One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11140%2F18%3A10361555" target="_blank" >RIV/00216208:11140/18:10361555 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1016/j.vaccine.2017.11.081" target="_blank" >http://dx.doi.org/10.1016/j.vaccine.2017.11.081</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.vaccine.2017.11.081" target="_blank" >10.1016/j.vaccine.2017.11.081</a>

Result language

angličtina

Original language name

One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life

Original language description

Background: This phase III B follow-up of an initial multicenter study (NCT00226499) will evaluate the ten-year efficacy of two doses of the combined measles-mumps-rubella varicella vaccine (MMRV) and one dose of the live attenuated varicella vaccine (V) versus a measles-mumps-rubella control group (MMR) for the prevention of clinical varicella disease. Here we present efficacy results for six years post-vaccination. Methods: In phase A of the study, healthy children aged 12-22 months from ten European countries were randomized (3:3:1) and received either two doses of MMRV, or one dose of combined MMR and one dose of monovalent varicella vaccine (MMR+V), or two doses of the MMR vaccine (control), 42 days apart. Vaccine efficacy against all and against moderate or severe varicella (confirmed by detection of viral DNA or epidemiological link) was assessed from six weeks up to six years post-dose 2 for the MMRV and MMR+V groups, and was calculated with 95% confidence intervals (CI). The severity of varicella was calculated using the modified Vasquez scale (mildLESS-THAN OR EQUAL TO7; moderately severe=8-15; severeGREATER-THAN OR EQUAL TO16). Herpes zoster cases were also recorded. Results: 5289 children (MMRV=2279, mean age=14.2, standard deviation [SD]=2.5; MMR+V=2266, mean age=14.2, SD=2.4; MMR=744 mean age=14.2, SD=2.5 months) were included in the efficacy cohort. 815 varicella cases were confirmed. Efficacy of two doses of MMRV against all and against moderate or severe varicella was 95.0% (93,6-96,2) and 99.0% (97.7-99.6), respectively. Efficacy of one dose of varicella vaccine against all and against moderate or severe varicella was 67.0% (95%CI: 61.8-71.4) and 90.3% (95%CI: 86.9-92.8), respectively. There were four confirmed herpes zoster cases (MMR+V=2, MMR=2), all were mild and three tested positive for the wild-type virus.Conclusions: Two doses of the MMRV vaccine and one dose of the varicella vaccine remain efficacious through six years post-vaccination.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30304 - Public and environmental health

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2018

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Vaccine

ISSN

0264-410X

e-ISSN

—

Volume of the periodical

36

Issue of the periodical within the volume

3

Country of publishing house

GB - UNITED KINGDOM

Number of pages

7

Pages from-to

381-387

UT code for WoS article

000429509600007

EID of the result in the Scopus database

2-s2.0-85040769987