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

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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

NCT06675032•Shanghai Reinovax Biologics Co.,LTD

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 17 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy subjects aged 2\~3 months (minimum 6 weeks old) and 7 months old\~17 years old, and the guardian of the subject can provide valid identification of the subject and the guardian of the subject.
•Subjects and/or their guardians voluntarily consent to the subjects to participate in this study and sign the informed consent form.
•Subjects and/or their guardians have the ability to understand (non-illiterate) study procedures.
•Female subjects and male subjects of childbearing age agree to use effective contraceptive measures within 6 months from the start of the study to the date of immunization.
•Those who have completed the full course of primary immunization in accordance with the requirements of this clinical trial, and the age before the booster immunization is 12\~15 months old, (the interval between the booster immunization time and the last dose of primary immunization is at least 2 months).
•In the opinion of the investigator, the subject's guardian can comply with all the requirements of this clinical trial protocol during the booster phase of the subject.

Exclusion Criteria

•Individuals who have previously received any type of pneumococcal vaccine or have a history of invasive disease caused by Streptococcus pneumoniae (confirmed by clinical, serological, or microbiological methods).
•Abnormal results from physical examinations or laboratory tests that are deemed clinically significant by a clinician.
•Individuals suspected or diagnosed with fever (axillary temperature ≥37.5℃) within 3 days prior to enrollment; or axillary temperature ≥37.3℃ (for those over 14 years old) or ≥37.5℃ (for those 14 years old or younger) on the day of the first vaccine dose.
•Within 7 days prior to the first dose of vaccination, there is a history of acute illness or acute exacerbation of chronic disease, and systemic application of antibiotics and antiviral medications has been administered; within 3 days prior to the first dose of vaccination, antipyretics, analgesics, and antihistamines (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) have been taken.
•A history of severe allergy to any component of the vaccine being tested, or a history of severe allergy to any vaccine containing tetanus toxoid, or a previous history of severe allergy to any vaccine or medication (including but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reactions, difficulty breathing, angioedema, etc.); or a previous history of severe adverse reactions after the use of any vaccine or medication.
•Subjects who have received inactivated vaccines, subunit vaccines, or recombinant vaccines within 7 days prior to enrollment in the study, or who have received live attenuated vaccines or adenoviral vector vaccines within 14 days prior to enrollment in the study.
•Participants who have received or plan to use any other investigational drug within 3 months prior to the study; those who have received whole blood, plasma, and/or blood products, such as immunoglobulin treatment, within the last 3 months.
•History of thrombocytopenia or other coagulation disorders diagnosed by a hospital, or history of anticoagulant treatment.
•Known to have a current or past history of infectious diseases, such as active tuberculosis, hepatitis B, hepatitis C, and/or human immunodeficiency virus (HIV) infection.
•Known or suspected to have serious chronic diseases, such as liver and kidney diseases, malignant tumors, infections, or allergic skin diseases; or those whose condition is in a progressive stage and cannot be stably controlled.
+34 more criteria

Locations (1)

Luzhou District Center for Disease Control and Prevention, Changzhi City

Changzhi, Shanxi, China

Key Dates

Start Date

April 27, 2024

Primary Completion Date

May 10, 2025

Completion Date

March 1, 2026

Last Updated

December 26, 2025

Enrollment

230

ESTIMATED participants

Conditions

Pneumococcal Infectious Disease

Interventions

PCV24 formulation 1

BIOLOGICAL

PCV24 formulation 2

BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

BIOLOGICAL

Sodium Chloride Injection

BIOLOGICAL

A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population

NCT07071701

Pneumococcal Infectious Disease

View study

COMPLETEDPHASE3

Safety and Immunogenicity of a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children

NCT02285036

Pneumococcal Infectious Diseases

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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