Phase 2
Completed N=690
Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT02547649 ↗
Enrolled (actual)
690
Serious AEs
0.4%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants With an Adverse Event (AE) — 74.9; 72.3; 67.4 Percentage of Participants
Summary
The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants
≥50 years of age in good health.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE) |
74.9; 72.3; 67.4 | — |
| PRIMARY Percentage of Participants With a Solicited Injection-site Adverse Event (AE) |
8.7; 11.3; 10.1; 62.3; 60.2; 52.4 | — |
| PRIMARY Percentage of Participants With a Solicited Systemic Adverse Event (AE) |
9.5; 7.4; 6.2; 22.9; 18.6; 14.1 | — |
| PRIMARY Percentage of Participants With a Serious Adverse Event (SAE) |
0.4; 0.9; 0.0 | — |
| PRIMARY Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE) |
0.0; 0.0; 0.0 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination |
196.79; 144.01; 127.19; 104.78; 61.41; 33.10 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination |
5.04; 4.00; 4.15; 0.94; 0.61; 0.48 | — |
| SECONDARY Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs) |
70.9; 66.3; 61.7; 71.8; 64.2; 44.1 | — |
| SECONDARY Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies |
78.2; 69.8; 65.4; 58.3; 46.5; 31.3 | — |
Eligibility Criteria
Inclusion Criteria
- Good health; any underlying chronic illness must be documented to be in stable condition
- Highly unlikely to conceive through 6 weeks after administration of the study vaccine
Exclusion Criteria
- Prior administration of any pneumococcal vaccine
- History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease
- Known hypersensitivity to any vaccine component
- Known or suspected impairment of immune function
- 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
- 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
- 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.
- 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
- Breast feeding
- 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 (NCT02547649). 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.