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[Is it ethically acceptable to invite a pregnant woman to enroll in a clinical trial with Tdap if it could entail not being vaccinated with Tdap before delivery?]

Abstract：

:Pertussis incidence has increased in recent years, especially among infants aged <2months. A number of Spanish regions have started a vaccination program with Tdap vaccine to all pregnant women in the third trimester of pregnancy. An observational study has shown that this strategy reduces the number of cases of pertussis by 90% in infants aged <2months. Mathematical models showed that a cocooning strategy (i.e. vaccination of the mother at immediate postpartum, and other adults and adolescents who have close contact with the newborn and caregivers) will reduce the incidence of pertussis by 70% in infants aged <2months. It is intended to conduct a clinical trial in which 340 pregnant women will receive Tdap vaccine, whereas another 340 pregnant woman will be vaccinated soon after delivery. Vaccination with Tdap will be offered to all partners and caregivers of the newborn. After assessing both the ethical and scientific reasons supporting the trial, it is concluded that it is ethically and legally acceptable to invite pregnant women living in communities where Tdap vaccination has been implemented to participate in the trial.

journal_name

Enferm Infecc Microbiol Clin

journal_title

Enfermedades infecciosas y microbiologia clinica

authors

Dal-Ré R

doi

10.1016/j.eimc.2015.06.002

subject

Has Abstract

pub_date

2017-02-01 00:00:00

pages

116-121

issue

2

eissn

0213-005X

issn

1578-1852

pii

S0213-005X(15)00248-7

journal_volume

35

pub_type

杂志文章,评审

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