Phase 3
Completed N=1,710
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Source: ClinicalTrials.gov NCT03828617 ↗Enrolled (actual)
1,710
Serious AEs
0.6%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants With Local Reactions Within 10 Days After Vaccination — 7.0; 6.2; 3.9; 3.3 percentage of participants
◆ Published Evidence
Established
77citations · ~15 / year
A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age.
Summary
This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
Linked Publications (2)
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A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age.
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Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 10 Days After Vaccination |
7.0; 6.2; 3.9; 3.3; 2.6; 2.9 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination |
1.2; 0.8; 0.8; 0.4; 0.3; 0.4 | — |
| PRIMARY Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination |
6.8; 5.3 | — |
| PRIMARY Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination |
0.7; 0 | — |
| PRIMARY Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination |
1.0; 2.0 | — |
| PRIMARY Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination |
199.5; 175.1; 164.6; 47.3; 46.8; 43.1 | — |
| SECONDARY Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination |
20.2; 17.8; 17.3; 5.0; 5.0; 4.6 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination |
83.7; 82.9; 82.4; 56.1; 57.8; 53.0 | — |
| SECONDARY Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination |
91.8; 92.8; 91.0; 89.7; 89.6; 88.9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults ≥18 and <50 years of age.
- 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 investigational product.
- Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.
Exclusion Criteria
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Pregnant female subjects or breastfeeding female subjects (known or suspected).
Data sourced from ClinicalTrials.gov (NCT03828617) and the linked publication. 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. Informational only — not medical advice.