Safety and Immunogenicity of V116 in Children and Adolescents With Increased Risk for Pneumococcal Disease

JRCT ID: jRCT2031230559

Registered date:11/01/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Pneumococcal infection prevention
• Date of first enrollment: 19/02/2024
• Target sample size: 35
• Countries of recruitment: United States of America,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,Finland,Japan,Poland,Japan,Turkey,Japan,France,Japan,Spain,Japan,Israel,Japan,Sweden,Japan,Thailand,Japan
• Study type: Interventional
• Intervention(s): Pneumococcal 21-valent conjugate vaccine 0.5mL in V116 group or Pneumococcal Vaccine in PPSV23 group, Polyvalent (23-valent) 0.5 mL (PPSV23) will be administered as single IM injection.

Outcome(s)

• Primary Outcome: Serotype-specific OPA responses, Solicited AEs and vaccine related SAEs
• Secondary Outcome: Serotype-specific OPA and IgG responses

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 17age old
• Gender: Both

Include criteria

1) Documented diagnosis of >= 1 of the following risk conditions for pneumococcal disease as determined by the investigator, according to local clinical standards.
2) Receiving stable medical management for the risk conditions for >=3 months with no anticipated major change in treatment expected for the duration of the study and with <=1 hospitalization directly related to the risk condition within 3 months before study vaccination.
3) At least 8 weeks prior to enrollment, completed primary PCV regimen with PCV7, PCV10, or PCV13 with either a 2+1 or 3+1 regimen according to local recommendations; all doses of the primary regimen must be of the same vaccine.
4) Is PPSV23 vaccine-naive (participant who has never received PPSV23), or PPSV23 vaccine-experienced (participant who has received not more than 1 dose of PPSV23) >=5 years before study vaccination.
5) Is an individual of any sex/gender, from >=2 years to <18 years of age, at the time of providing the informed consent/assent.

Exclude criteria

1) Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines.
2) Has a history of active hepatitis within 3 months before study vaccination (Day 1).
3) Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination (Day 1).
4) Has a history of severely decreased kidney function (outlined in the Investigator Trial File Binder for this study), dialysis, autoimmune related chronic kidney disease, nephrotic syndrome of any cause, or an acute/reversible cause of kidney disease.
5) Has a history of severe pulmonary hypertension or history of Eisenmenger syndrome.
6) Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years before study vaccination (Day 1).
7) Has a known hypersensitivity to any component of PPSV23 or V116 (including diphtheria toxoid).
8) Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented HIV infection, functional or anatomic asplenia, or autoimmune disease (including, but not limited to, the autoimmune conditions outlined in the Investigator Trial File Binder for this study).
9) Has a coagulation disorder contraindicating intramuscular vaccination.
10) Had a recent febrile illness (defined as temperature >=100.4 degrees Fahrenheit (>=38.0 degrees) or received antibiotic therapy for any illness occurring within 72 hours before receipt of study vaccine.
11) Has a known malignancy that is progressing or has required active treatment <3 years before randomization.
Note: Participants with basal cell and/or squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy, are not excluded.
12) Planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study.
13) Expected survival for <1 year according to the investigator's judgment.
14) Received >=1 dose of PCV15 or PCV20.
15) Is expected to receive any pneumococcal vaccine during the study outside of the protocol.
16) Received or is scheduled to receive systemic corticosteroids (total daily dose prednisone equivalent of >=2 mg/kg or >=20 mg/day for children >10 kg) for >=14 consecutive days and has not completed intervention >=14 days before receipt of study vaccine (Day 1) and through 30 days following vaccination.
Note: Physiologic replacement doses (prednisone equivalent of approximately 5 mg/day), topical, ophthalmic, intraarticular or soft-tissue (eg, bursa, tendon steroid injections), and inhaled/nebulized steroids are permitted.
17) Is currently receiving systemic immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
18) Received any nonlive vaccine <=14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine <=30 days after receipt of study vaccine.
Exception: inactivated influenza vaccine may be administered but must be given >=7 days before or >=15 days after receipt of study vaccine. SARS-CoV-2 mRNA or protein subunit vaccines may be administered but must be given >=14 days before or >=15 days after receipt of study vaccine. SARS-CoV-2 vaccines other than mRNA and protein subunit vaccines are not eligible for this exception and are subject to requirements of exclusion criteria 18 and 19.
19) Received any live virus vaccine (including SARS-CoV-2 live virus vaccines) <=30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine <=30 days after receipt of study vaccine.
20) Received a blood transfusion or blood products, including immunoglobulin <=6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product <=30 days after receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
21) Receiving chronic home oxygen therapy.
22) Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT06177912