Sheila Isanaka|Céline Langendorf|Monica McNeal|Nicole Meyer|Brian D. Plikaytis|Souna Garba|Nathan Sayinzoga-Makombe|Souna Garba|Ousmane Guindo|Rockyiath Makarimi|Marie Francoise Scherrer|Eric Adéhossi|Iza Ciglene?ki|Rebecca F. Grais
Rotavirus vaccine efficacy up to 2 years of age and against diverse circulating rotavirus strains in Niger: Extended follow-up of a randomized controlled trial
Harvard Global Health Institute|Harvard University|Cincinnati Children's Hospital Medical Center|University of Cincinnati|Cincinnati Children's Hospital Medical Center|University of Cincinnati|Biostatistical Consulting (United States)|United Nations Children's Fund Niger|United Nations Children's Fund Niger|United Nations Children's Fund Niger|United Nations Children's Fund Niger|United Nations Children's Fund Niger|National Hospital Niamey|Médecins Sans Frontières
background rotavirus vaccination recommended countries reduce burden diarrhearelated morbidity mortality children resourcelimited settings rotavirus vaccination national immunization program important cost implications evidence protection beyond first year life evolving variety rotavirus strains important assessed extended strainspecific vaccine efficacy heatstable affordable oral rotavirus vaccine rotasiil serum institute india pune india severe rotavirus gastroenteritis srvge among healthy infants niger methods findings august 2014 november 2015 infants randomized 11 ratio receive 3 doses rotasiil placebo approximately 6 10 14 weeks age episodes gastroenteritis assessed active passive surveillance graded using vesikari score primary endpoint vaccine efficacy 3 doses vaccine versus placebo first episode laboratoryconfirmed srvge vesikari score 11 28 days dose 3 previously reported time primary analysis median age 98 months present paper analyses extended efficacy undertaken 3 periods 28 days dose 3 1 year age 1 2 years age combined period 28 days dose 3 2 years age individual rotavirus g type among 3508 infants included perprotocol efficacy analysis mean age first dose 65 weeks 49 male vaccine provided significant protection srvge first year life 396 998 cases per 100 personyears vaccine placebo respectively vaccine efficacy 603 95 ci 436 721 entire efficacy followup period 2 years age 213 469 cases per 100 personyears vaccine placebo respectively vaccine efficacy 547 95 ci 381 668 difference statistically significant second year life 2 years age rotavirus vaccination prevented 256 episodes srvge per 100 childyears estimates efficacy srvge individual rotavirus genotype consistent overall protective efficacy study limitations include limited generalizability settings administration oral polio virus due low concomitant administration limited power assess vaccine efficacy second year life owing low number events among older children potential bias due censoring placebo children time study vaccine receipt suboptimal adapted severity scoring based vesikari score designed use settings high parental literacy conclusions rotasiil provided protection srvge infants extended followup period approximately 2 years protection significant first year life disease burden risk death highest changing pattern rotavirus strains 2year efficacy period rotavirus vaccines safe effective protective multiple strains represent best hope preventing severe consequences rotavirus infection especially resourcelimited settings access care may limited studies provide valuable information planning national immunization programs future vaccine development trial registration clinicaltrialsgov nct02145000