VAXNEUVANCE uses
VAXNEUVANCE®▼ (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) has been studied across several adult populations1–5
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
VAXNEUVANCE®▼ (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.1
VAXNEUVANCE®▼ (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.1
VAXNEUVANCE has been studied:
In healthy, pneumococcal-vaccine naïve adults ≥50 years2
Study design
PNEU-AGE was a Phase 3, multicentre, randomised, double-blind, active comparator-controlled study conducted from June 2019 through to March 2020 at 30 sites.
| N=1,202 adult patients | Stratification | Randomised 1:1 | Primary endpoints |
|---|---|---|---|
| Inclusion criteria: ● Male or female participants in generally good health and/or with stable underlying medical conditions ≥50 years of age (or for sites in Japan, ≥65 years of age) | Participant age at enrollment 50–64 years 65–74 years ≥75 years | V114 (VAXNEUVANCE) single dose (n=602) | Proportion of participants with: ● Solicited injection-site AEs from pre-vaccination (Day 1) through Day 5 post-vaccination ● Solicited systemic AEs from Day 1 through Day 14 post-vaccination ● The broad AE categories of any AE, any SAE or any vaccine-related SAE Non-inferiority of immune responses for shared PCV13 STs and superiority of immune response for STs unique to V114 |
| Key exclusion criteria: ● History of IPD or other culture positive pneumococcal disease within the previous 3 years ● Known hypersensitivity to a vaccine component ● Known or suspected impairment of immunological function ● Prior receipt of any pneumococcal vaccine | Participant age at enrollment 50–64 years 65–74 years ≥75 years | PCV13 single dose (n=600) | Secondary endpoints ● Superiority of immune response for ST 3 via the OPA GMTs at 30 days post-vaccination ● Proportions of participants with a ≥4-fold rise from Day 1 to 30 days post-vaccination (Day 30) ● ST-specific specific IgG GMCs at 30 days following vaccination with V114 compared to PCV13 ● Observed ST-specific OPA GMTs and IgG GMCs at 30 days post-vaccination ● GMFR and proportions of participants with a ≥4-fold rise from Day 1 to 30 days post-vaccination (Day 30) for both OPA and IgG responses |
Table adapted from Platt HL, et al. Vaccine 2022.
As part of a sequential regimen in healthy, pneumococcal-vaccine naïve adults aged ≥50 years3
Study design
Phase 3 multicentre, randomised, double-blind, active comparator-controlled study conducted from June 2018 through to December 2019.
| N=674 adult patients | Stratification | Randomised 1:1 | Primary endpoints |
|---|---|---|---|
| Inclusion criteria: ● Male or female participants in generally good health and/or with stable underlying medical conditions >50 years of age | Participant age at enrollment 50–64 years 65–74 years ≥75 years | V114 (VAXNEUVANCE) single dose (n=327) | Proportion of participants with: ● With solicited injection-site AEs from Day 1 through to Day 5 post-vaccination ● With solicited systemic AEs from Day 1 through to Day 14 post-vaccination ● Within the broad AE categories of any AE or SAE, including vaccine-related SAEs Evaluate the serotype-specific OPA GMTs for the 15 serotypes included in V114 at 30 days post-vaccination with PPV23 (Month 13) for participants administered V114 compared with participants administered PCV13 |
| Key exclusion criteria: ● History of IPD or other culture positive pneumococcal disease within the previous 3 years ● Known hypersensitivity to a vaccine component ● Known or suspected impairment of immunological function ● Prior receipt of any pneumococcal vaccine | Participant age at enrollment 50–64 years 65–74 years ≥75 years | PCV13 (13-valent pneumococcal conjugate vaccine) single dose (n=325) | Secondary endpoints Key secondary immunogenicity endpoints included serotype-specific: ● IgG GMCs for the 15 serotypes included in V114 at 30 days post-vaccination with PPV23 (Month 13) ● OPA GMTs and IgG GMCs at 30 days post-vaccination with V114 or PCV13 (Day 30), ● OPA GMTs and IgG GMCs at 12 months post-vaccination with V114 or PCV13 (Month 12) |
Table adapted from Song J-Y, et al. Vaccine 2021.
In adults ≥65 years previously vaccinated with PPV234
Study design
Phase 2 multicentre, double-blind, active-comparator study conducted from October 2015 through to January 2016.
| N=253 adult patients | Stratification | Randomised 1:1 | Primary endpoints |
|---|---|---|---|
| Inclusion criteria: ● Male or female participants in generally good health and/or with stable underlying medical conditions ≥65 years of age with prior history of PPV23 vaccination (≥1 year ago) | Participant age at enrolment 65 to 74 years of age, 1 to 3 years after PPV23 65 to 74 years of age, greater than 3 years after PPV23 75 years of age or older, 1 to 3 years after PPV23 75 years of age or older, greater than 3 years after PPV23 | V114 (VAXNEUVANCE) single dose (n=127) | Proportions of participants: ● An AE up to Day 44 post-vaccination ● Solicited injection-site AEs from Day 1 through to Day 5 post-vaccination ● Solicited systemic AE from Day 1 through to Day 14 post-vaccination ● Serotype-specific IgG GMCs at Day 30 post-vaccination ● GMFR from baseline of serotype-specific IgG at Day 30 post-vaccination ● ≥4-fold rise from baseline in serotype-specific IgG GMCs at Day 30 post-vaccination |
| Participant age at enrolment 65 to 74 years of age, 1 to 3 years after PPV23 65 to 74 years of age, greater than 3 years after PPV23 75 years of age or older, 1 to 3 years after PPV23 75 years of age or older, greater than 3 years after PPV23 | PCV13 (13-valent pneumococcal conjugate vaccine) single dose (n=126) | Secondary endpoints ● Serotype-specific OPA GMTs at Day 30 post-vaccination ● GMFR from baseline of serotype-specific OPA at Day 30 post-vaccination ● ≥4-fold rise from baseline in serotype-specific OPA GMTs at Day 30 post-vaccination |
Table adapted from Peterson JT, et al. Human Vaccines & Immunotherapeutics 2019.
Concomitantly with inactivated influenza vaccine5
Study design
PNEU-FLU was a Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group study conducted from September 2018 through to June 2019.
| N=1,200 adult patients | Stratification | Randomised 1:1 | Primary endpoints |
|---|---|---|---|
| Inclusion criteria: ● Male or female participants ≥50 years of age in generally good health and/or with stable underlying medical conditions | Participant age at enrollment 50–64 years 65–74 years ≥75 years At least 50% of participants ≥65 years By history of PPV23 receipt versus non-receipt At least 50% of participants PPV23-naïve | Concomitant V114 (VAXNEUVANCE) single dose and QIV (quadrivalent influenza vaccine) (n=600) | Percentage of participants with: ● Solicited injection-site AEs from Day 1 through to Day 5 post-vaccination ● Solicited systemic AE from Day 1 through to Day 14 post-vaccination ● Within the broad AE categories of any AE or SAE including vaccine-related SAEs ● Non-inferiority of serotype-specific OPA GMTs at 30 days post-vaccination with V114 for all 15 serotypes included in V114 ● Non-inferiority of strain-specific HAI GMTs at 30 days post-vaccination with QIV for all four influenza strains included in QIV |
| Key exclusion criteria: ● History of IPD or other culture positive pneumococcal disease within the previous 3 years ● Known hypersensitivity to a vaccine component ● Known or suspected impairment of immunological function ● Prior receipt of any pneumococcal vaccine ● Prior administration of influenza vaccine during the 2018/2019 influenza season | Participant age at enrollment 50–64 years 65–74 years ≥75 years At least 50% of participants ≥65 years By history of PPV23 receipt versus non-receipt At least 50% of participants PPV23-naïve | Non-concomitant V114 and QIV (n=600) | Secondary endpoints For V114: ● Serotype-specific IgG GMCs at 30 days post-vaccination with V114 ● IgG GMCs and IgG GMC ratios (with corresponding 95% CIs) at 30 days post-vaccination ● Observed serotype-specific GMFRs and the proportions of participants with a ≥4-fold rise from pre-vaccination to 30 days post-vaccination with V114 for both OPA and IgG responses For influenza: ● Strain-specific GMFRs from pre-vaccination to 30 days post-vaccination with QIV ● Proportions of participants with an HAI titre of ≥1:40 at 30 days post-vaccination with QIV ● Proportions of participants who seroconverted at 30 days post-vaccination with QIV |
Table adapted from Severance R, et al. Human Vaccines & Immunotherapeutics 2021.
AE = Adverse Event; GMC = Geometric Mean Concentration; GMFR = Geometric Mean Fold Rise; GMT = Geometric Mean Titre; HAI= Haemagglutination Inhibition; IgG = Immunoglobulin G; IPD = Invasive Pneumococcal Disease; OPA = Opsonophagocytic Activity; PCV13 = 13-Valent Pneumococcal Conjugate Vaccine; PPV23, 23-Valent Pneumococcal Polysaccharide Vaccine; SAE = Serious Adverse Event; QIV = Quadrivalent Influenza Vaccine; V114 = VAXNEUVANCE 15-Valent Pneumococcal Conjugate Vaccine.
PPV23: 23-valent pneumococcal polysaccharide vaccine is recommended for active immunisation against pneumococcal disease in children aged from 2 years, adolescents and adults.
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References
- VAXNEUVANCE Summary of Product Characteristics.
- Platt HL, et al. A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults ≥50 years of age and older (PNEU-AGE). Vaccine. 2022;40:162–172.
- Song J-Y, et al. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged ≥50 years: A randomized phase III trial (PNEU-PATH). Vaccine. 2021;39:6422–6436.
- Peterson JT, et al. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Human Vaccines & Immunotherapeutics. 2019;15(3):540–54.
- Severance R, et al. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, administered concomitantly with influenza vaccine in healthy adults aged ≥50 years: a randomized phase 3 trial (PNEU-FLU). Human Vaccines & Immunotherapeutics. 2021. Available at: https://doi.org/10.1080/21645515.2021.1976581.
Supporting documentation
VAXNEUVANCE®▼ (pneumococcal 15-valent conjugate vaccine [CRM197 protein], absorbed)
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
PNEUMOVAX® 23 (pneumococcal polysaccharide vaccine)
Prescribing Information
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