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

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

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.

Sponsors & Collaborators

• Shaanxi Provincial Center for Disease Control and Prevention

  collaborator OTHER

• Shanghai Reinovax Biologics Co.,LTD

  lead INDUSTRY

Principal Investigators

• Yunong Zhang, Master · Shanxi Province Center for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-27

Primary Completion

2025-05-10

Completion

2026-03-31

Countries

• China

Study Locations