PCV24 Clinical Trial in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months

January 14, 2026 updated by: Shanghai Reinovax Biologics Co.,LTD

Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of A 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months

The Phase II clinical trial of the 24-valent pneumococcal polysaccharide conjugate vaccine (RZ700) will be carried out in infants and young children aged 2 months (minimum 6 weeks) to 71 months. The purpose of this study is to evaluate the immunogenicity and safety of the 24-valent pneumococcal polysaccharide conjugate vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Principal Investigator ，Yunong Zhang，Master
  • Phone Number: 13485383983
  • Email: 474584051@qq.com

Study Locations

  • China
    • Shanxi
      • Changzhi, Shanxi, China, 046011
        • Recruiting
        • Luzhou District Center for Disease Control and Prevention
        • Contact:
          • Xiaoqin Chen
          • Phone Number: 13903558980
      • Changzhi, Shanxi, China, 046400
        • Recruiting
        • Qinxian County Center for Disease Control and Prevention
        • Contact:
          • Gang FU
          • Phone Number: 13835542153
      • Yangquan, Shanxi, China, 045000
        • Recruiting
        • Kuangqu District Center for Disease Control and Prevention of Yangquan City
        • Contact:
          • Aiying Gao
          • Phone Number: 15835310186
      • Yuncheng, Shanxi, China, 043100
        • Recruiting
        • Xinjiang County Center for Disease Control and Prevention
        • Contact:
          • Hong Ji
          • Phone Number: 13934866181
      • Yuncheng, Shanxi, China, 043200
        • Recruiting
        • Jishan County Center for Disease Control and Prevention
        • Contact:
          • Pinggui Zheng
          • Phone Number: 13834393583
      • Yuncheng, Shanxi, China, 044500
        • Recruiting
        • Yongji City Center for Disease Control and Prevention
        • Contact:
          • Xin Teng
          • Phone Number: 18735931088
      • Yuncheng, Shanxi, China, 047100
        • Recruiting
        • Shangdang District Center for Disease Control and Prevention of Changzhi City
        • Contact:
          • Yanling Han
          • Phone Number: 18613552325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy subjects aged 2 months (minimum 6 weeks) and 7-71 months, whose guardians can provide valid identification documents for both the subjects and themselves, as well as proof of their guardianship relationship.
  • The guardians of the subjects voluntarily agree to their participation in this trial, sign the Informed Consent Form (ICF), and are willing to comply with all requirements of this clinical trial protocol.
  • The guardians of the subjects have the ability to understand the trial procedures (non-illiterate).

Exclusion Criteria:

  • Subjects who have received any type of pneumococcal vaccine prior to enrollment, plan to receive a pneumococcal vaccine during the trial, or have a history of invasive diseases caused by Streptococcus pneumoniae (confirmed by any clinical, serological, or microbiological method).
  • Subjects with abnormal physical examination results that are deemed clinically significant by a clinician.
  • Subjects with suspected or confirmed fever (axillary temperature ≥ 37.5℃) within 3 days prior to enrollment; or those with an axillary temperature ≥ 37.5℃ on the day before the first dose of vaccination.
  • Subjects with a history of acute illness, acute exacerbation of chronic illness, systemic use of antibiotics or antiviral drugs within 3 days prior to the first dose of vaccination; or those who have taken antipyretic, analgesic, or antiallergic drugs (e.g., acetaminophen, ibuprofen, loratadine, cetirizine, etc.) within 3 days prior to the first dose of vaccination.
  • Subjects with a history of allergy to any component of the study vaccine, any vaccine containing tetanus toxoid, or a previous history of severe allergy to any vaccine or drug (including but not limited to anaphylactic shock, allergic laryngeal edema, allergic purpura, immune thrombocytopenic purpura, local allergic necrotizing reaction, dyspnea, angioedema, etc.); or a previous history of the aforementioned severe adverse reactions following the use of any vaccine or drug.
  • Subjects who have received inactivated vaccines, subunit vaccines, or recombinant vaccines within 7 days prior to enrollment; or live attenuated vaccines, adenovirus vector vaccines, etc., within 14 days prior to enrollment.
  • Subjects who have received any other investigational drugs within 3 months prior to enrollment or plan to use them during the trial; those who have received whole blood, plasma, or blood products (e.g., immunoglobulin therapy) within 3 months prior to enrollment or plan to receive such treatments during the trial.
  • Subjects with a history of thrombocytopenia, idiopathic thrombocytopenic purpura, or other coagulation disorders diagnosed by a hospital; or a history of receiving anticoagulant therapy.
  • Subjects with a known current or past history of infectious diseases diagnosed by a hospital, such as active tuberculosis, hepatitis B, hepatitis C, HIV infection, etc.
  • Subjects with known or suspected severe chronic diseases (e.g., liver and kidney diseases, malignant tumors, infectious or allergic skin diseases, hemolytic uremic syndrome); or those whose condition is in the progressive stage and cannot be stably controlled.
  • Infants aged 2 months (minimum 6 weeks) and 7-11 months with abnormal birth weight (<2500g), abnormal gestational age (<37 weeks or >42 weeks), abnormal delivery (dystocia, instrumental delivery), or a history of asphyxia or neuroorganic damage.
  • Infants aged 2 months (minimum 6 weeks) and 7-11 months with severe eczema or severe jaundice (grade 3 or above).
  • Subjects with severe congenital malformations, developmental disorders, genetic defects, severe malnutrition, or severe chronic diseases (e.g., tetralogy of Fallot, tricuspid atresia, Down syndrome, sickle cell anemia, etc.).
  • Subjects with neurological diseases or neurodevelopmental disorders (e.g., febrile convulsions, epilepsy, encephalopathy, focal neurological deficits, encephalomyelitis or transverse myelitis, Guillain-Barré syndrome); or a history of mental illness in the subjects themselves or their biological parents.
  • Subjects with a history of congenital or acquired immunodeficiency, immunosuppression, or autoimmune diseases; or those who have received immunomodulatory therapy within 6 months (e.g., immunosuppressive doses of glucocorticoids [dosage reference: equivalent to prednisone ≥0.5mg/kg/day for more than 2 weeks], monoclonal antibodies, thymopeptides, interferons, etc.); or plan to receive such treatments from enrollment to 30 days after the last dose of vaccination. Topical medications (e.g., ointments, eye drops, inhalants, or nasal sprays) are permitted.
  • Subjects with asplenia, functional asplenia, or asplenia/resplenectomy caused by any condition.
  • Subjects whose guardians may be unable to comply with trial procedures, adhere to agreements, plan to permanently relocate from the region before the trial is completed, or be away from the local area for a long time during scheduled visits.
  • Researchers believe that the subject has any other factors that make them unsuitable for participating in the clinical trial, such that continued participation cannot ensure the subject's maximum benefit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort I :2 months (minimum 6 weeks）of age.
Subjects aged 2 months (minimum 6 weeks) will receive the experimental vaccine or comparator control vaccine according to 0, 2, and 4-month immunization schedule, followed by a booster dose at 12-15 months of age.
Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700)
24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) consisting of polysaccahrides from 24 pneumococcal serotypes: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F conjugated two carrier proteins. Each dose contains 0.5 ml vaccine in a prefilled syringe.
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) consisting of plosaccharides from 13 pneumococcal serotypes: 1, , 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F conjugated CRM197. Each dose contains 0.5 ml vaccine in a prefilled syringe.
Experimental: Cohort II : 7~23 months of age.
Subjects aged 7-11 months will receive the experimental vaccine or comparator control vaccine according to the 0 and 2-month immunization schedule. A booster dose will be administered at 12-15 months of age. Accprdingly, subjects aged 12-23 months will receive the experimental vaccine or comparator control vaccine according to the 0 and 2-month immunization schedule.
Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700)
24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) consisting of polysaccahrides from 24 pneumococcal serotypes: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F conjugated two carrier proteins. Each dose contains 0.5 ml vaccine in a prefilled syringe.
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) consisting of plosaccharides from 13 pneumococcal serotypes: 1, , 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F conjugated CRM197. Each dose contains 0.5 ml vaccine in a prefilled syringe.
Experimental: Cohort III : 24~71 months of age.
Subjects aged 24-71 months will receive a single intramuscular injection of the experimental vaccine or comparator control vaccineon the day of enrollment.
Biological: 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700)
24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) consisting of polysaccahrides from 24 pneumococcal serotypes: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F conjugated two carrier proteins. Each dose contains 0.5 ml vaccine in a prefilled syringe.
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) consisting of plosaccharides from 13 pneumococcal serotypes: 1, , 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F conjugated CRM197. Each dose contains 0.5 ml vaccine in a prefilled syringe.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml.
Time Frame: 30 days post the primary and booster immunization.
Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml.
30 days post the primary and booster immunization.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of subjects with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae.
Time Frame: 30 days after completion of the primary immunization schedule
The proportion of subjects aged 2 months (minimum 6 weeks old) and 7~71 months old with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae.
30 days after completion of the primary immunization schedule
The proportion of subjects with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae.
Time Frame: 30 days after completion of the booster immunization schedule
The proportion of subjects aged 2 months (minimum 6 weeks old) and 7~11 months old with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae.
30 days after completion of the booster immunization schedule
The proportion of subjects with serum MOPA titer ≥1:8 against Streptococcus pneumoniae.
Time Frame: 30 days after vaccination
The proportion of subjects in the MOPA testing subgroup aged 24~71 months with serum MOPA titer ≥1:8 against Streptococcus pneumoniae.
30 days after vaccination
Geometric Mean Titer (GMT) of pneumococcal serotype-specific MOPA antibodies in serum.
Time Frame: 30 days after vaccination
Pneumococcal serotype-specific MOPA geometric mean titer (GMT) in serum of subjects aged 24~71 months in the MOPA testing subgroup.
30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean fold rise (GMFR) against 24 serotypes post immunization compared with pre-immunization.
Time Frame: 30 days after completion of the primary immunization schedule.
Pneumococcal serotype-specific IgG antibody geometric mean fold rise (GMFR) against 24 serotypes in subjects aged 2 months (minimum 6 weeks old) and 7~71 months old compared with pre-immunization.
30 days after completion of the primary immunization schedule.
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) .
Time Frame: 30 days after completion of the primary immunization schedule
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) for each serotype (1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F) in subjects aged 2 months (minimum 6 weeks old) and 7~71 months old at 30 days after completion of the primary immunization.
30 days after completion of the primary immunization schedule
Pneumococcal serotype-specific MOPA geometric mean titer fold rise (GMFR) in serum.
Time Frame: 30 days after vaccination
Pneumococcal serotype-specific MOPA geometric mean titer fold rise (GMFR) in serum of subjects aged 24~71 months in the MOPA testing subgroup.
30 days after vaccination
Incidence rate of all adverse events (AEs).
Time Frame: Within 30 days after each dose of vaccination
Incidence rate of all adverse events (AEs) within 30 minutes, 7 days, and 30 days after each dose of vaccination in each age group.
Within 30 days after each dose of vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).
Time Frame: From the first dose of vaccination to 6 months after completion of the full vaccination course
12~71 months old: Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).
From the first dose of vaccination to 6 months after completion of the full vaccination course
Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).
Time Frame: From the first dose of the primary immunization course to 6 months after completion of the booster immunization
2 months old (minimum 6 weeks old)and 7 to 11 months old: Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs).
From the first dose of the primary immunization course to 6 months after completion of the booster immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Reinovax Biologics Co.,LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yunong Zhang, Master, Shanxi Province Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNCVCT7B002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumococcal Infectious Disease

Clinical Trials on 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings