A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: V118C (Stage 1), V118C (Stage 2), PCV20 (Stage 1), PCV20 (Stage 2).
- Who it may be relevant to
- Registry conditions: Pneumococcal Infection. Basic parameters: 2 months — 15 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children
Overview
Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria. This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.
Detailed description
Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).
Interventions
- Biological V118C (Stage 1)
IM administration of V118C - Biological V118C (Stage 2)
IM administration of V118C - Biological PCV20 (Stage 1)
IM administration of PCV20 - Biological PCV20 (Stage 2)
IM administration of PCV20
Primary outcome measures
- Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination [Time frame: Up to approximately 30 minutes postvaccination]
- Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) [Time frame: Up to approximately 7 days postvaccination]
- Stage 1: Percentage of Participants With Solicited Systemic AEs [Time frame: Up to approximately 7 days postvaccination]
- Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs [Time frame: Up to approximately 28 days postvaccination]
- Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) [Time frame: Up to approximately 12 months postvaccination]
- Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs) [Time frame: Up to approximately 12 months postvaccination]
- Stage 2: Percentage of Participants With Immediate AEs Following Vaccination [Time frame: Up to approximately 30 minutes after each vaccination]
- Stage 2: Percentage of Participants With Solicited Injection-Site AEs [Time frame: Up to approximately 7 days after each vaccination]
- Stage 2: Percentage of Participants With Solicited Systemic AEs [Time frame: Up to approximately 7 days after each vaccination]
- Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs [Time frame: Up to approximately 28 days after each vaccination]
Secondary outcome measures (12)
- Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG) [Time frame: Up to approximately 30 days post vaccination]
- Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20] [Time frame: Approximately Day 30 postvaccination]
- Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG) [Time frame: Day 1 (Baseline) and approximately Day 30 postvaccination]
- Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations [Time frame: Day 1 (Baseline) and approximately Day 30 postvaccination]
- Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 3 [Time frame: Up to approximately 30 days postdose 3]
- Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Predose 4 [Time frame: Up to approximately 6 months post dose 3]
- Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 4 [Time frame: Up to approximately 30 days postdose 4]
- Stage 2: Difference in the Response Rates [V118C minus PCV20] for Each Serotype at 30 Days Postdose 3 [Time frame: Up to approximately 30 days postdose 3]
- Stage 2: Difference in the Response Rates [V118C Minus PCV20] for Each Serotype at 30 Days Postdose 4 [Time frame: Up to approximately 30 days postdose 4]
- Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 3 [Time frame: Up to approximately 30 days postdose 3]
- Stage 2: GMCs of Serotype-Specific IgG at 30 Days Predose 4 [Time frame: Up to approximately 6 months post dose 3]
- Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 4 [Time frame: Up to approximately 30 days postdose 4]
Eligibility criteria
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
Stage 1:
- Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
- Is 12 through 15 months of age
Stage 2:
\- Is approximately 2 months of age
Both Stages:
- Was born at full term (gestational age greater than or equal to 37 weeks)
Exclusion criteria
The main exclusion criteria include but are not limited to the following:
Stage 1:
\- Has received a PCV dose at 10 months of age and older
Stage 2:
- Has received prior administration of any pneumococcal vaccine
Both stages:
- Has a history of invasive pneumococcal disease (IPD)
- Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 14 centers
- Madera Family Medical Group ( Site 1004) — Madera
- Acevedo Clinical Research Associates ( Site 1029) — Miami
- University of South Florida-Department of Pediatrics ( Site 1002) — Tampa
- Cotton O'Neil Research Center ( Site 1039) — Topeka
- University of Louisville, Norton Children's Research Institute ( Site 1005) — Louisville
- The Pediatric Center ( Site 1025) — Columbia
- Saint Louis University Center for Vaccine Development ( Site 1031) — St Louis
- Child Health Care Associates ( Site 1035) — East Syracuse
- … and 6 more centers
Identifiers
NCT: NCT07300267 · V118C-002