A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
ConditionPneumococcal Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-15
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
Is 12 through 15 months of age
Was born at full term (gestational age greater than or equal to 37 weeks)
Disqualifiers
Has received prior administration of any pneumococcal vaccine
Has a history of invasive pneumococcal disease (IPD)
Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid
Trial design
Design model
Parallel
Treatments tested in this trial
V118C (Stage 1)
Biological/VaccineIM administration of V118C
V118C (Stage 2)
Biological/VaccineIM administration of V118C
PCV20 (Stage 1)
Biological/VaccineIM administration of PCV20
PCV20 (Stage 2)
Biological/VaccineIM administration of PCV20
Treatment groups
210 Participants
are divided into 4 treatment groupsGroup A: V118C (Stage 1)Experimental treatment 1 intervention
Group B: V118C (Stage 2)Experimental treatment 1 intervention
Group C: PCV20 (Stage 1)Active comparator 1 intervention
Group D: PCV20 (Stage 2)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
Time frame
Up to approximately 30 minutes postvaccination2
Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
Time frame
Up to approximately 7 days postvaccination3
Stage 1: Percentage of Participants With Solicited Systemic AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported.
Time frame
Up to approximately 7 days postvaccination4
Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
Time frame
Up to approximately 28 days postvaccinationSecondary outcomes
1
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of Serotype-specific IgG at 30 days postvaccination with V118C and PCV20 will be reported.
Time frame
Up to approximately 30 days post vaccination2
Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of GMCs of serotype-specific IgG of V118C to PCV20 will be reported.
Time frame
Approximately Day 30 postvaccination3
Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)
Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. GMFRs of serotype-specific IgG from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported.
Time frame
Day 1 (Baseline) and approximately Day 30 postvaccination4
Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported.
Time frame
Day 1 (Baseline) and approximately Day 30 postvaccinationSponsors and contacts
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Source ClinicalTrials.gov