230
Participants
Start Date
April 27, 2024
Primary Completion Date
February 28, 2026
Study Completion Date
March 31, 2026
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."
PCV24 formulation 2
"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."
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."
Sodium Chloride Injection
"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."
Luzhou District Center for Disease Control and Prevention, Changzhi City, Changzhi
Principal Investigator:Yu nong Zhang,Shanxi Provincial Center for Disease Control and Prevention
UNKNOWN
Shanghai Reinovax Biologics Co.,LTD
INDUSTRY