PMID- 31216218
OWN - NLM
STAT- MEDLINE
DCOM- 20200514
LR  - 20200514
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 15
IP  - 12
DP  - 2019
TI  - Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine 
      when administered during pregnancy as part of the maternal immunization program 
      in Brazil: a single center, observational, retrospective, cohort study.
PG  - 2873-2881
LID - 10.1080/21645515.2019.1627161 [doi]
AB  - Reduced antigen diphtheria-tetanus-acellular pertussis (Tdap) vaccination is 
      included in the maternal immunization program in Brazil since September 2014. We 
      investigated associations between maternal Tdap vaccination and pregnancy-related 
      adverse events (AEs) (gestational diabetes, pregnancy-related hypertension, and 
      pregnancy hemorrhage) and neonatal AEs of interest (preterm birth and small for 
      gestational age). This descriptive, observational, retrospective, single-center 
      study in Brazil (NCT02757950) compared data from medical charts of 1203 pregnant 
      women who received Tdap as part of the maternal immunization program and 
      delivered between May 2015 and February 2017 (exposed cohort) and 1259 
      unvaccinated women who delivered between September 2012 and August 2014 
      (unexposed cohort). Index dates were defined as the time of vaccination (27-39 
      gestational weeks; exposed cohort) or 27 gestational weeks (unexposed cohort). 
      Cumulative incidences were calculated as the number of women with each event 
      between index and delivery dates divided by the total number of women with 
      vaccination date available in the exposed cohort (N = 1199) or the total number 
      of women in the unexposed cohort (N = 1259). Cumulative incidences per 1000 
      persons were 8.34 versus 17.47 for gestational diabetes, 9.17 versus 24.62 for 
      pregnancy-related hypertension, 3.34 versus 15.09 for pregnancy hemorrhage, 53.38 
      versus 96.11 for preterm birth, and 57.55 versus 49.25 for small for gestational 
      age in the exposed versus unexposed cohorts. No increased risk of 
      pregnancy-related AEs or neonatal AEs of interest was found following maternal 
      vaccination with Tdap. These results should be interpreted cautiously due to 
      limitations inherent to retrospective observational studies.
FAU - Sancovski, Mauro
AU  - Sancovski M
AD  - Faculdade de Medicina do ABC, Santo Andre, Brazil.
FAU - Mesaros, Narcisa
AU  - Mesaros N
AD  - GSK, Wavre, Belgium.
FAU - Feng, Yang
AU  - Feng Y
AD  - Ningyang Group Co., Limited, C/O GSK, Wavre, Belgium.
FAU - Ceregido, M Angeles
AU  - Ceregido MA
AD  - GSK, Wavre, Belgium.
FAU - Luyts, Dominique
AU  - Luyts D
AUID- ORCID: 0000-0001-8195-1526
AD  - GSK, Wavre, Belgium.
FAU - De Barros, Eliana
AU  - De Barros E
AD  - GSK, Rio de Janeiro, Brazil.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190620
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antigens, Bacterial)
RN  - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antigens, Bacterial/*administration & dosage/immunology
MH  - Brazil
MH  - Diphtheria/*prevention & control
MH  - Diphtheria-Tetanus-acellular Pertussis Vaccines/*administration & dosage
MH  - Female
MH  - Humans
MH  - *Immunization Programs
MH  - Infant, Newborn
MH  - Pregnancy
MH  - Pregnant Women
MH  - Retrospective Studies
MH  - Risk Factors
MH  - Tetanus/*prevention & control
MH  - Whooping Cough/*prevention & control
MH  - Young Adult
PMC - PMC6930109
OTO - NOTNLM
OT  - Pertussis
OT  - adverse event
OT  - maternal vaccination
OT  - neonate
OT  - pregnancy
EDAT- 2019/06/20 06:00
MHDA- 2020/05/15 06:00
PMCR- 2019/06/20
CRDT- 2019/06/20 06:00
PHST- 2019/06/20 06:00 [pubmed]
PHST- 2020/05/15 06:00 [medline]
PHST- 2019/06/20 06:00 [entrez]
PHST- 2019/06/20 00:00 [pmc-release]
AID - 1627161 [pii]
AID - 10.1080/21645515.2019.1627161 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2019;15(12):2873-2881. doi: 10.1080/21645515.2019.1627161. 
      Epub 2019 Jun 20.