Year-round influenza immunisation during pregnancy in Nepal: a phase 4, randomised, placebo-controlled trial

The Lancet Infectious Diseases
Mark C SteinhoffJames Tielsch

Abstract

Influenza immunisation during pregnancy is recommended but not widely implemented in some low-income regions. We assessed the safety and efficacy in mothers and infants of year-round maternal influenza immunisation in Nepal, where influenza viruses circulate throughout the year. In this phase 4, randomised, placebo-controlled trial, we enrolled two consecutive sequential annual cohorts of pregnant women from the Sarlahi district in southern Nepal. We randomised mothers 1:1 to receive seasonally recommended trivalent inactivated influenza vaccine or saline placebo in blocks of eight, stratified by gestational age at enrolment (17-25 weeks vs 26-34 weeks). Women were eligible if they were married, 15-40 years of age, 17-34 weeks' gestation at enrolment, and had not previously received any influenza vaccine that season. We collected serum samples before and after immunisation, and cord blood from a subset of women and infants. Staff masked to allocation made home visits every week from enrolment to 6 months after delivery. Midnasal swabs for respiratory virus PCR testing were collected during maternal acute febrile respiratory infections, and from infants with any respiratory symptom. We assessed vaccine immunogenicity, safety, an...Continue Reading

Associated Clinical Trials

References

Feb 1, 1996·Obstetrics and Gynecology·G R AlexanderM Kogan
Mar 23, 2004·American Journal of Epidemiology·Guangyong Zou
Sep 19, 2008·The New England Journal of Medicine·K ZamanMark C Steinhoff
Sep 22, 2010·The Pediatric Infectious Disease Journal·Emily HenkleK Zaman
Feb 23, 2012·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Mark C SteinhoffK Zaman
Sep 29, 2012·Emerging Infectious Diseases·Jane KuypersMichael Boeckh
Jun 12, 2013·Lancet·Joanne KatzUNKNOWN CHERG Small-for-Gestational-Age-Preterm Birth Working Group
May 20, 2014·Bulletin of the World Health Organization·Nancy Cox
May 20, 2014·Bulletin of the World Health Organization·Siddhartha SahaRenu B Lal
Jul 30, 2014·Diagnostic Microbiology and Infectious Disease·Elizabeth P SchlaudeckerMark C Steinhoff
Sep 4, 2014·The New England Journal of Medicine·Shabir A MadhiUNKNOWN Maternal Flu Trial (Matflu) Team
Sep 1, 2015·Vaccine·Philipp LambachMichael Pfleiderer
Jan 20, 2016·Influenza and Other Respiratory Viruses·Siddhartha SahaUNKNOWN Group of Asian Researchers on Influenza (GARI)
Feb 5, 2016·Influenza and Other Respiratory Viruses·Siddhivinayak HirveWenqing Zhang

❮ Previous
Next ❯

Citations

Dec 12, 2017·Human Vaccines & Immunotherapeutics·Nicola PrincipiUNKNOWN ESCMID Vaccine Study Group (EVASG)
Feb 17, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Joanne KatzJames M Tielsch
Feb 15, 2018·The Pediatric Infectious Disease Journal·Saad B OmerUNKNOWN for BMGF Supported Maternal Influenza Immunization Trials Investigators Group
Feb 28, 2018·The Pediatric Infectious Disease Journal·Kathleen M Neuzil
Apr 19, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·S M Iftekhar UddinJoanne Katz
May 2, 2018·Expert Review of Vaccines·Paul LoubetOdile Launay
Oct 7, 2017·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Naoko KozukiJames M Tielsch
Jan 13, 2018·Future Microbiology·Lucy K SomervilleJen Kok
Jul 20, 2018·Human Vaccines & Immunotherapeutics·Shabir A Madhi, Marta C Nunes
Oct 12, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Mark G ThompsonUNKNOWN PREVENT Workgroup
Nov 8, 2018·The American Journal of Tropical Medicine and Hygiene·Alastair F MurrayHelen Y Chu
Nov 2, 2018·Human Vaccines & Immunotherapeutics·Michelle L GilesAllen Cheng
Nov 14, 2018·Journal of the Pediatric Infectious Diseases Society·Jim BoonyaratanakornkitHelen Y Chu
Jan 12, 2019·Human Vaccines & Immunotherapeutics·Alberto Donzelli
Apr 23, 2019·Human Vaccines & Immunotherapeutics·Deshayne B FellKathryn M Edwards
Apr 25, 2019·Human Vaccines & Immunotherapeutics·Alberto Donzelli
Jan 29, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Aldiouma DialloJohn C Victor
Jun 23, 2019·Expert Review of Vaccines·Justin R Ortiz, Kathleen M Neuzil
Aug 8, 2019·Journal of Medical Virology·Jane KuypersJanet A Englund
Jul 21, 2017·Emerging Infectious Diseases·Jennifer L LenahanHelen Y Chu
Nov 2, 2019·The Journal of Infectious Diseases·Cheryl Cohen, Marta C Nunes
Nov 15, 2019·Human Vaccines & Immunotherapeutics·Alexandre DescampsBéatrice Blondel
Nov 27, 2019·The American Journal of Tropical Medicine and Hygiene·Kira L NewmanHelen Y Chu
Oct 17, 2019·Journal of Travel Medicine·Roni NasserAmi Neuberger
Sep 19, 2019·Human Vaccines & Immunotherapeutics·Timo VesikariViviane Gresset-Bourgeois
May 8, 2020·The Pediatric Infectious Disease Journal·Dayna R ClarkUNKNOWN for BMGF Supported Maternal Influenza Immunization Trials Investigators Group
Mar 27, 2019·Obstetrics and Gynecology·Flor M Munoz, Denise J Jamieson
Oct 28, 2019·The Journal of Maternal-fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians·Eleonora BrilloErsilia Buonomo
Mar 22, 2018·Frontiers in Immunology·Flor M Munoz
Dec 23, 2019·Maternal and Child Health Journal·Trang Ho Thu QuachJosé F Cordero
Apr 29, 2020·Journal of Perinatology : Official Journal of the California Perinatal Association·Cyril EngmannAjoke Sobanjo-Ter Meulen

❮ Previous
Next ❯

Related Concepts

Related Feeds

Birth Defects

Birth defects encompass structural and functional alterations that occur during embryonic or fetal development and are present since birth. The cause may be genetic, environmental or unknown and can result in physical and/or mental impairment. Here is the latest research on birth defects.

Allergy & Infectious Diseases

Allergies result from the hyperreactivity of the immune system to some environmental substance and can be life-threatening. Infectious diseases are caused by organisms including bacteria, viruses, fungi and parasites. They can be transmitted different ways, such as person-to-person. Here is the latest research on allergy and infectious diseases.

Allergy & Infectious Diseases (ASM)

Allergies result from the hyperreactivity of the immune system to some environmental substance and can be life-threatening. Infectious diseases are caused by organisms including bacteria, viruses, fungi and parasites. They can be transmitted different ways, such as person-to-person. Here is the latest research on allergy and infectious diseases.