TY - JOUR
T1 - Corrigendum to “A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1)” [Vaccine 41 (2023) 3387–3398, (S0264410X23004280), (10.1016/j.vaccine.2023.04.036)]
AU - on behalf of the V114-025 PNEU-PED-EU-1 study group
AU - Martinon-Torres, Federico
AU - Wysocki, Jacek
AU - Szenborn, Leszek
AU - Carmona-Martinez, Alfonso
AU - Poder, Airi
AU - Dagan, Ron
AU - Richmond, Peter
AU - Gilbert, Christopher
AU - Trudel, Marie Chantale
AU - Flores, Sheryl
AU - Lupinacci, Robert
AU - McFetridge, Richard
AU - Wiedmann, Richard T.
AU - Chen, Qiuxu
AU - Gerrits, Han
AU - Banniettis, Natalie
AU - Musey, Luwy
AU - Bickham, Kara
AU - Kaminski, Janusz
N1 - Publisher Copyright:
© 2024
PY - 2025/2/27
Y1 - 2025/2/27
N2 - The authors regret the incorrect publication of the proportion of participants with one or more injection-site adverse event (AE) in the V114 group in Table 2. However, it should be noted that the published n, number of participants, was correct. In addition, some data in the supplementary tables were published incorrectly. The proportion of participants in the V114 group with one or more AE following dose 2 of primary series in Supplementary Table S2 was incorrect, although the number of participants was correct. The interpretations regarding these data are unaffected. The number of participants in the V114 group with irritability lasting between 5 and 10 days in Supplementary Table S4 was incorrectly published. The percentage for this group is correct and the interpretations regarding these data are unaffected. The upper bounds of the confidence intervals for geometric mean concentration (GMC) ratios for serotypes 1 and 18C in Supplementary Table S7 were published incorrectly. The p-values for these comparisons were correct and, therefore, the interpretations need not change. There was an editorial error in Supplementary Table S9, in which the observed response percentage for serotype 1 in the V114 group was missing a decimal point. The data reported are unaffected by this error. The observed responses for serotype 19F in the 13-valent pneumococcal conjugate vaccine (PCV13) group in Supplementary Table S10 were also published incorrectly. The number of participants was published correctly, and the interpretations based on these data are reported accurately. The n, number of participants, in the serotype 6A PCV13 group in Supplementary Table S11 was incorrectly published. Observed response values are published correctly, as are all statements regarding these data. Lastly, the percentage point difference estimate between V114 and PCV13 groups for serotype 19A was incorrectly published in the participants with gestational age ≥37 weeks section of Supplementary Table S12. The text describing these data is accurate and interpretation remains unaffected. The authors would like to apologise for any inconvenience caused and confirm that this does not change the scientific conclusions of the article in any way. Incorrect Table 2 Section. Proportions of participants with AEs following any dose of PCV. [Table presented] Correct Table 2 Section. Proportion of participants with AEs following any dose of PCV. [Table presented] Incorrect Supplementary Table S2. Proportion of participants with AEs following each dose of PCV (dose 1 of primary series, dose 2 of primary series, and toddler dose). Following dose 2 of primary series [Table presented] Correct Supplementary Table S2. Proportion of participants with AEs following each dose of PCV (dose 1 of primary series, dose 2 of primary series, and toddler dose). Following dose 2 of primary series [Table presented] Incorrect Supplementary Table S4. Proportions of participants with solicited AEs following any dose of PCV by duration. [Table presented] Correct Supplementary Table S4. Proportions of participants with solicited AEs following any dose of PCV by duration. [Table presented] Incorrect Supplementary Table S7. Serotype-specific anti-PnP IgG GMCs at 30 days PTD. [Table presented] Correct Supplementary Table S7. Serotype-specific anti-PnP IgG GMCs at 30 days PTD. [Table presented] Incorrect Supplementary Table S9 Section. Serotype-specific OPA response rates at 30 days PTD. [Table presented] Correct Supplementary Table S9 Section. Serotype-specific OPA response rates at 30 days PTD. [Table presented] Incorrect Supplementary Table S10. Serotype-specific OPA GMTs over time. [Table presented] Correct Supplementary Table S10. Serotype-specific OPA GMTs over time. [Table presented] Incorrect Supplementary Table S11. Serotype-specific IgG GMCs over time. [Table presented] Correct Supplementary Table S11. Serotype-specific IgG GMCs over time. [Table presented] Incorrect Supplementary Table S12 Section. Serotype-specific anti-PnP IgG response rates at 30 days PTD for participants with gestational age <37 weeks versus ≥37 weeks. Participants with gestational age ≥37 weeks. [Table presented] Correct Supplementary Table S12 Section. Serotype-specific anti-PnP IgG response rates at 30 days PTD for participants with gestational age <37 weeks versus ≥37 weeks. Participants with gestational age ≥37 weeks.
AB - The authors regret the incorrect publication of the proportion of participants with one or more injection-site adverse event (AE) in the V114 group in Table 2. However, it should be noted that the published n, number of participants, was correct. In addition, some data in the supplementary tables were published incorrectly. The proportion of participants in the V114 group with one or more AE following dose 2 of primary series in Supplementary Table S2 was incorrect, although the number of participants was correct. The interpretations regarding these data are unaffected. The number of participants in the V114 group with irritability lasting between 5 and 10 days in Supplementary Table S4 was incorrectly published. The percentage for this group is correct and the interpretations regarding these data are unaffected. The upper bounds of the confidence intervals for geometric mean concentration (GMC) ratios for serotypes 1 and 18C in Supplementary Table S7 were published incorrectly. The p-values for these comparisons were correct and, therefore, the interpretations need not change. There was an editorial error in Supplementary Table S9, in which the observed response percentage for serotype 1 in the V114 group was missing a decimal point. The data reported are unaffected by this error. The observed responses for serotype 19F in the 13-valent pneumococcal conjugate vaccine (PCV13) group in Supplementary Table S10 were also published incorrectly. The number of participants was published correctly, and the interpretations based on these data are reported accurately. The n, number of participants, in the serotype 6A PCV13 group in Supplementary Table S11 was incorrectly published. Observed response values are published correctly, as are all statements regarding these data. Lastly, the percentage point difference estimate between V114 and PCV13 groups for serotype 19A was incorrectly published in the participants with gestational age ≥37 weeks section of Supplementary Table S12. The text describing these data is accurate and interpretation remains unaffected. The authors would like to apologise for any inconvenience caused and confirm that this does not change the scientific conclusions of the article in any way. Incorrect Table 2 Section. Proportions of participants with AEs following any dose of PCV. [Table presented] Correct Table 2 Section. Proportion of participants with AEs following any dose of PCV. [Table presented] Incorrect Supplementary Table S2. Proportion of participants with AEs following each dose of PCV (dose 1 of primary series, dose 2 of primary series, and toddler dose). Following dose 2 of primary series [Table presented] Correct Supplementary Table S2. Proportion of participants with AEs following each dose of PCV (dose 1 of primary series, dose 2 of primary series, and toddler dose). Following dose 2 of primary series [Table presented] Incorrect Supplementary Table S4. Proportions of participants with solicited AEs following any dose of PCV by duration. [Table presented] Correct Supplementary Table S4. Proportions of participants with solicited AEs following any dose of PCV by duration. [Table presented] Incorrect Supplementary Table S7. Serotype-specific anti-PnP IgG GMCs at 30 days PTD. [Table presented] Correct Supplementary Table S7. Serotype-specific anti-PnP IgG GMCs at 30 days PTD. [Table presented] Incorrect Supplementary Table S9 Section. Serotype-specific OPA response rates at 30 days PTD. [Table presented] Correct Supplementary Table S9 Section. Serotype-specific OPA response rates at 30 days PTD. [Table presented] Incorrect Supplementary Table S10. Serotype-specific OPA GMTs over time. [Table presented] Correct Supplementary Table S10. Serotype-specific OPA GMTs over time. [Table presented] Incorrect Supplementary Table S11. Serotype-specific IgG GMCs over time. [Table presented] Correct Supplementary Table S11. Serotype-specific IgG GMCs over time. [Table presented] Incorrect Supplementary Table S12 Section. Serotype-specific anti-PnP IgG response rates at 30 days PTD for participants with gestational age <37 weeks versus ≥37 weeks. Participants with gestational age ≥37 weeks. [Table presented] Correct Supplementary Table S12 Section. Serotype-specific anti-PnP IgG response rates at 30 days PTD for participants with gestational age <37 weeks versus ≥37 weeks. Participants with gestational age ≥37 weeks.
UR - http://www.scopus.com/inward/record.url?scp=85215432863&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2024.126628
DO - 10.1016/j.vaccine.2024.126628
M3 - Comment/debate
C2 - 39837003
AN - SCOPUS:85215432863
SN - 0264-410X
VL - 48
JO - Vaccine
JF - Vaccine
M1 - 126628
ER -