PMID- 34726574
OWN - NLM
STAT- MEDLINE
DCOM- 20220418
LR  - 20220531
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 18
IP  - 1
DP  - 2022 Dec 31
TI  - Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal 
      conjugate vaccine, administered concomitantly with influenza vaccine in healthy 
      adults aged >/=50 years: a randomized phase 3 trial (PNEU-FLU).
PG  - 1-14
LID - 10.1080/21645515.2021.1976581 [doi]
AB  - Streptococcus pneumoniae and influenza viruses are associated with significant 
      morbidity and mortality in older adults. Concomitant vaccination against these 
      agents reduces hospitalization and mortality rates. This phase 3 trial evaluated 
      safety, tolerability, and immunogenicity of concomitant and non-concomitant 
      administration of V114, a 15-valent pneumococcal conjugate vaccine containing 
      serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F, and 
      quadrivalent inactivated influenza vaccine (QIV), in healthy adults aged 
      >/=50 years. Participants (N = 1,200) were randomized 1:1 to receive either V114 
      administered concomitantly with QIV (concomitant group) or QIV plus placebo 
      (non-concomitant group) on Day 1, followed by placebo (concomitant group) or V114 
      (non-concomitant group) 30 days later. Randomization was stratified by age and 
      history of pneumococcal polysaccharide vaccine receipt. Overall, 426 (71.0%) and 
      438 (73.5%) participants in the concomitant and non-concomitant groups 
      experienced solicited injection-site adverse events (AEs); 278 (46.3%) and 300 
      (50.3%) reported solicited systemic AEs. Most solicited AEs were mild or moderate 
      in severity and of short duration. Non-inferiority for pneumococcal- and 
      influenza-specific antibody responses (lower bound 95% confidence interval of 
      opsonophagocytic activity [OPA] and hemagglutination inhibition geometric mean 
      titers [GMTs] ratios >/=0.5) was demonstrated for concomitant versus 
      non-concomitant administration for all 15 pneumococcal serotypes and all four 
      influenza strains. Consistent with previous studies, a trend was observed toward 
      lower pneumococcal OPA GMTs in the concomitant versus the non-concomitant group. 
      V114 administered concomitantly with QIV is generally well tolerated and 
      immunologically non-inferior to non-concomitant administration, supporting 
      coadministration of both vaccines.
FAU - Severance, Randall
AU  - Severance R
AUID- ORCID: 0000-0003-1580-5410
AD  - Synexus Clinical Research, Chandler, AZ, USA.
FAU - Schwartz, Howard
AU  - Schwartz H
AD  - Research Centers of America, Hollywood, FL, USA.
FAU - Dagan, Ron
AU  - Dagan R
AUID- ORCID: 0000-0002-8888-1046
AD  - Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er Sheva, 
      Israel.
FAU - Connor, Laurie
AU  - Connor L
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Li, Jianing
AU  - Li J
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Pedley, Alison
AU  - Pedley A
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Hartzel, Jonathan
AU  - Hartzel J
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Sterling, Tina M
AU  - Sterling TM
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Nolan, Katrina M
AU  - Nolan KM
AUID- ORCID: 0000-0001-5030-7930
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Tamms, Gretchen M
AU  - Tamms GM
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Musey, Luwy K
AU  - Musey LK
AUID- ORCID: 0000-0001-5484-7037
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Buchwald, Ulrike K
AU  - Buchwald UK
AUID- ORCID: 0000-0002-6671-0115
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20211102
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Aged
MH  - Antibodies, Bacterial
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - *Influenza Vaccines/administration & dosage/adverse effects
MH  - Influenza, Human/prevention & control
MH  - Middle Aged
MH  - Pneumococcal Infections/prevention & control
MH  - *Pneumococcal Vaccines/administration & dosage/adverse effects
MH  - Streptococcus pneumoniae/immunology
MH  - Vaccines, Combined/adverse effects
MH  - Vaccines, Conjugate/administration & dosage/adverse effects
PMC - PMC8920144
OTO - NOTNLM
OT  - Pneumococcal conjugate vaccine
OT  - concomitant
OT  - immunogenicity
OT  - influenza vaccine
OT  - safety
EDAT- 2021/11/03 06:00
MHDA- 2022/04/19 06:00
PMCR- 2021/11/02
CRDT- 2021/11/02 12:17
PHST- 2021/11/03 06:00 [pubmed]
PHST- 2022/04/19 06:00 [medline]
PHST- 2021/11/02 12:17 [entrez]
PHST- 2021/11/02 00:00 [pmc-release]
AID - 1976581 [pii]
AID - 10.1080/21645515.2021.1976581 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2022 Dec 31;18(1):1-14. doi: 
      10.1080/21645515.2021.1976581. Epub 2021 Nov 2.