Influenza or Meningococcal Immunization During Pregnancy and Mortality in Women and Infants: A Pooled Analysis of Randomized Controlled Trials
Dayna R Clark, Saad B Omer, Milagritos D Tapia, Marta C Nunes, Clare L Cutland, James M Tielsch, Niteen Wairagkar, Shabir A Madhi, for BMGF Supported Maternal Influenza Immunization Trials Investigators Group, Dayna R Clark, Saad B Omer, Milagritos D Tapia, Marta C Nunes, Clare L Cutland, James M Tielsch, Niteen Wairagkar, Shabir A Madhi, for BMGF Supported Maternal Influenza Immunization Trials Investigators Group
Abstract
This analysis includes pooled data from 2 placebo-controlled maternal influenza immunization trials, with a separate analysis on a meningococcal conjugate vaccine-controlled maternal influenza immunization trial. Maternal influenza immunization was not associated with infant or maternal all-cause mortality in placebo-controlled trials. In the meningococcal conjugate vaccine-controlled trial, there were fewer deaths during low or any influenza circulation weeks among infants whose mothers received meningococcal conjugate vaccine. ClinicalTrials.gov identifiers: NCT01430689, NCT01034254 and NCT02465190.
Conflict of interest statement
Dr. Omer and Ms. Clark serve as consultants to the Bill & Melinda Gates Foundation and received compensation for these services. Original trials were funded by the Bill & Melinda Gates Foundation. We declare no additional competing interests.
Figures
References
- Rasmussen SA, Jamieson DJ, Uyeki TM. Effects of influenza on pregnant women and infants. Am J Obstet Gynecol. 2012;207(3 suppl):S3–S8.
- Mertz D, Geraci J, Winkup J, et al. Pregnancy as a risk factor for severe outcomes from influenza virus infection: a systematic review and meta-analysis of observational studies. Vaccine. 2017;35:521–528.
- Steinhoff MC, Omer SB, Roy E, et al. Influenza immunization in pregnancy–antibody responses in mothers and infants. N Engl J Med. 2010;362:1644–1646.
- Zaman K, Roy E, Arifeen SE, et al. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008;359:1555–1564.
- Steinhoff MC, Katz J, Englund JA, et al. Year-round influenza immunisation during pregnancy in Nepal: a phase 4, randomised, placebo-controlled trial. Lancet Infect Dis. 2017;17:981–989.
- Tapia MD, Sow SO, Tamboura B, et al. Maternal immunisation with trivalent inactivated influenza vaccine for prevention of influenza in infants in Mali: a prospective, active-controlled, observer-blind, randomised phase 4 trial. Lancet Infect Dis. 2016;16:1026–1035.
- Madhi SA, Nunes MC, Cutland CL. Influenza vaccination of pregnant women and protection of their infants. N Engl J Med. 2014;371:2340.
- Gabutti G, Stefanati A, Kuhdari P. Epidemiology of neisseria meningitidis infections: case distribution by age and relevance of carriage. J Prev Med Hyg. 2015;56:E116–E120.
- Shaker R, Fayad D, Dbaibo G. Challenges and opportunities for meningococcal vaccination in the developing world. Hum Vaccin Immunother. 2018;14:1084–1097.
- Omer SB, Richards JL, Madhi SA, et al. ; BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Three randomized trials of maternal influenza immunization in Mali, Nepal, and South Africa: methods and expectations. Vaccine. 2015;33:3801–3812.
- Omer SB, Clark DR, Aqil AR, et al. ; for BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Maternal influenza immunization and prevention of severe clinical pneumonia in young infants: analysis of randomized controlled trials conducted in Nepal, Mali and South Africa. Pediatr Infect Dis J. 2018;37:436–440.
- Deaths averted by influenza vaccination in the U.S. during the seasons 2005/06 through 2013/14. Available at: . Accessed August 31, 2019.
- Sukumaran L, McCarthy NL, Kharbanda EO, et al. Infant hospitalizations and mortality after maternal vaccination. Pediatrics. 2018;141:e20173310.
- Walsh LK, Donelle J, Dodds L, et al. Health outcomes of young children born to mothers who received 2009 pandemic H1N1 influenza vaccination during pregnancy: retrospective cohort study. BMJ. 2019;366:l4151.
- Mertz D, Lo CK, Lytvyn L, et al. ; FLURISK-INVESTIGATORS. Pregnancy as a risk factor for severe influenza infection: an individual participant data meta-analysis. BMC Infect Dis. 2019;19:683.
- Tapia MD, Tennant SM, Bornstein K, et al. Invasive nontyphoidal salmonella infections among children in Mali, 2002-2014: microbiological and epidemiologic features guide vaccine development. Clin Infect Dis. 2015;61:(suppl 4):S332–S338.
- A 20-year ecological study of the temporal association between influenza and meningococcal disease. - PubMed - NCBI. Available at: . Accessed August 31, 2019.
- Findlow H, Tapia MD, Sow SO, et al. Kinetics of maternally-derived serogroup A, C, Y and W-specific meningococcal immunoglobulin G in Malian women and infants. Vaccine. 2019;37:2477–2481.
Source: PubMed