Phase 2
Completed N=253
Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT02573181 ↗
Enrolled (actual)
253
Serious AEs
0.8%
Results posted
Aug 2019
Primary outcomePrimary: Percentage of Participants With an Adverse Event (AE) — 68.5; 64.3 Percentage of Participants
Summary
This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE) |
68.5; 64.3 | — |
| PRIMARY Percentage of Participants With a Solicited Injection-site Adverse Event (AE) |
7.9; 7.1; 14.2; 6.3; 55.1; 44.4 | — |
| PRIMARY Percentage of Participants With a Solicited Systemic Adverse Event (AE) |
18.1; 19.0; 5.5; 8.7; 15.7; 11.1 | — |
| PRIMARY Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) |
1.11; 1.27; 3.31; 3.42; 0.19; 0.19 | — |
| PRIMARY Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) |
2.98; 2.70; 3.14; 2.03; 3.37; 3.28 | — |
| PRIMARY Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) |
32.8; 26.5; 36.1; 17.1; 36.1; 35.9 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) |
20.30; 24.24; 109.25; 91.53; 23.37; 26.71 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) |
4.16; 3.33; 5.06; 3.24; 6.59; 7.94 | — |
| SECONDARY Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) |
40.7; 33.6; 53.8; 39.3; 44.1; 54.9 | — |
Eligibility Criteria
Inclusion Criteria
- Is in good health (any underlying chronic illness must be documented to be in stable condition)
- Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry
- Is a male or postmenopausal female
Exclusion Criteria
- Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine
- Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
- Is known or suspected impairment of immune function
- Has received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination
- Has a coagulation disorder contraindicating intramuscular vaccination
- Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease
- Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion
- Has participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study
- Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
Data sourced from ClinicalTrials.gov (NCT02573181). 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.