NCT06675032

Phase I Clinical Trial of PCV24 in Children Aged 2 Months (Minimum 6 Weeks) to 17 Years

Phase I Clinical Trial Protocol of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) to Evaluate the Safety and Immunogenicity in Children Aged 2 Months (Minimum 6 Weeks) to 17 Years

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Shanghai Reinovax Biologics Co.,LTD · Industry
• Sex: All
• Age: 6 Weeks – 17 Years
• Healthy volunteers: Accepted

Summary

Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in children aged 2 Months (Minimum 6 Weeks) to 17 Years . The objective of the study is to evaluate the safety tolerability and immunogenicity of PCV24. The trial is a randomized, blind, controlled combined placebo and positive vaccine control I clinical trial.

Conditions

• Pneumococcal Infectious Disease

Interventions

Type	Name	Description
BIOLOGICAL	PCV24 formulation 1	24-Valent Pneumococcal Polysaccharide Conjugate Vaccine formulation 1：Dosage form: Injection Specification:0.5 ml/strip Dosage: The preferred site is the anterolateral thigh (lateral femoral muscle) in infants and the deltoid muscle of the upper arm in infants and children. The preferred dosage for infants is 0.5 ml per dose. Dosing schedule:24 months old-17 years old group: 1 dose.12-23 months old group: 2 doses, each dose at least 2 months apart.7-11 months old group: 2 doses of basic immunization, the first two doses at least 1 month apart, and a booster dose after 12 months of age.6 weeks months: 1 dose of basic immunization at each of the ages of 2, 4, and 6 months, and 1 dose of booster immunization at the age of 12-15 months, with the earliest of the first dose at the age of 6 weeks. The first dose is given at 6 weeks of age at the earliest.
BIOLOGICAL	PCV24 formulation 2	24-Valent Pneumococcal Polysaccharide Conjugate Vaccine formulation 2：Dosage form: Injection Specification:0.5 ml/strip Dosage: The preferred site is the anterolateral thigh (lateral femoral muscle) in infants and the deltoid muscle of the upper arm in infants and children. The preferred dosage for infants is 0.5 ml per dose. Dosing schedule:24 months old-17 years old group: 1 dose.12-23 months old group: 2 doses, each dose at least 2 months apart.7-11 months old group: 2 doses of basic immunization, the first two doses at least 1 month apart, and a booster dose after 12 months of age.6 weeks months: 1 dose of basic immunization at each of the ages of 2, 4, and 6 months, and 1 dose of booster immunization at the age of 12-15 months, with the earliest of the first dose at the age of 6 weeks. The first dose is given at 6 weeks of age at the earliest.
BIOLOGICAL	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine:Dosage form: Injection Specification:0.5 mL/strip Dosage: The preferred site for infants is the anterolateral thigh (lateral femoral muscle), and for toddlers and children, the deltoid muscle of the upper arm. Dosing schedule:6 weeks months: 4 doses, one dose each of basic immunization at 2, 4, and 6 months of age, and one dose of booster immunization at 12-15 months of age, with the earliest of the first dose being given at 6 weeks of age. The first dose should be given at 6 weeks of age at the earliest.
BIOLOGICAL	Sodium Chloride Injection	Sodium Chloride Injection：Dosage form: Injection Specification:0.5 ml/strip Dosage: The preferred site is the anterolateral thigh (lateral femoral muscle) in infants and the deltoid muscle of the upper arm in infants and children. The preferred dosage for infants is 0.5 ml per dose. Dosing schedule:24 months old-17 years old group: 1 dose.12-23 months old group: 2 doses, each dose at least 2 months apart.7-11 months old group: 2 doses of basic immunization, the first two doses at least 1 month apart, and a booster dose after 12 months of age.6 weeks months: 1 dose of basic immunization at each of the ages of 2, 4, and 6 months, and 1 dose of booster immunization at the age of 12-15 months, with the earliest of the first dose at the age of 6 weeks. The first dose is given at 6 weeks of age at the earliest.

Timeline

• Start date: 2024-04-27
• Primary completion: 2025-05-10
• Completion: 2026-03-01
• First posted: 2024-11-05
• Last updated: 2025-12-26

Locations

1 site across 1 country: China