A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED)

Lupinacci, Robert; Rupp, Richard; Wittawatmongkol, Orasri; Jones, Jake D.; Quinones, Jeffrey; Ulukol, Betül; Dagan, Ron; Richmond, Peter; Stek, Jon E.; Romero, Lizbeth; Koseoglu, Sandra; Tamms, Gretchen; McFetridge, Richard; Li, Jianing; Cheon, Kyeongmi; Musey, Luwy; Banniettis, Natalie; Bickham, Kara

doi:10.1016/j.vaccine.2022.12.054

Cited by 19 publications

(15 citation statements)

References 37 publications

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“…These results are consistent with the findings from a global study in addition to a local Japanese study in healthy infants. 21 In addition, co-administration of V114-SC and V114-IM with DTaP–IPV was comparable with the co-administration of PCV13-SC with DTaP–IPV in terms of the safety profile and immune responses to each of the antigens in DTaP–IPV. These results provide further evidence to support the introduction of V114 with both SC and IM routes into Japanese routine immunization schedules.…”

Section: Discussionmentioning

confidence: 86%

“…These results observed in both vaccines with SC administration are consistent with another Japanese study that assessed V114 in healthy infants. 21 The differences observed in injection-site AEs between IM and SC routes have been commonly observed with the administration of other pediatric vaccines. 25 , 26 Historically, in Japan, SC administration has been the preferred route for vaccines, due to reports of serious muscle contracture following IM administration.…”

Section: Discussionmentioning

confidence: 97%

“…Subcutaneous (SC) injection is the typical administration route used for most pediatric vaccines in Japan. 21 , 23 Using this administration route, a Phase III study in Japanese infants demonstrated that V114 is well tolerated and immunogenic, with non-inferior responses to the 13 serotypes shared with PCV13 and higher responses to the two additional serotypes included in V114. 24 However, intramuscular (IM) administration may be beneficial as an alternative route in infants, as it is known to be associated with a lower frequency of injection-site adverse events (AEs) compared with SC administration, while having comparable immunogenicity to the SC route.…”

Section: Introductionmentioning

confidence: 99%

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Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028)

Ishihara

Kuroki²,

Hidaka³

et al. 2023

Human Vaccines & Immunotherapeutics

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This Phase I study evaluated the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), via subcutaneous (SC) or intramuscular (IM) administration, in healthy Japanese infants 3 months of age. A total of 133 participants were randomized to receive four doses (3 + 1 regimen) of V114-SC ( n = 44), V114-IM ( n = 45), or 13-valent PCV (PCV13)-SC ( n = 44) at 3, 4, 5, and 12–15 months of age. Diphtheria, tetanus, and pertussis–inactivated poliovirus (DTaP–IPV) vaccine was administered concomitantly at all vaccination visits. The primary objective was to assess the safety and tolerability of V114-SC and V114-IM. Secondary objectives were to assess the immunogenicity of PCV and DTaP–IPV at 1-month post-dose 3 (PD3). On days 1–14 following each vaccination, the proportions of participants with systemic adverse events (AEs) were comparable across interventions, whereas injection-site AEs were higher with V114-SC (100.0%) and PCV13-SC (100.0%) than with V114-IM (88.9%). Most AEs were mild or moderate in severity and no vaccine-related serious AEs or deaths were reported. Serotype-specific immunoglobulin G (IgG) response rates at 1-month PD3 were comparable across groups for most shared serotypes between V114 and PCV13. For additional V114 serotypes 22F and 33F, IgG response rates were higher with V114-SC and V114-IM than with PCV13-SC. DTaP–IPV antibody response rates at 1-month PD3 for V114-SC and V114-IM were comparable with PCV13-SC. Findings suggest that vaccination with V114-SC or V114-IM in healthy Japanese infants is generally well tolerated and immunogenic.

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Section: Discussionmentioning

confidence: 86%

Section: Discussionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

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Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028)

Ishihara

Kuroki²,

Hidaka³

et al. 2023

Human Vaccines & Immunotherapeutics

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“…The safety findings of this pooled analysis in preterm infants are consistent with those reported in infants receiving V114. 48,49,61,62 V114 was immunogenic for all 15 serotypes included in the vaccine among healthy preterm infants. A large proportion of responders achieved the IgG threshold concentration of ≥0.35 μg/mL after the 3-dose primary infant series and after the toddler dose.…”

Section: Discussionmentioning

confidence: 99%

“…This study was a descriptive pooled subgroup analysis of data from 4 pediatric phase 3, double-blind, randomized, activecomparator-controlled, multicenter studies to evaluate the safety, tolerability and immunogenicity of V114 in healthy preterm infants. [48][49][50][51] The 4 studies included in this analysis were selected based on similarities with respect to study design, PCV dosing regimen and participant population (Table, Supplemental Digital Content 1, http://links.lww.com/INF/F208).…”

Section: Methodsmentioning

confidence: 99%

Safety and Immunogenicity of V114 in Preterm Infants: A Pooled Analysis of Four Phase Three Studies

Chapman,

Patel,

Flores

et al. 2023

Pediatric Infectious Disease Journal

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Background: Risk of invasive pneumococcal disease is 3-fold higher in preterm versus full-term infants. V114 is a 15-valent pneumococcal conjugate vaccine (PCV) containing the 13 serotypes in PCV13 plus 2 unique serotypes, 22F and 33F. A pooled subgroup analysis was performed in preterm infants (<37 weeks gestational age) enrolled in 4 pediatric phase 3 studies evaluating the safety and immunogenicity of different 4-dose regimens of V114 or PCV13. Methods: Healthy preterm infants were randomized 1:1 to receive V114/PCV13 in the 4 studies. Safety was evaluated as the proportion of participants with adverse events (AEs) following receipt of PCV. Serotype-specific antipneumococcal immunoglobulin G (IgG) geometric mean concentrations, IgG response rates and opsonophagocytic activity geometric mean titers were measured at 30 days postdose 3, pretoddler dose and 30 days postdose 4. Results: V114 and PCV13 were administered to 174 and 180 participants, respectively. Mean gestational age was 35.4 weeks (range: 27≤37 weeks). Proportions of participants with AEs were comparable between vaccination groups; most AEs experienced were of short duration (≤3 days) and mild-to-moderate intensity. V114-elicited IgG geometric mean concentrations, IgG response rates and opsonophagocytic activity geometric mean titers were generally comparable to PCV13 for the 13 shared serotypes and higher for serotypes 22F and 33F at 30 days postdose 3 and postdose 4. Conclusions: In preterm infants, V114 was well tolerated and induced comparable immune responses to PCV13 for the 13 shared serotypes and higher immune responses to serotypes 22F and 33F. Results support the use of V114 in preterm infants.

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Pneumokokkenimpfung im Säuglings- und im Kleinkindalter

Vygen-Bonnet,

Schlaberg,

Kremer-Flach

et al. 2024

Monatsschr Kinderheilkd

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A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED)

Cited by 19 publications

References 37 publications

Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028)

Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028)

Safety and Immunogenicity of V114 in Preterm Infants: A Pooled Analysis of Four Phase Three Studies

Pneumokokkenimpfung im Säuglings- und im Kleinkindalter

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