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M C Steinhoff
Dr M C Steinhoff, Cincinnati Children’s Hospital, Cincinnati, OH, USA; m.steinhoff@gmail.com
STUDY DESIGN
Design:
randomised pneumococcal vaccine-controlled trial. ClinicialTrials.gov NCT00142389.
Allocation concealment:
concealed.*
Blinding:
blinded {patients, clinicians, data collectors, outcome assessors, data analysts, and safety committee}†.*
STUDY QUESTION
Setting:
Bangladesh.
Patients:
340 mothers 18–36 years of age (mean age 25 y) in the third trimester of pregnancy. Exclusion criteria were history of systemic disease, previous complicated pregnancy or preterm delivery, abortion, congenital anomaly, or hypersensitivity to study vaccines in the past 3 years.
Intervention:
inactivated influenza vaccine (n = 172) or 23-valent pneumococcal polysaccharide vaccine (n = 168). The influenza vaccine contained strains from 2004 as recommended by the World Health Organization, including A/New Caledonia/20/99 (H1N1), A/Fujian/411/2002 (H3N2), and B/Hong Kong/330/2001.
Outcomes:
included first episode of laboratory-confirmed influenza …
Footnotes
Source of funding: Bill and Melinda Gates Foundation; US Agency for International Development; Wyeth Pharmaceuticals; Thrasher Fund; Aventis Pasteur; International Centre for Diarrheal Disease Research; Johns Hopkins Bloomberg School of Public Health.