Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023698%3A_____%2F20%3AN0000014" target="_blank" >RIV/00023698:_____/20:N0000014 - isvavai.cz</a>
Alternative codes found
RIV/00179906:_____/20:10408677
Result on the web
<a href="https://doi.org/10.1016/j.vaccine.2019.10.105" target="_blank" >https://doi.org/10.1016/j.vaccine.2019.10.105</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.vaccine.2019.10.105" target="_blank" >10.1016/j.vaccine.2019.10.105</a>
Alternative languages
Result language
angličtina
Original language name
Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial
Original language description
Pertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach. Methods: This phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27-36 weeks' gestation with crossover <= 72-hourpostpartum immunization. Immune responses were assessed before the pregnancy dose and 1 month after, and from the umbilical cord at delivery. Superiority (primary objective) was reached if the lower limits of the 95% confidence intervals (Cis) of the pertussis geometric mean concentration (GMC) ratios (Tdap/control) in cord blood were >= 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-I neonate-related AEs of interest were recorded. Results: 687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5-19.2) for anti-filamentous hemagglutinin, 20.7 (15.9-26.9) for anti-pertactin and 8.5 (7.0-10.2) for anti-pertussis toxoid. Rates of pregnancy-/neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination. Conclusions: Tdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis disease.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30214 - Obstetrics and gynaecology
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2020
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Vaccine
ISSN
0264-410X
e-ISSN
1873-2518
Volume of the periodical
38
Issue of the periodical within the volume
8
Country of publishing house
GB - UNITED KINGDOM
Number of pages
10
Pages from-to
2095-2104
UT code for WoS article
000518490000028
EID of the result in the Scopus database
2-s2.0-85079195025