PMID- 34525007
OWN - NLM
STAT- MEDLINE
DCOM- 20220119
LR  - 20230912
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Print)
IS  - 0891-3668 (Linking)
VI  - 40
IP  - 10
DP  - 2021 Oct 1
TI  - Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in 
      Healthy Infants in the United States.
PG  - 944-951
LID - 10.1097/INF.0000000000003277 [doi]
AB  - BACKGROUND: The development and widespread use of pneumococcal conjugate vaccines 
      (PCVs) substantially reduced the global burden of pneumococcal disease. Expanding 
      the serotypes covered by PCVs may further reduce disease burden. A 20-valent PCV 
      (PCV20) has been developed to add coverage for 7 additional serotypes (8, 10A, 
      11A, 12F, 15B, 22F and 33F) to those in the existing 13-valent PCV (PCV13). This 
      phase 2 study evaluated the safety, tolerability and immunogenicity of PCV20 in 
      healthy US infants. METHODS: In this randomized, active-controlled, double-blind 
      study, 460 infants were randomized 1:1 to receive a 4-dose series of either PCV20 
      or PCV13 at 2, 4, 6 and 12 months of age. Solicited local reactions and systemic 
      events, adverse events (AEs) and serious AEs were recorded. Immunogenicity was 
      assessed by measuring serotype-specific IgG concentrations and opsonophagocytic 
      activity titers at 1 month after Dose 3, before Dose 4 and 1 month after Dose 4. 
      RESULTS: Of 460 infants, 82.8% completed the 1-month visit after Dose 4. Local 
      reactions and systemic events were mostly mild to moderate in severity and 
      similar between the PCV20 and PCV13 groups. Treatment-related AEs were uncommon, 
      with no related serious AEs or deaths reported. IgG and opsonophagocytic activity 
      responses elicited by PCV20 were robust and demonstrated a booster response after 
      Dose 4. CONCLUSIONS: Administration of PCV20 in US infants was well tolerated, 
      with a safety profile similar to PCV13, and induced robust serotype-specific 
      immune responses. These findings support continued development of PCV20 in the 
      pediatric population.
CI  - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Senders, Shelly
AU  - Senders S
AD  - From the Senders Pediatrics, South Euclid, Ohio.
FAU - Klein, Nicola P
AU  - Klein NP
AD  - Kaiser Permanente Vaccine Study Center, Oakland, California.
FAU - Lamberth, Erik
AU  - Lamberth E
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Thompson, Allison
AU  - Thompson A
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York.
FAU - Drozd, Jelena
AU  - Drozd J
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Trammel, James
AU  - Trammel J
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Peng, Yahong
AU  - Peng Y
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Giardina, Peter C
AU  - Giardina PC
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York.
FAU - Jansen, Kathrin U
AU  - Jansen KU
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York.
FAU - Gruber, William C
AU  - Gruber WC
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York.
FAU - Scott, Daniel A
AU  - Scott DA
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Watson, Wendy
AU  - Watson W
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
LA  - eng
SI  - ClinicalTrials.gov/NCT03512288
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Antibodies, Bacterial/*blood
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Immunoglobulin G/blood
MH  - Infant
MH  - Male
MH  - Pneumococcal Infections/prevention & control
MH  - Pneumococcal Vaccines/administration & dosage/classification/*immunology
MH  - *Serogroup
MH  - Streptococcus pneumoniae/classification/immunology
MH  - United States
MH  - Vaccines, Conjugate/administration & dosage/immunology
PMC - PMC8443440
EDAT- 2021/09/16 06:00
MHDA- 2022/01/20 06:00
PMCR- 2021/09/16
CRDT- 2021/09/15 17:17
PHST- 2021/09/15 17:17 [entrez]
PHST- 2021/09/16 06:00 [pubmed]
PHST- 2022/01/20 06:00 [medline]
PHST- 2021/09/16 00:00 [pmc-release]
AID - 00006454-202110000-00016 [pii]
AID - 10.1097/INF.0000000000003277 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 
      10.1097/INF.0000000000003277.