Phase 3
Completed N=1,184
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT04031846 ↗
Enrolled (actual)
1,184
Serious AEs
10.8%
Results posted
May 2023
Primary outcomePrimary: Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) — 45.3; 44.7; 41.9; 39.1 Percentage of Participants — p== 0.824
◆ Published Evidence
Established
26citations · ~9 / year
A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1).
Summary
This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.
Linked Publications
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A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) |
45.3; 44.7; 41.9; 39.1; 40.5; 29.3 | = 0.824 |
| PRIMARY Percentage of Participants That Report at Least 1 Solicited Systemic AE |
33.9; 33.5; 71.7; 66.3; 46.2; 41.8 | = 0.885 |
| PRIMARY Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE) |
0.0; 0.2 | — |
| PRIMARY Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) |
1.29; 2.08; 0.84; 0.66; 1.29; 1.73 | < 0.001 sig |
| PRIMARY Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD |
96.7; 99.4; 92.0; 83.8; 95.7; 97.9 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD |
99.3; 99.8; 99.6; 100.0; 99.4; 99.6 | < 0.001 sig |
| SECONDARY Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™ |
45.39; 47.07 | < 0.001 sig |
| SECONDARY Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS |
1.30; 1.62; 0.88; 0.48; 1.41; 1.30 | — |
| SECONDARY Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS |
95.4; 97.4; 93.5; 67.8; 93.9; 96.8 | — |
| SECONDARY Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD |
136.8; 164.6; 321.5; 303.0; 2231.7; 3206.4 | — |
| SECONDARY Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD |
95.0; 98.1; 100.0; 98.1; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD |
99.6; 99.1; 83.8 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy
- 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
- 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
- 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 judgement of the Investigator
- Has a bleeding 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 any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenzae type b conjugate vaccine, poliovirus vaccine, rotavirus vaccine, or any other combination thereof, 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. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor
- Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study
Data sourced from ClinicalTrials.gov (NCT04031846) 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.