Phase 3
Completed N=900
A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT03620162 ↗
Enrolled (actual)
900
Serious AEs
11.1%
Results posted
Aug 2021
Primary outcomePrimary: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) — 47.5; 37.6; 38.8; 43.0 Percentage of Participants — p== 0.525
◆ Published Evidence
Emerging
18citations · ~6 / year
A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION).
Summary
The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.
Linked Publications
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A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Solicited Injection-site Adverse Event (AE) |
47.5; 37.6; 38.8; 43.0; 44.1; 34.6 | = 0.525 |
| PRIMARY Percentage of Participants With a Solicited Systemic AE |
35.8; 32.0; 27.0; 35.2; 34.6; 67.6 | = 0.825 |
| PRIMARY Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) |
0; 0; 0.6; 0; 0 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 |
2.02; 1.69; 1.89; 1.68; 1.46; 0.72 | — |
| SECONDARY Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3 |
98.6; 99.3; 98.7; 98.9 | < 0.001 sig |
| SECONDARY Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3 |
286.5; 329.5; 298.3; 307.0 | < 0.001 sig |
| SECONDARY GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 |
1.93; 1.99; 1.86; 1.35; 1.27; 0.54 | — |
| SECONDARY Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 |
97.9; 100; 99.2; 97.8; 96.6; 73.2 | — |
| SECONDARY Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 |
2.02; 1.46; 0.72; 0.89; 1.51; 1.35 | — |
Eligibility Criteria
Inclusion Criteria
- Is Healthy, based on clinical judgment of the investigator
- Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
Exclusion Criteria
- Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine
- Has any contraindication to the concomitant study vaccines being administered in the study
- Has a known or suspected impairment of immunological function
- Has a history of congenital or acquired immunodeficiency
- Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
- Has or his/her mother has a documented hepatitis B surface antigen - positive test
- Has known or history of functional or anatomic asplenia
- Has failure to thrive based on the clinical judgment of the investigator
- Has a known coagulation disorder contraindicating intramuscular vaccination
- Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
- Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
- Has received a dose of any pneumococcal vaccine prior to study entry
- Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
- Has received a dose of rotavirus vaccine prior to study entry
- Has received a blood transfusion or blood products, including immunoglobulins
- Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study
- Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
- Has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
Data sourced from ClinicalTrials.gov (NCT03620162) 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.