drugset / Trial / NCT01034254
Field Trial of Maternal Influenza Immunization in Asia
Phase 3
Completed
3693 enrolled
Children's Hospital Medical Center, Cincinnati
Bill and Melinda Gates Foundation · collabJohns Hopkins Bloomberg School of Public Health · collabSeattle Children's Hospital · collabThrasher Research Fund · collabTribhuvan University, Nepal · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number of large scale randomized trials have been conducted over the past 20 years.
Timeline
- Start
- 2010-11
- Primary completion
- 2014-05
- Completion
- 2017-10
Outcome
Met primary endpoint
paper Immunisation reduced maternal febrile influenza-like illness with an overall efficacy of 19% (95% CI 1 to 34) in the combined cohorts; PMID 28522338 ↗
paper For laboratory-confirmed influenza infections in infants aged 0-6 months, immunisation had an overall efficacy for the combined cohorts of 30% (95% CI 5 to 48); PMID 28522338 ↗
paper Maternal immunisation reduced the rates of low birthweight by 15% (95% CI 3-25) in both cohorts combined. PMID 28522338 ↗
Publications
- Background Cox S, Posner SF, McPheeters M, Jamieson DJ, Kourtis AP, Meikle S. Hospitalizations with respiratory illness among pregnant women during influenza season. Obstet Gynecol. 2006 Jun;107(6):1315-22. doi: 10.1097/01.AOG.0000218702.92005.bb.
- Background Dodds L, McNeil SA, Fell DB, Allen VM, Coombs A, Scott J, MacDonald N. Impact of influenza exposure on rates of hospital admissions and physician visits because of respiratory illness among pregnant women. CMAJ. 2007 Feb 13;176(4):463-8. doi: 10.1503/cmaj.061435.
- Background Englund JA. Maternal immunization with inactivated influenza vaccine: rationale and experience. Vaccine. 2003 Jul 28;21(24):3460-4. doi: 10.1016/s0264-410x(03)00351-7.
- Background Greenwood B. Maternal immunisation in developing countries. Vaccine. 2003 Jul 28;21(24):3436-41. doi: 10.1016/s0264-410x(03)00346-3.
- Background Healy CM, Baker CJ. Maternal immunization. Pediatr Infect Dis J. 2007 Oct;26(10):945-8. doi: 10.1097/INF.0b013e318156c18c. No abstract available.
- Background Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
- Background Mak TK, Mangtani P, Leese J, Watson JM, Pfeifer D. Influenza vaccination in pregnancy: current evidence and selected national policies. Lancet Infect Dis. 2008 Jan;8(1):44-52. doi: 10.1016/S1473-3099(07)70311-0.
- Background Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E, Omer SB, Shahid NS, Breiman RF, Steinhoff MC. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008 Oct 9;359(15):1555-64. doi: 10.1056/NEJMoa0708630. Epub 2008 Sep 17.
- Background MacDonald NE, Riley LE, Steinhoff MC. Influenza immunization in pregnancy. Obstet Gynecol. 2009 Aug;114(2 Pt 1):365-368. doi: 10.1097/AOG.0b013e3181af6ce8.
- Background Tamma PD, Ault KA, del Rio C, Steinhoff MC, Halsey NA, Omer SB. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol. 2009 Dec;201(6):547-52. doi: 10.1016/j.ajog.2009.09.034. Epub 2009 Oct 21.
- Background Pickering LK, Baker CJ, Freed GL, Gall SA, Grogg SE, Poland GA, Rodewald LE, Schaffner W, Stinchfield P, Tan L, Zimmerman RK, Orenstein WA; Infectious Diseases Society of America. Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Sep 15;49(6):817-40. doi: 10.1086/605430.
- Background Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NS; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008. MMWR Recomm Rep. 2008 Aug 8;57(RR-7):1-60.
- Regodon Wallin A, Tielsch JM, Khatry SK, Mullany LC, Englund JA, Chu H, LeClerq SC, Katz J. Nausea, vomiting and poor appetite during pregnancy and adverse birth outcomes in rural Nepal: an observational cohort study. BMC Pregnancy Childbirth. 2020 Sep 17;20(1):545. doi: 10.1186/s12884-020-03141-1.
- Omer SB, Clark DR, Madhi SA, Tapia MD, Nunes MC, Cutland CL, Simoes EAF, Aqil AR, Katz J, Tielsch JM, Steinhoff MC, Wairagkar N; BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Efficacy, duration of protection, birth outcomes, and infant growth associated with influenza vaccination in pregnancy: a pooled analysis of three randomised controlled trials. Lancet Respir Med. 2020 Jun;8(6):597-608. doi: 10.1016/S2213-2600(19)30479-5.
- Clark DR, Omer SB, Tapia MD, Nunes MC, Cutland CL, Tielsch JM, Wairagkar N, Madhi SA; for BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Influenza or Meningococcal Immunization During Pregnancy and Mortality in Women and Infants: A Pooled Analysis of Randomized Controlled Trials. Pediatr Infect Dis J. 2020 Jul;39(7):641-644. doi: 10.1097/INF.0000000000002629.
- Murray AF, Englund JA, Kuypers J, Tielsch JM, Katz J, Khatry SK, Leclerq SC, Chu HY. Infant Pneumococcal Carriage During Influenza, RSV, and hMPV Respiratory Illness Within a Maternal Influenza Immunization Trial. J Infect Dis. 2019 Aug 9;220(6):956-960. doi: 10.1093/infdis/jiz212.
- Katz J, Englund JA, Steinhoff MC, Khatry SK, Shrestha L, Kuypers J, Mullany LC, Chu HY, LeClerq SC, Kozuki N, Tielsch JM. Impact of Timing of Influenza Vaccination in Pregnancy on Transplacental Antibody Transfer, Influenza Incidence, and Birth Outcomes: A Randomized Trial in Rural Nepal. Clin Infect Dis. 2018 Jul 18;67(3):334-340. doi: 10.1093/cid/ciy090.
- Omer SB, Clark DR, Aqil AR, Tapia MD, Nunes MC, Kozuki N, Steinhoff MC, Madhi SA, Wairagkar N; 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 May;37(5):436-440. doi: 10.1097/INF.0000000000001914.
- Katz J, Englund JA, Steinhoff MC, Khatry SK, Shrestha L, Kuypers J, Mullany LC, Chu HY, LeClerq SC, Kozuki N, Tielsch JM. Nutritional status of infants at six months of age following maternal influenza immunization: A randomized placebo-controlled trial in rural Nepal. Vaccine. 2017 Dec 4;35(48 Pt B):6743-6750. doi: 10.1016/j.vaccine.2017.09.095. Epub 2017 Oct 31.
- Kozuki N, Katz J, Englund JA, Steinhoff MC, Khatry SK, Shrestha L, Kuypers J, Mullany LC, Chu HY, LeClerq SC, Tielsch JM. Impact of maternal vaccination timing and influenza virus circulation on birth outcomes in rural Nepal. Int J Gynaecol Obstet. 2018 Jan;140(1):65-72. doi: 10.1002/ijgo.12341. Epub 2017 Nov 9.
- Steinhoff MC, Katz J, Englund JA, Khatry SK, Shrestha L, Kuypers J, Stewart L, Mullany LC, Chu HY, LeClerq SC, Kozuki N, McNeal M, Reedy AM, Tielsch JM. Year-round influenza immunisation during pregnancy in Nepal: a phase 4, randomised, placebo-controlled trial. Lancet Infect Dis. 2017 Sep;17(9):981-989. doi: 10.1016/S1473-3099(17)30252-9. Epub 2017 May 15.
- Tielsch JM, Steinhoff M, Katz J, Englund JA, Kuypers J, Khatry SK, Shrestha L, LeClerq SC. Designs of two randomized, community-based trials to assess the impact of influenza immunization during pregnancy on respiratory illness among pregnant women and their infants and reproductive outcomes in rural Nepal. BMC Pregnancy Childbirth. 2015 Feb 20;15:40. doi: 10.1186/s12884-015-0470-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza vaccine | Vaccine | — | — |