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Phase 3 Completed N=1,205 Randomized Double-blind Prevention

Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)

Pneumococcal Infections
Source: ClinicalTrials.gov NCT03950622 ↗
Enrolled (actual)
1,205
Serious AEs
1.8%
Results posted
Mar 2021
Primary outcomePrimary: Percentage of Participants With a Solicited Injection-site Adverse Event — 9.0; 11.3; 54.0; 42.3 Percentage of Participants — p=0.175
◆ Published Evidence
Established
91citations · ~23 / year
A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE).
Vaccine · 2022 · Open access · Likely link

Summary

The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.

Linked Publications

  • A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE).
    Vaccine · 2022 · 91 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With a Solicited Injection-site Adverse Event
9.0; 11.3; 54.0; 42.3; 12.5; 11.2 0.175
PRIMARY
Percentage of Participants With Solicited Systemic Adverse Events
5.3; 5.5; 17.4; 17.3; 11.6; 13.0 0.888
PRIMARY
Percentage of Participants With a Vaccine-related Serious Adverse Event
0.0; 0.0
PRIMARY
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
256.3; 322.6; 216.2; 135.1; 1125.6; 1661.6 <0.001 sig
PRIMARY
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes
71.4; 14.3; 56.7; 6.3 <0.001 sig
SECONDARY
GMT of Serotype-specific OPA for Serotype 3 at Day 30
216.2; 135.1 <0.001 sig
SECONDARY
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for Serotype 3 OPA Responses
70.2; 58.7 <0.001 sig
SECONDARY
Geometric Mean Concentration of Serotype-specific IgG at Day 30
5.30; 7.34; 0.96; 0.64; 1.88; 2.62
SECONDARY
Geometric Mean Fold Rise in Serotype-specific OPA
14.3; 18.7; 7.7; 5.2; 17.8; 24.4
SECONDARY
Geometric Mean Fold Rise in Serotype-specific IgG
10.6; 14.7; 6.8; 4.7; 8.0; 11.2
SECONDARY
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
75.1; 77.7; 70.2; 58.7; 79.5; 84.8
SECONDARY
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
73.1; 78.4; 61.6; 51.4; 65.0; 76.0

Eligibility Criteria

Inclusion Criteria

  • Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigator's judgment.
  • Male or female ≥50 years of age at the time of signing the informed consent. (For Japan only: Is male or female ≥65 years of age at the time of signing the informed consent)
  • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention.
  • Provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.

Exclusion Criteria

  • History of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1).
  • Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine.
  • Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
  • Coagulation disorder contraindicating intramuscular (IM) vaccinations.
  • Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine.
  • History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1).
  • Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
  • Has 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.
  • Has 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.)
  • Is receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
  • Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.)
  • Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine.
  • Has received a blood transfusion or blood products, including immunoglobulin, 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03950622) 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.

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