Phase 3
N=1,421
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04875533 ↗Enrolled (actual)
1,421
Serious AEs
0.5%
Results posted
Nov 2023
Primary outcome: Primary: Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) — 12.4; 9.7; 6.2; 4.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 20vPnC (Biological); Saline (Other); 13vPnC (Biological); PPSV23 (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) |
12.4; 9.7; 6.2; 4.5; 4.8; 3.9 | — |
| PRIMARY Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) |
0.1; 0.6; 0.1; 0.3; 0; 0.1 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC) |
5.6; 5.9 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC) |
0.4; 0.6 | — |
| PRIMARY Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) |
207; 267; 50; 56; 813; 1029 | — |
| PRIMARY Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) |
561; 971; 1661; 777; 3331; 1933 | — |
| SECONDARY OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) |
13.1; 16.3; 4.8; 5.4; 30.1; 35.7 | — |
| SECONDARY OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) |
17.9; 30.2; 13.1; 6.1; 14.5; 7.3 | — |
| SECONDARY Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) |
72.6; 74.2; 57.6; 59.4; 80.1; 79.6 | — |
| SECONDARY Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) |
80.5; 86.3; 70.2; 56.1; 69.4; 53.1 | — |
| SECONDARY Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) |
84.3; 85.6; 82.3; 82.4; 91.7; 92.4 | — |
| SECONDARY Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) |
95.2; 96.7; 91.1; 82.1; 96.9; 92.3 | — |
| SECONDARY Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites |
1.2; 17.2; 1.2; 3.6; 0; 8.2 | — |
| SECONDARY Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites |
0.2; 1.7; 0; 1.5; 0.2; 0.2 | — |
Summary
A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age and older in Japan, Korea, and Taiwan
Eligibility Criteria
Inclusion criteria
- Male or female participants 60 years of age and older at the time of consent.
- Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention. (For adults 60 through 64 years of age to be enrolled at Japan sites: Participants must have a preexisting chronic stable disease with an elevated risk for pneumococcal disease.)
Exclusion criteria
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Serious chronic disorder, including metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Data sourced from ClinicalTrials.gov (NCT04875533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.