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Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older.

Abstract Improved influenza vaccines are needed to control seasonal epidemics. This trial compared the protective efficacy in older adults of a quadrivalent, recombinant influenza vaccine (RIV4) with a standard-dose, egg-grown, quadrivalent, inactivated influenza vaccine (IIV4) during the A/H3N2-predominant 2014-2015 influenza season, when antigenic mismatch between circulating and vaccine influenza strains resulted in the reduced effectiveness of many licensed vaccines.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title the new england journal of medicine
Publication Year Start




PMID- 28636855
OWN - NLM
STAT- MEDLINE
DA  - 20170621
DCOM- 20170629
LR  - 20170629
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 376
IP  - 25
DP  - 2017 Jun 22
TI  - Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older.
PG  - 2427-2436
LID - 10.1056/NEJMoa1608862 [doi]
AB  - BACKGROUND: Improved influenza vaccines are needed to control seasonal epidemics.
      This trial compared the protective efficacy in older adults of a quadrivalent,
      recombinant influenza vaccine (RIV4) with a standard-dose, egg-grown,
      quadrivalent, inactivated influenza vaccine (IIV4) during the A/H3N2-predominant 
      2014-2015 influenza season, when antigenic mismatch between circulating and
      vaccine influenza strains resulted in the reduced effectiveness of many licensed 
      vaccines. METHODS: We conducted a randomized, double-blind, multicenter trial of 
      RIV4 (45 mug of recombinant hemagglutinin [HA] per strain, 180 mug of protein per
      dose) versus standard-dose IIV4 (15 mug of HA per strain, 60 mug of protein per
      dose) to compare the relative vaccine efficacy against reverse-transcriptase
      polymerase-chain-reaction (RT-PCR)-confirmed, protocol-defined, influenza-like
      illness caused by any influenza strain starting 14 days or more after vaccination
      in adults who were 50 years of age or older. The diagnosis of influenza infection
      was confirmed by means of RT-PCR assay and culture of nasopharyngeal swabs
      obtained from participants with symptoms of an influenza-like illness. The
      primary end point was RT-PCR-confirmed, protocol defined, influenza-like illness 
      between 14 days or more after vaccination and the end of the influenza season.
      RESULTS: A total of 9003 participants were enrolled and underwent randomization; 
      8855 (98.4%) received a trial vaccine and underwent an efficacy follow-up (the
      modified intention-to-treat population), and 8604 (95.6%) completed the
      per-protocol follow-up (the modified per-protocol population). Among RIV4
      recipients, the RT-PCR-confirmed influenza attack rate was 2.2% (96 cases among
      4303 participants) in the modified per-protocol population and 2.2% (96 cases
      among 4427 participants) in the modified intention-to-treat population. Among
      IIV4 recipients, the attack rate was 3.2% (138 cases among 4301 participants) in 
      the modified per-protocol population and 3.1% (138 cases among 4428 participants)
      in the modified intention-to-treat population. A total of 181 cases of influenza 
      A/H3N2, 47 cases of influenza B, and 6 cases of nonsubtypeable influenza A were
      detected. The probability of influenza-like illness was 30% lower with RIV4 than 
      with IIV4 (95% confidence interval, 10 to 47; P=0.006) and satisfied prespecified
      criteria for the primary noninferiority analysis and an exploratory superiority
      analysis of RIV4 over IIV4. The safety profiles of the vaccines were similar.
      CONCLUSIONS: RIV4 provided better protection than standard-dose IIV4 against
      confirmed influenza-like illness among older adults. (Funded by Protein Sciences;
      ClinicalTrials.gov number, NCT02285998 .).
FAU - Dunkle, Lisa M
AU  - Dunkle LM
AD  - From Protein Sciences, Meriden, CT (L.M.D., R.I., M.M.J.C.); Biologics
      Consulting, Rockville, MD (P.P.); independent consultant, San Antonio, TX
      (K.L.G.); Jean Brown Research, Salt Lake City (D.M.); and Callahan Associates,
      San Diego, CA (J.C.).
FAU - Izikson, Ruvim
AU  - Izikson R
AD  - From Protein Sciences, Meriden, CT (L.M.D., R.I., M.M.J.C.); Biologics
      Consulting, Rockville, MD (P.P.); independent consultant, San Antonio, TX
      (K.L.G.); Jean Brown Research, Salt Lake City (D.M.); and Callahan Associates,
      San Diego, CA (J.C.).
FAU - Patriarca, Peter
AU  - Patriarca P
AD  - From Protein Sciences, Meriden, CT (L.M.D., R.I., M.M.J.C.); Biologics
      Consulting, Rockville, MD (P.P.); independent consultant, San Antonio, TX
      (K.L.G.); Jean Brown Research, Salt Lake City (D.M.); and Callahan Associates,
      San Diego, CA (J.C.).
FAU - Goldenthal, Karen L
AU  - Goldenthal KL
AD  - From Protein Sciences, Meriden, CT (L.M.D., R.I., M.M.J.C.); Biologics
      Consulting, Rockville, MD (P.P.); independent consultant, San Antonio, TX
      (K.L.G.); Jean Brown Research, Salt Lake City (D.M.); and Callahan Associates,
      San Diego, CA (J.C.).
FAU - Muse, Derek
AU  - Muse D
AD  - From Protein Sciences, Meriden, CT (L.M.D., R.I., M.M.J.C.); Biologics
      Consulting, Rockville, MD (P.P.); independent consultant, San Antonio, TX
      (K.L.G.); Jean Brown Research, Salt Lake City (D.M.); and Callahan Associates,
      San Diego, CA (J.C.).
FAU - Callahan, Janice
AU  - Callahan J
AD  - From Protein Sciences, Meriden, CT (L.M.D., R.I., M.M.J.C.); Biologics
      Consulting, Rockville, MD (P.P.); independent consultant, San Antonio, TX
      (K.L.G.); Jean Brown Research, Salt Lake City (D.M.); and Callahan Associates,
      San Diego, CA (J.C.).
FAU - Cox, Manon M J
AU  - Cox MMJ
AD  - From Protein Sciences, Meriden, CT (L.M.D., R.I., M.M.J.C.); Biologics
      Consulting, Rockville, MD (P.P.); independent consultant, San Antonio, TX
      (K.L.G.); Jean Brown Research, Salt Lake City (D.M.); and Callahan Associates,
      San Diego, CA (J.C.).
CN  - PSC12 Study Team
LA  - eng
SI  - ClinicalTrials.gov/NCT02285998
PT  - Clinical Trial, Phase III
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
RN  - 0 (Vaccines, Synthetic)
SB  - AIM
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Influenza A Virus, H3N2 Subtype/isolation & purification
MH  - Influenza A virus/isolation & purification
MH  - Influenza B virus/isolation & purification
MH  - Influenza Vaccines/adverse effects/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Nasopharynx/virology
MH  - Proportional Hazards Models
MH  - Treatment Outcome
MH  - Vaccines, Inactivated/immunology
MH  - Vaccines, Synthetic/immunology
IR  - Bauer GH
FIR - Bauer, G H
IR  - Borders J
FIR - Borders, J
IR  - Bradley PS
FIR - Bradley, P S
IR  - Bravo E
FIR - Bravo, E
IR  - Cervantes J
FIR - Cervantes, J
IR  - Chu L
FIR - Chu, L
IR  - Cifuentes E
FIR - Cifuentes, E
IR  - Connery L
FIR - Connery, L
IR  - Davis M
FIR - Davis, M
IR  - Douglas WG
FIR - Douglas, W G
IR  - Dushkin H
FIR - Dushkin, H
IR  - Ensz DJ
FIR - Ensz, D J
IR  - Epstein R
FIR - Epstein, R
IR  - Ervin J
FIR - Ervin, J
IR  - Essink B
FIR - Essink, B
IR  - Griffin C
FIR - Griffin, C
IR  - Herrington D
FIR - Herrington, D
IR  - Jacqmein J
FIR - Jacqmein, J
IR  - Kravitz A
FIR - Kravitz, A
IR  - Lesh K
FIR - Lesh, K
IR  - McCartney M
FIR - McCartney, M
IR  - Miel E
FIR - Miel, E
IR  - Mills R
FIR - Mills, R
IR  - Mirkil VJ
FIR - Mirkil, V J
IR  - Muse D
FIR - Muse, D
IR  - Patel S
FIR - Patel, S
IR  - Poling TL
FIR - Poling, T L
IR  - Rankin B
FIR - Rankin, B
IR  - Rizos D
FIR - Rizos, D
IR  - Rosen JR
FIR - Rosen, J R
IR  - Saleh J
FIR - Saleh, J
IR  - Seger W
FIR - Seger, W
IR  - Sharp S
FIR - Sharp, S
IR  - Studdard H
FIR - Studdard, H
IR  - Turner M
FIR - Turner, M
IR  - Tyson T
FIR - Tyson, T
IR  - Varano S
FIR - Varano, S
IR  - Vrbicky K
FIR - Vrbicky, K
IR  - White A
FIR - White, A
IR  - Wilson J
FIR - Wilson, J
IR  - Wombolt D
FIR - Wombolt, D
EDAT- 2017/06/22 06:00
MHDA- 2017/07/01 06:00
CRDT- 2017/06/22 06:00
AID - 10.1056/NEJMoa1608862 [doi]
PST - ppublish
SO  - N Engl J Med. 2017 Jun 22;376(25):2427-2436. doi: 10.1056/NEJMoa1608862.