TY - JOUR
T1 - Three randomized trials of maternal influenza immunization in Mali, Nepal, and South Africa
T2 - Methods and expectations
AU - BMGF Supported Maternal Influenza Immunization Trials Investigators Group
AU - Omer, Saad B.
AU - Richards, Jennifer L.
AU - Madhi, Shabir A.
AU - Tapia, Milagritos D.
AU - Steinhoff, Mark C.
AU - Aqil, Anushka R.
AU - Wairagkar, Niteen
AU - Blackwelder, William
AU - Bresee, Joseph
AU - Coulibaly, Flanon
AU - Diallo, Boubacar
AU - Diallo, Fatoumata
AU - Chen, Wilbur
AU - Doumbia, Moussa
AU - Haidara, Fadima Cheick
AU - Keita, Adama Mamby
AU - Klimov, Alexander
AU - Kodio, Mamoudou
AU - Kotloff, Karen
AU - Levine, Myron M.
AU - Onwuchekwa, Uma
AU - Panchalingam, Sandra
AU - Pasetti, Marcela
AU - Sanogo, Doh
AU - Sow, Samba
AU - Tapia, Milagritos
AU - Tamboura, Boubou
AU - Teguete, Ibrahim
AU - Tennant, Sharon
AU - Traore, Awa
AU - Treanor, John
AU - Englund, Janet A.
AU - Katz, Joanne
AU - Khatry, Subarna K.
AU - Kuypers, Jane
AU - Labrique, Alain B.
AU - LeClerq, Steven C.
AU - Mullany, Luke C.
AU - Shrestha, Laxman
AU - Tielsch, James M.
AU - Adrian, Peter V.
AU - Cutland, Clare L.
AU - Hugo, Andrea
AU - Jones, Stephanie
AU - Kuwanda, Locadiah
AU - Klugman, Keith P.
AU - Neuzil, Kathleen M.
AU - van Niekerk, Nadia
AU - Nunes, Marta C.
AU - Ortiz, Justin R.
N1 - Publisher Copyright:
© 2015 The Authors.
PY - 2015/7/31
Y1 - 2015/7/31
N2 - Influenza infection in pregnancy can have adverse impacts on maternal, fetal, and infant outcomes. Influenza vaccination in pregnancy is an appealing strategy to protect pregnant women and their infants. The Bill & Melinda Gates Foundation is supporting three large, randomized trials in Nepal, Mali, and South Africa evaluating the efficacy and safety of maternal immunization to prevent influenza disease in pregnant women and their infants <6 months of age. Results from these individual studies are expected in 2014 and 2015. While the results from the three maternal immunization trials are likely to strengthen the evidence base regarding the impact of influenza immunization in pregnancy, expectations for these results should be realistic. For example, evidence from previous influenza vaccine studies - conducted in general, non-pregnant populations - suggests substantial geographic and year-to-year variability in influenza incidence and vaccine efficacy/effectiveness. Since the evidence generated from the three maternal influenza immunization trials will be complementary, in this paper we present a side-by-side description of the three studies as well as the similarities and differences between these trials in terms of study location, design, outcome evaluation, and laboratory and epidemiological methods. We also describe the likely remaining knowledge gap after the results from these trials become available along with a description of the analyses that will be conducted when the results from these individual data are pooled. Moreover, we highlight that additional research on logistics of seasonal influenza vaccine supply, surveillance and strain matching, and optimal delivery strategies for pregnant women will be important for informing global policy related to maternal influenza immunization.
AB - Influenza infection in pregnancy can have adverse impacts on maternal, fetal, and infant outcomes. Influenza vaccination in pregnancy is an appealing strategy to protect pregnant women and their infants. The Bill & Melinda Gates Foundation is supporting three large, randomized trials in Nepal, Mali, and South Africa evaluating the efficacy and safety of maternal immunization to prevent influenza disease in pregnant women and their infants <6 months of age. Results from these individual studies are expected in 2014 and 2015. While the results from the three maternal immunization trials are likely to strengthen the evidence base regarding the impact of influenza immunization in pregnancy, expectations for these results should be realistic. For example, evidence from previous influenza vaccine studies - conducted in general, non-pregnant populations - suggests substantial geographic and year-to-year variability in influenza incidence and vaccine efficacy/effectiveness. Since the evidence generated from the three maternal influenza immunization trials will be complementary, in this paper we present a side-by-side description of the three studies as well as the similarities and differences between these trials in terms of study location, design, outcome evaluation, and laboratory and epidemiological methods. We also describe the likely remaining knowledge gap after the results from these trials become available along with a description of the analyses that will be conducted when the results from these individual data are pooled. Moreover, we highlight that additional research on logistics of seasonal influenza vaccine supply, surveillance and strain matching, and optimal delivery strategies for pregnant women will be important for informing global policy related to maternal influenza immunization.
KW - Influenza
KW - Mali
KW - Maternal immunization
KW - Nepal
KW - Pooled analyses
KW - South Africa
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U2 - 10.1016/j.vaccine.2015.05.077
DO - 10.1016/j.vaccine.2015.05.077
M3 - Review article
C2 - 26095508
AN - SCOPUS:84937514112
SN - 0264-410X
VL - 33
SP - 3801
EP - 3812
JO - Vaccine
JF - Vaccine
IS - 32
ER -