Phase 3
Completed N=652
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT03480763 ↗
Enrolled (actual)
652
Serious AEs
3.1%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ — 9.8; 5.6; 55.0; 41.4 Percentage of Participants — p=0.043
Summary
This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ |
9.8; 5.6; 55.0; 41.4; 16.2; 11.4 | 0.043 sig |
| PRIMARY Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 |
17.4; 16.9; 62.1; 58.6; 28.2; 26.2 | 0.855 |
| PRIMARY Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ |
6.4; 5.2; 23.5; 13.9; 14.1; 12.7 | 0.523 |
| PRIMARY Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 |
8.4; 8.3; 25.8; 21.9; 12.1; 12.6 | 0.961 |
| PRIMARY Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™ |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23 |
0.0; 0.0 | — |
| PRIMARY Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 |
392.2; 283.2; 282.6; 262.8; 1671.9; 1580.4 | — |
| SECONDARY Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 |
5.21; 5.68; 1.05; 1.05; 1.99; 2.29 | — |
| SECONDARY GMT of Serotype-specific OPA at Day 30 |
361.6; 296.2; 245.4; 129.4; 1280.4; 1685.9 | — |
| SECONDARY GMC of Serotype-specific IgG at Day 30 |
6.97; 7.86; 1.02; 0.59; 2.36; 2.98 | — |
| SECONDARY Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 |
22.3; 16.7; 8.0; 4.4; 18.3; 23.3 | — |
| SECONDARY GMFR in Serotype-specific IgG Day 1 to Day 30 |
13.0; 14.4; 6.7; 3.9; 10.1; 12.4 | — |
| SECONDARY Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 |
83.4; 76.1; 72.1; 51.1; 79.3; 84.6 | — |
| SECONDARY Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 |
74.9; 80.8; 62.4; 42.8; 71.4; 74.2 | — |
| SECONDARY GMT of Serotype-specific OPA at Month 12 |
138.2; 116.2; 88.3; 56.3; 477.2; 666.5 | — |
| SECONDARY GMC of Serotype-specific IgG at Month 12 |
2.73; 3.52; 0.39; 0.28; 1.00; 1.31 | — |
| SECONDARY GMFR in Serotype-specific OPA Day 1 to Month 12 |
9.2; 7.3; 3.0; 2.1; 7.0; 9.4 | — |
| SECONDARY GMFR in Serotype-specific IgG Day 1 to Month 12 |
5.2; 6.6; 2.6; 1.8; 4.3; 5.5 | — |
| SECONDARY Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 |
69.4; 61.4; 39.4; 25.7; 63.0; 67.1 | — |
| SECONDARY Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 |
56.0; 65.6; 27.0; 12.4; 47.2; 57.7 | — |
| SECONDARY GMFR in Serotype-specific OPA Day 1 to Month 13 |
24.7; 15.5; 9.1; 8.7; 23.8; 21.5 | — |
| SECONDARY GMFR in Serotype-specific IgG Day 1 to Month 13 |
9.9; 10.5; 6.9; 6.7; 8.6; 9.5 | — |
| SECONDARY Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 |
87.9; 78.8; 78.7; 76.0; 83.7; 84.3 | — |
| SECONDARY Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 |
79.5; 78.5; 72.5; 68.6; 76.6; 75.5 | — |
| SECONDARY GMFR in Serotype-specific OPA Month 12 to Month 13 |
2.7; 2.3; 3.0; 4.1; 3.3; 2.3 | — |
| SECONDARY GMFR in Serotype-specific IgG Month 12 to Month 13 |
1.9; 1.6; 2.6; 3.7; 2.0; 1.7 | — |
| SECONDARY Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 |
29.7; 25.6; 39.0; 49.6; 36.3; 22.3 | — |
| SECONDARY Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 |
15.0; 8.8; 31.4; 43.8; 14.2; 8.8 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female in good health
- Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last study vaccine.
Exclusion Criteria
- History of invasive pneumococcal disease
- Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine.
- Known or suspected impairment of immune function
- Coagulation disorder contraindicating intramuscular vaccination
- History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Female participant: positive urine or serum pregnancy test
- Prior administration of any pneumococcal vaccine
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
- Received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon steroid injections], and inhaled/nebulized steroids are permitted).
- Received immunosuppressive therapy
- Received a blood transfusion or blood products within 6 months of enrollment
- Participated in another clinical study of an investigational product within 2 months of enrollment
- Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence.
Data sourced from ClinicalTrials.gov (NCT03480763). 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.