336 A phase 3, multicenter, randomised, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of v114 in healthy infants (PNEU-PED)

Lupinacci R., Rupp R., Wittawatmongkol O., Jones J., Quiñones J., Ulukol B., ...Daha Fazla

Royal College of Paediatrics and Child Health, Abstracts of the RCPCH Conference, Liverpool, 28–30 June 2022, Liverpool, İngiltere, 28 - 30 Haziran 2022, ss.204

  • Yayın Türü: Bildiri / Özet Bildiri
  • Doi Numarası: 10.1136/archdischild-2022-rcpch.326
  • Basıldığı Şehir: Liverpool
  • Basıldığı Ülke: İngiltere
  • Sayfa Sayıları: ss.204
  • Ankara Üniversitesi Adresli: Evet

Özet

A PHASE 3, MULTICENTER, RANDOMISED, DOUBLEBLIND, ACTIVE-COMPARATOR-CONTROLLED STUDY TO

EVALUATE THE SAFETY, TOLERABILITY, AND

IMMUNOGENICITY OF A 4-DOSE REGIMEN OF V114 IN

HEALTHY INFANTS (PNEU-PED)

1

Robert Lupinacci, 2

Richard Rupp, 3

Orasri Wittawatmongkol, 4

Jake Jones, 5

Jeffrey Quiñones,

6

Betul Ulukol, 7

Ron Dagan, 8

Peter Richmond, 1

Jon Stek, 1

Lizbeth Romero,

1

Sandra Koseoglu, 1

Gretchen Tamms, 1

Richard McFetridge, 1

Jianing Li, 1

Kyeongmi Cheon,

1

Luwy Musey, 1

Natalie Banniettis, 1

Kara Bickham, 9

Andrew Tran (on behalf of study team).

1

Merck and Co., Inc., Kenilworth, NJ, USA; 2

University of Texas Medical Branch, Galveston,

TX; 3

Mahidol University, Bangkok, Thailand; 4

Wasatch Pediatrics, Murray, UT, USA; 5

Clinical

Research of Puerto Rico, Guayama, Puerto Rico; 6

Ankara University, Ankara, Turkey; 7

BenGurion University, Beer-Sheva, Israel; 8

University of Western Australia, Perth, Australia;

9

MSD UK

10.1136/archdischild-2022-rcpch.326

Aims Pneumococcal disease (PD) remains a major health concern globally. Pneumococcal conjugate vaccines (PCVs) confer

protection against PD caused by most vaccine serotypes, but

residual disease remains partly due to non-vaccine serotypes.

V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13) and serotypes 22F and 33F. This phase 3

study compared safety and immunogenicity of V114 and

PCV13 in infants.

Methods A total of 1720 healthy infants 6 to 12 weeks of

age were randomised 1:1 to receive a 4-dose regimen of

V114 or PCV13. Safety was evaluated as the proportion of

participants with adverse events (AEs). Serotype-specific immunoglobulin G (IgG) and opsonophagocytic activity (OPA)

responses were measured 1 month post-dose 3 (PD3), predose 4, and 1 month post-dose 4 (PD4).

Results The proportion, nature, maximum intensity, and duration of injection-site, systemic, and serious AEs were generally

comparable between recipients of V114 and PCV13. No serious AEs were reported to be vaccine related. In comparison

to PCV13, V114 met non-inferiority criteria for all 15 serotypes based on IgG response rates at PD3. V114 further met

non-inferiority criteria based on IgG GMCs for all serotypes

at PD3 and PD4 except serotype 6A at PD3. V114-induced

antibodies displayed functional activity as assessed by OPA.

Conclusion In healthy infants, V114 has an acceptable safety

profile and generates comparable quantitative and qualitative

immune responses to the 13 serotypes shared with PCV13,

with higher responses to serotypes unique to V114. These

results support use of V114 in infant immunisation.