title: First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children.
abstract: An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries.
  
  
  
  From March 2009 through January 2011, we enrolled 15,460 children in two age categories--6 to 12 weeks of age and 5 to 17 months of age--for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories.
  
  
  
  In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64).
  
  
  
  The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619 .).
authors: Albert Schweitzer Hospital, Lambarene, Gabon.
authors: Selidji Todagbe
authors: ST
authors: Agnandji
authors: Bertrand
authors: B
authors: Lell
authors: Solange Solmeheim
authors: SS
authors: Soulanoudjingar
authors: José Francisco
authors: JF
authors: Fernandes
authors: Béatrice Peggy
authors: BP
authors: Abossolo
authors: Cornelia
authors: C
authors: Conzelmann
authors: Barbara Gaelle Nfono Ondo
authors: BG
authors: Methogo
authors: Yannick
authors: Y
authors: Doucka
authors: Arnaud
authors: A
authors: Flamen
authors: Benjamin
authors: B
authors: Mordmüller
authors: Saadou
authors: S
authors: Issifou
authors: Peter Gottfried
authors: PG
authors: Kremsner
authors: Jahit
authors: J
authors: Sacarlal
authors: Pedro
authors: P
authors: Aide
authors: Miguel
authors: M
authors: Lanaspa
authors: John J
authors: JJ
authors: Aponte
authors: Arlindo
authors: A
authors: Nhamuave
authors: Diana
authors: D
authors: Quelhas
authors: Quique
authors: Q
authors: Bassat
authors: Sofia
authors: S
authors: Mandjate
authors: Eusébio
authors: E
authors: Macete
authors: Pedro
authors: P
authors: Alonso
authors: Salim
authors: S
authors: Abdulla
authors: Nahya
authors: N
authors: Salim
authors: Omar
authors: O
authors: Juma
authors: Mwanajaa
authors: M
authors: Shomari
authors: Kafuruki
authors: K
authors: Shubis
authors: Francisca
authors: F
authors: Machera
authors: Ali Said
authors: AS
authors: Hamad
authors: Rose
authors: R
authors: Minja
authors: Ali
authors: A
authors: Mtoro
authors: Alma
authors: A
authors: Sykes
authors: Saumu
authors: S
authors: Ahmed
authors: Alwisa Martin
authors: AM
authors: Urassa
authors: Ali Mohammed
authors: AM
authors: Ali
authors: Grace
authors: G
authors: Mwangoka
authors: Marcel
authors: M
authors: Tanner
authors: Halidou
authors: H
authors: Tinto
authors: Umberto
authors: U
authors: D'Alessandro
authors: Hermann
authors: H
authors: Sorgho
authors: Innocent
authors: I
authors: Valea
authors: Marc Christian
authors: MC
authors: Tahita
authors: William
authors: W
authors: Kaboré
authors: Sayouba
authors: S
authors: Ouédraogo
authors: Yara
authors: Y
authors: Sandrine
authors: Robert Tinga
authors: RT
authors: Guiguemdé
authors: Jean Bosco
authors: JB
authors: Ouédraogo
authors: Mary J
authors: MJ
authors: Hamel
authors: Simon
authors: S
authors: Kariuki
authors: Chris
authors: C
authors: Odero
authors: Martina
authors: M
authors: Oneko
authors: Kephas
authors: K
authors: Otieno
authors: Norbert
authors: N
authors: Awino
authors: Jackton
authors: J
authors: Omoto
authors: John
authors: J
authors: Williamson
authors: Vincent
authors: V
authors: Muturi-Kioi
authors: Kayla F
authors: KF
authors: Laserson
authors: Laurence
authors: L
authors: Slutsker
authors: Walter
authors: W
authors: Otieno
authors: Lucas
authors: L
authors: Otieno
authors: Otsyula
authors: O
authors: Nekoye
authors: Stacey
authors: S
authors: Gondi
authors: Allan
authors: A
authors: Otieno
authors: Bernhards
authors: B
authors: Ogutu
authors: Ruth
authors: R
authors: Wasuna
authors: Victorine
authors: V
authors: Owira
authors: David
authors: D
authors: Jones
authors: Agnes Akoth
authors: AA
authors: Onyango
authors: Patricia
authors: P
authors: Njuguna
authors: Roma
authors: R
authors: Chilengi
authors: Pauline
authors: P
authors: Akoo
authors: Christine
authors: C
authors: Kerubo
authors: Jesse
authors: J
authors: Gitaka
authors: Charity
authors: C
authors: Maingi
authors: Trudie
authors: T
authors: Lang
authors: Ally
authors: A
authors: Olotu
authors: Benjamin
authors: B
authors: Tsofa
authors: Philip
authors: P
authors: Bejon
authors: Norbert
authors: N
authors: Peshu
authors: Kevin
authors: K
authors: Marsh
authors: Seth
authors: S
authors: Owusu-Agyei
authors: Kwaku Poku
authors: KP
authors: Asante
authors: Kingsley
authors: K
authors: Osei-Kwakye
authors: Owusu
authors: O
authors: Boahen
authors: Samuel
authors: S
authors: Ayamba
authors: Kingsley
authors: K
authors: Kayan
authors: Ruth
authors: R
authors: Owusu-Ofori
authors: David
authors: D
authors: Dosoo
authors: Isaac
authors: I
authors: Asante
authors: George
authors: G
authors: Adjei
authors: George
authors: G
authors: Adjei
authors: Daniel
authors: D
authors: Chandramohan
authors: Brian
authors: B
authors: Greenwood
authors: John
authors: J
authors: Lusingu
authors: Samwel
authors: S
authors: Gesase
authors: Anangisye
authors: A
authors: Malabeja
authors: Omari
authors: O
authors: Abdul
authors: Hassan
authors: H
authors: Kilavo
authors: Coline
authors: C
authors: Mahende
authors: Edwin
authors: E
authors: Liheluka
authors: Martha
authors: M
authors: Lemnge
authors: Thor
authors: T
authors: Theander
authors: Chris
authors: C
authors: Drakeley
authors: Daniel
authors: D
authors: Ansong
authors: Tsiri
authors: T
authors: Agbenyega
authors: Samuel
authors: S
authors: Adjei
authors: Harry Owusu
authors: HO
authors: Boateng
authors: Theresa
authors: T
authors: Rettig
authors: John
authors: J
authors: Bawa
authors: Justice
authors: J
authors: Sylverken
authors: David
authors: D
authors: Sambian
authors: Alex
authors: A
authors: Agyekum
authors: Larko
authors: L
authors: Owusu
authors: Francis
authors: F
authors: Martinson
authors: Irving
authors: I
authors: Hoffman
authors: Tisungane
authors: T
authors: Mvalo
authors: Portia
authors: P
authors: Kamthunzi
authors: Ruthendo
authors: R
authors: Nkomo
authors: Albans
authors: A
authors: Msika
authors: Allan
authors: A
authors: Jumbe
authors: Nelecy
authors: N
authors: Chome
authors: Dalitso
authors: D
authors: Nyakuipa
authors: Joseph
authors: J
authors: Chintedza
authors: W Ripley
authors: WR
authors: Ballou
authors: Myriam
authors: M
authors: Bruls
authors: Joe
authors: J
authors: Cohen
authors: Yolanda
authors: Y
authors: Guerra
authors: Erik
authors: E
authors: Jongert
authors: Didier
authors: D
authors: Lapierre
authors: Amanda
authors: A
authors: Leach
authors: Marc
authors: M
authors: Lievens
authors: Opokua
authors: O
authors: Ofori-Anyinam
authors: Johan
authors: J
authors: Vekemans
authors: Terrell
authors: T
authors: Carter
authors: Didier
authors: D
authors: Leboulleux
authors: Christian
authors: C
authors: Loucq
authors: Afiya
authors: A
authors: Radford
authors: Barbara
authors: B
authors: Savarese
authors: David
authors: D
authors: Schellenberg
authors: Marla
authors: M
authors: Sillman
authors: Preeti
authors: P
authors: Vansadia
mesh_terms: D000349:Africa; D000367:Age Factors; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007223:Infant; D057194:Intention to Treat Analysis; D017780:Malaria Vaccines / Q000009:adverse effects / Q000276:immunology; D016778:Malaria, Falciparum / Q000453:epidemiology / Q000469:parasitology / Q000517:prevention & control*; D008297:Male; D008581:Meningitis / Q000453:epidemiology / Q000209:etiology; D059208:Parasite Load; D010963:Plasmodium falciparum / Q000276:immunology / Q000302:isolation & purification; D012640:Seizures / Q000453:epidemiology / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D017780:Malaria Vaccines