - 2
DP  - 2018 Feb 1
TI  - Evaluation of immunogenicity and safety of VARIVAX New Seed Process (NSP) in 
      children.
PG  - 442-449
LID - 10.1080/21645515.2017.1388479 [doi]
AB  - Prior to availability of an effective vaccine, an estimated 4 million cases of 
      varicella occurred annually in the United States, resulting in 10,000 
      hospitalizations and over 100 deaths. With the increased usage of a two-dose 
      varicella vaccine (as recommended by the ACIP), approval of other VZV-containing 
      products and the adoption of varicella vaccination in additional countries, the 
      demand for VZV-containing vaccines has increased. This study (NCT02062502) 
      evaluated the safety, tolerability, and immunogenicity of VARIVAX (VAR, 
      varicella vaccine live) manufactured using a new seed manufacturing process 
      (VAR(NSP)) compared to the currently licensed VAR. Healthy children 12-23 months 
      were randomized (1:1) into Group 1 (2 doses of VAR(NSP) given concomitantly with 
      M-M-R II,  approximately 3 months apart) versus  Group 2 (2 doses of VAR given concomitantly 
      with M-M-R II,  approximately 3 months apart).  Serum samples collected prior to vaccination 
      on Day 1 and 6 weeks Postdose 1 were tested for antibody to VZV using a 
      glycoprotein enzyme-linked immunosorbent assay (gpELISA).  Safety was assessed 
      Days 1 to 42 following each vaccination. Six weeks Postdose 1, the response rate 
      (percent of subjects with VZV antibody titer >/=5 gpELISA units/mL) of VAR(NSP) was 
      non-inferior compared to VAR.  Vaccine-related adverse events (AEs) were 
      comparable with the exception of measles-like rash, where a greater number of 
      rashes were observed with VAR than VAR(NSP).  The 2 vaccination groups were 
      comparable with incidence rates of AEs, injection-site AEs, vaccine-related AEs, 
      systemic AEs, and serious AEs. This new process is an important innovation for 
      the extreme demand of sustaining sufficient supplies of varicella vaccine to 
      protect our communities against diseases caused by VZV.
FAU - Senders, Shelly D
AU  - Senders SD
AD  - a Senders Pediatrics , Cleveland , OH , USA.
FAU - Bundick, Nickoya D
AU  - Bundick ND
AD  - b Merck Research Laboratories, Merck & Co., Inc. , Kenilworth , NJ , USA.
FAU - Li, Jianing
AU  - Li J
AD  - b Merck Research Laboratories, Merck & Co., Inc. , Kenilworth , NJ , USA.
FAU - Zecca, Carol
AU  - Zecca C
AD  - b Merck Research Laboratories, Merck & Co., Inc. , Kenilworth , NJ , USA.
FAU - Helmond, Frans A
AU  - Helmond FA
AD  - b Merck Research Laboratories, Merck & Co., Inc. , Kenilworth , NJ , USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171211
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)
SB  - IM
MH  - Antibodies, Viral/blood
MH  - Chickenpox/*prevention & control
MH  - Chickenpox Vaccine/administration & dosage/*adverse effects/immunology
MH  - Female
MH  - Humans
MH  - Immunization Schedule
MH  - Infant
MH  - Male
MH  - Measles-Mumps-Rubella Vaccine/administration & dosage
MH  - Vaccination/methods
PMC - PMC5806650
OTO - NOTNLM
OT  - immunogenicity
OT  - safety
OT  - vaccine
OT  - varicella
EDAT- 2017/11/01 06:00
MHDA- 2019/01/05 06:00
PMCR- 2018/12/11
CRDT- 2017/11/01 06:00
PHST- 2017/11/01 06:00 [pubmed]
PHST- 2019/01/05 06:00 [medline]
PHST- 2017/11/01 06:00 [entrez]
PHST- 2018/12/11 00:00 [pmc-release]
AID - 1388479 [pii]
AID - 10.1080/21645515.2017.1388479 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 
      10.1080/21645515.2017.1388479. Epub 2017 Dec 11.