TY - JOUR
T1 - Safety, tolerability, and immunogenicity of V114 pneumococcal vaccine compared with PCV13 in a 2+1 regimen in healthy infants
T2 - A phase III study (PNEU-PED-EU-2)
AU - Benfield, Thomas
AU - Rämet, Mika
AU - Valentini, Piero
AU - Seppä, Ilkka
AU - Dagan, Ron
AU - Richmond, Peter
AU - Mercer, Swati
AU - Churchill, Clay
AU - Lupinacci, Robert
AU - McFetridge, Richard
AU - Park, Jun
AU - Wittke, Frederick
AU - Banniettis, Natalie
AU - Musey, Luwy
AU - Bickham, Kara
AU - Kaminski, Janusz
N1 - Funding Information:
The authors would like to thank the participants, their families, and all investigators involved in the PNEU-PED-EU-2 study. Principal investigators for this study can be found in Supplemental Table 8 . Medical writing support, including assisting authors with the development of the outline and initial draft and incorporation of comments, was provided by Rachel Wright, PhD, and editorial support was provided by Ian Norton, PhD, all of Scion, London, according to Good Publication Practice guidelines (Link). This assistance was funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Funding Information:
The authors would like to thank the participants, their families, and all investigators involved in the PNEU-PED-EU-2 study. Principal investigators for this study can be found in Supplemental Table 8. Medical writing support, including assisting authors with the development of the outline and initial draft and incorporation of comments, was provided by Rachel Wright, PhD, and editorial support was provided by Ian Norton, PhD, all of Scion, London, according to Good Publication Practice guidelines (Link). This assistance was funded by Merck Sharp & Dohme LLC. a subsidiary of Merck & Co. Inc. Rahway, NJ, USA. Funding for this research was provided by Merck Sharp & Dohme LLC. a subsidiary of Merck & Co. Inc. Rahway, NJ, USA. The data sharing policy, including restrictions, of Merck Sharp & Dohme LLC. a subsidiary of Merck & Co. Inc. Rahway, NJ, USA is available athttps://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study data can be submitted through the EngageZone site or via email to [email protected].
Publisher Copyright:
© 2023 Merck Sharp & Dohme LLC,
PY - 2023/4/6
Y1 - 2023/4/6
N2 - Background: This phase III study evaluated safety, tolerability, and immunogenicity of V114 (15-valent pneumococcal conjugate vaccine) in healthy infants. V114 contains all 13 serotypes in PCV13 and additional serotypes 22F and 33F. Methods: Healthy infants were randomized to two primary doses and one toddler dose (2+1 regimen) of V114 or PCV13 at 3, 5, and 12 months of age; diphtheria, tetanus, pertussis (DTaP), inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib), hepatitis B (HepB) vaccine was administered concomitantly. Adverse events (AEs) were collected on Days 1–14 following each vaccination. Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured 30 days post-primary series, immediately prior to toddler dose, and 30 days post-toddler dose. Primary objectives included non-inferiority of V114 to PCV13 for 13 shared serotypes and superiority of V114 to PCV13 for serotypes 22F and 33F. Results: 1191 healthy infants were randomized to V114 (n = 595) or PCV13 (n = 596). Proportions of participants with solicited AEs and serious AEs were comparable between groups. V114 met non-inferiority criteria for 13 shared serotypes, based on difference in proportions with serotype-specific IgG ≥0.35 μg/mL (lower bound of two-sided 95% confidence interval [CI] >−10.0) and IgG geometric mean concentration (GMC) ratios (lower bound of two-sided 95% CI >0.5) at 30 days post-toddler dose. V114 met superiority criteria for serotypes 22F and 33F, based on response rates (lower bound of two-sided 95% CI >10.0) and IgG GMC ratios (lower bound of two-sided 95% CI >2.0) at 30 days post-toddler dose. Antibody responses to DTaP-IPV-Hib-HepB met non-inferiority criteria, based on antigen-specific response rates. Conclusion: A two-dose primary series plus toddler dose of V114 was well-tolerated in healthy infants. Compared with PCV13, V114 provided non-inferior immune responses to 13 shared serotypes and superior immune responses to additional serotypes 22F and 33F.
AB - Background: This phase III study evaluated safety, tolerability, and immunogenicity of V114 (15-valent pneumococcal conjugate vaccine) in healthy infants. V114 contains all 13 serotypes in PCV13 and additional serotypes 22F and 33F. Methods: Healthy infants were randomized to two primary doses and one toddler dose (2+1 regimen) of V114 or PCV13 at 3, 5, and 12 months of age; diphtheria, tetanus, pertussis (DTaP), inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib), hepatitis B (HepB) vaccine was administered concomitantly. Adverse events (AEs) were collected on Days 1–14 following each vaccination. Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured 30 days post-primary series, immediately prior to toddler dose, and 30 days post-toddler dose. Primary objectives included non-inferiority of V114 to PCV13 for 13 shared serotypes and superiority of V114 to PCV13 for serotypes 22F and 33F. Results: 1191 healthy infants were randomized to V114 (n = 595) or PCV13 (n = 596). Proportions of participants with solicited AEs and serious AEs were comparable between groups. V114 met non-inferiority criteria for 13 shared serotypes, based on difference in proportions with serotype-specific IgG ≥0.35 μg/mL (lower bound of two-sided 95% confidence interval [CI] >−10.0) and IgG geometric mean concentration (GMC) ratios (lower bound of two-sided 95% CI >0.5) at 30 days post-toddler dose. V114 met superiority criteria for serotypes 22F and 33F, based on response rates (lower bound of two-sided 95% CI >10.0) and IgG GMC ratios (lower bound of two-sided 95% CI >2.0) at 30 days post-toddler dose. Antibody responses to DTaP-IPV-Hib-HepB met non-inferiority criteria, based on antigen-specific response rates. Conclusion: A two-dose primary series plus toddler dose of V114 was well-tolerated in healthy infants. Compared with PCV13, V114 provided non-inferior immune responses to 13 shared serotypes and superior immune responses to additional serotypes 22F and 33F.
KW - Child
KW - Clinical trial
KW - Infant
KW - Pneumococcal infections
KW - Pneumococcal vaccines
UR - http://www.scopus.com/inward/record.url?scp=85149963824&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2023.02.041
DO - 10.1016/j.vaccine.2023.02.041
M3 - Article
C2 - 36841723
AN - SCOPUS:85149963824
SN - 0264-410X
VL - 41
SP - 2456
EP - 2465
JO - Vaccine
JF - Vaccine
IS - 15
ER -
