Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

January 26, 2026 updated by: Sinovac Life Sciences Co., Ltd.

An Open-label Combined Randomized Double-blind, Positive Control Clinical Trial in Subjects Aged 2 Months (Minimum 6 Weeks) and Above to Preliminary Evaluate the Safety and Immunogenicity of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine

Study Overview

Status

Status

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

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.

Detailed Description

This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial in subjects aged 2 months (minimum 6 weeks) and above. The experimental vaccine was manufactured by Sinovac Research & Development Co., Ltd. .And one of the positive control vaccine was manufactured by WALVAX Biotechnology Co., Ltd( WALVAX PCV13) ,the other manufactured by Pfizer(Pfizer PCV13).A total of 310 subjects including 20 adults aged 18-49 years,20 adolescents and children aged 6~7 years ,60 children aged 2-5 years,60 infants aged 12~23 months,60 infants aged 7 ~11 months,60 infants aged 2 months (minimum 6 weeks), and 30 infants aged 3 months will be enrolled.Subjects will be assigned to receive one dose , two doses ,three doses or four doses of experimental vaccine or different positive control vaccines . Subjects aged 18-49 years will receive one dose of experimental vaccine.Subjects aged 6~17 years will receive one dose of experimental vaccine.Subjects aged 2~5 years will be randomly divided into two groups in a ratio of 1:1,and each group will receive one dose of experimental vaccine or control vaccine(WALVAX PCV13）.Subjects aged 7 ~ 11 months and subjects aged 12 ~23 months will be randomly divided into two groups in a 1:1 ratio,the subjects aged 12 ~ 23 months will receive two doses of experimental vaccine or control vaccine on the schedule of month 0,2 .Subjects aged 7 ~11 months will receive 3 doses of experimental vaccine or control vaccine (WALVAX PCV13）on the immunization schedule of month 0,2,4.Subjects aged 3 months will receive 4 doses of experimental vaccine.Subjects aged 2 months will be randomly divided into 2 groups in a 1:1 ratio and each group will receive 4 doses of experimental vaccine or control vaccine (Pfizer PCV13).

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 (Actual)

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.
310

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 1

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.

Study Contact Backup

  • Name: Shengli Xia, Master
  • Phone Number: 13592610137

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Henan Center for Diseases Control and Prevention

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

1 month to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 ~ 11 months, healthy infants aged 12~ 23 months, healthy children aged 2~ 5 years, healthy adolescent and children aged 6~ 17 years, healthy adults aged 18~ 49 years；
  • Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below)；
  • The subject and/or guardian can understand and voluntarily sign the informed consent form.

Exclusion Criteria:

  • Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine;
  • Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture;
  • History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • History of thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
  • Axillary temperature >37.0°C;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

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: Double

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: Experimental Group of One Dose
110 Participants (including 20 subjects aged 18~49 years, 20 subjects aged 6~17 years , 30 subjects aged2-5 years) will receive one dose of experimental vaccine
Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
The investigational vaccine was manufactured by Sinovac Research & Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.
Experimental: Experimental Group of Two Doses
30 Participants aged 12~23 months will receive two doses of experimental vaccine on the schedule of month 0,2.
Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
The investigational vaccine was manufactured by Sinovac Research & Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.
Experimental: Experimental Group of Three Doses
30 Participants aged 7~11 months will receive two doses of experimental vaccine on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months .
Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
The investigational vaccine was manufactured by Sinovac Research & Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.
Experimental: Experimental Group of Four Doses
30 Participants aged 3 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,1,2 and one dose of booster immunization during the participants aged 12~15 months ; 30 Participants aged 2 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months
Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
The investigational vaccine was manufactured by Sinovac Research & Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.
Active Comparator: Control Group of One Dose With WALVAX PCV13
30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13)
Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.
Active Comparator: Control Group of Two Doses With WALVAX PCV13
30 Participants aged 12~23 months will receive two doses of control vaccine(WALVAX PCV13) on the schedule of month 0,2.
Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.
Active Comparator: Control Group of Three Doses With WALVAX PCV13
30 Participants aged 7~11 months will receive two doses of control vaccine(WALVAX PCV13) on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months .
Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.
Active Comparator: Control Group of Three Doses With Pfizer PCV13
30 Participants aged 2 months will receive three doses of control vaccine(Pfizer PCV13 on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months
Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)
The control vaccine was manufactured by Pfizer. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,sodium chloride ,succinic acid ,polysorbate 80 and water for injection per injection.

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
Safety index-incidence of adverse reactions
Time Frame: Day 0-30 after each dose of experimental vaccine
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine
Day 0-30 after each dose of experimental vaccine

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
Safety index-incidence of adverse reactions
Time Frame: Day 0-7 after each dose of experimental vaccine
Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine
Day 0-7 after each dose of experimental vaccine
Safety index-incidence of abnormal indicators
Time Frame: Day 3 after vaccination after each dose of experimental vaccine
Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older
Day 3 after vaccination after each dose of experimental vaccine
Safety index-Incidence of serious adverse events during the safety observation period
Time Frame: 1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
Incidence of serious adverse events during the safety observation period, including 1 month after vaccination in subject aged 6 years and older, and 6 months after primary immunization and 1 month after booster immunization in subject aged 2 months (minimum 6 weeks) to 5 years(if any)
1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
Time Frame: Day 30 after vaccination
Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype at 30 days after vaccination in subjects of all age groups
Day 30 after vaccination
Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
Time Frame: Day 30 after vaccination
Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype at 30 days after vaccination in subjects of all age groups
Day 30 after vaccination
Immunogenicity index-Seropositive rates，GMCs and GMI of serum specific antibody
Time Frame: Day 30 after vaccination
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMCs) and GMI of serum specific antibody at 30 days after primary immunization in subjects of all age groups
Day 30 after vaccination
Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)
Time Frame: Day 30 after vaccination
Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)in subjects of all age groups at 30 days after primary immunization
Day 30 after vaccination
Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)
Time Frame: Day 30 before and after booster immunization
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC) in subjects aged 2 months (Minimum 6 weeks), 3 months and 7 ~ 11 months at 30 days before and after booster immunization
Day 30 before and after booster immunization
Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)
Time Frame: Day 30 before and after booster immunization
Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT) in subjects aged 2 months (Minimum 6 weeks), 3 months, and 7~ 11 months at 30 days before and after booster immunization
Day 30 before and after 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.
Sinovac Life Sciences 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: Yanxia Wang, Master, Henan Provincial Center for Disease Prevention and Control

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.
January 3, 2023

Primary Completion (Actual)

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.
May 26, 2024

Study Completion (Actual)

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.
May 28, 2024

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).
October 13, 2021

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.
October 13, 2021

First Posted (Actual)

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.
October 25, 2021

Study Record Updates

Last Update Posted (Actual)

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 28, 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 26, 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.
  • PRO-PCV-1001

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.

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