PMID- 20600487
OWN - NLM
STAT- MEDLINE
DCOM- 20101115
LR  - 20220317
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 28
IP  - 36
DP  - 2010 Aug 16
TI  - Safety profile of live varicella virus vaccine (Oka/Merck): five-year results of 
      the European Varicella Zoster Virus Identification Program (EU VZVIP).
PG  - 5878-82
LID - 10.1016/j.vaccine.2010.06.056 [doi]
AB  - BACKGROUND: VARIVAX (Oka/Merck) is a live varicella vaccine, licensed in Europe 
      since 2003. In addition to routine safety surveillance, the Varicella Zoster 
      Virus Identification Program (VZVIP) analyzes clinical samples to establish 
      whether adverse events (AEs) are associated with wild-type (wt) or vaccine 
      varicella zoster virus (vVZV) strain. The European VZVIP provides data on VZV 
      clade distribution. METHODS: Samples were collected from patients with selected 
      AEs; the VZV strain was determined using polymerase chain reaction. RESULTS: From 
      October 2003 to September 2008, 1006 spontaneous AE reports were analyzed (88% 
      non-serious). Samples from 76/585 cases with selected AEs were collected. Of 55 
      VZV-positive/typable samples, wtVZV was detected in 40 and vVZV in 15 samples. 
      Most rashes (32/44) <or=42 days postvaccination were associated with wtVZV. For 
      breakthrough varicella, 6/9 cases were wtVZV-positive; none were vVZV-positive. 
      For herpes zoster 9/17 cases were VZV-positive: eight vVZV, one wtVZV. One case 
      of mild encephalitis was associated with vVZV. One of three cases of suspected 
      secondary vVZV transmission was confirmed. Most wtVZV was clade 3 and clade 1. 
      CONCLUSIONS: European experience confirms that Oka/Merck vaccine is generally 
      well tolerated. wtVZV genotypes were consistent with the molecular epidemiology 
      of VZV in Europe.
FAU - Goulleret, Nicolas
AU  - Goulleret N
AD  - Sanofi Pasteur MSD, Lyon, France. NGoulleret@spmsd.com
FAU - Mauvisseau, Elodie
AU  - Mauvisseau E
FAU - Essevaz-Roulet, Melanie
AU  - Essevaz-Roulet M
FAU - Quinlivan, Mark
AU  - Quinlivan M
FAU - Breuer, Judy
AU  - Breuer J
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100630
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Chickenpox Vaccine)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Chickenpox/epidemiology/prevention & control
MH  - Chickenpox Vaccine/administration & dosage/*adverse effects/immunology
MH  - Child
MH  - Child, Preschool
MH  - Europe/epidemiology
MH  - Genotype
MH  - Herpes Zoster/epidemiology/prevention & control
MH  - Herpesvirus 3, Human/*genetics
MH  - Humans
MH  - Infant
MH  - Molecular Epidemiology
MH  - *Product Surveillance, Postmarketing
EDAT- 2010/07/06 06:00
MHDA- 2010/11/16 06:00
CRDT- 2010/07/06 06:00
PHST- 2010/03/02 00:00 [received]
PHST- 2010/06/15 00:00 [revised]
PHST- 2010/06/16 00:00 [accepted]
PHST- 2010/07/06 06:00 [entrez]
PHST- 2010/07/06 06:00 [pubmed]
PHST- 2010/11/16 06:00 [medline]
AID - S0264-410X(10)00867-4 [pii]
AID - 10.1016/j.vaccine.2010.06.056 [doi]
PST - ppublish
SO  - Vaccine. 2010 Aug 16;28(36):5878-82. doi: 10.1016/j.vaccine.2010.06.056. Epub 
      2010 Jun 30.