Phase 3
Completed N=2,409
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT03692871 ↗
Enrolled (actual)
2,409
Serious AEs
9.9%
Results posted
May 2022
Primary outcomePrimary: Percentage of Participants With a Solicited Injection-site Adverse Event — 43.9; 36.0; 25.3; 25.6 Percentage of participants — p== 0.003
◆ Published Evidence
Emerging
10citations · ~3 / year
Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study.
Summary
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.
Linked Publications
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Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Solicited Injection-site Adverse Event |
43.9; 36.0; 25.3; 25.6; 42.9; 36.5 | = 0.003 sig |
| PRIMARY Percentage of Participants With a Solicited Systemic Adverse Event |
41.6; 36.0; 74.9; 69.3; 55.4; 55.0 | = 0.033 sig |
| PRIMARY Percentage of Participants With a Vaccine-related Serious Adverse Event |
0.1; 0 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) |
1.15; 1.61; 0.86; 0.58; 1.41; 1.27 | — |
| SECONDARY GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) |
0.30; 0.47; 0.22; 0.13; 0.24; 0.31 | — |
| SECONDARY GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) |
1.56; 1.96; 1.04; 0.79; 1.55; 1.61 | — |
| SECONDARY Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) |
97.4; 97.1; 89.5; 74.3; 94.7; 97.1 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
- Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
- Have 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
- Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
- Known or suspected impairment of immunological function
- History of congenital or acquired immunodeficiency
- Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
- Known or history of functional or anatomic asplenia
- Failure to thrive based on the clinical judgment of the investigator
- Known coagulation disorder contraindicating intramuscular vaccination
- 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)
- Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
- Received a dose of any pneumococcal vaccine prior to study entry
- Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
- 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.
- 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 who is investigational site or Sponsor staff directly involved with this study.
Data sourced from ClinicalTrials.gov (NCT03692871) 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.