A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

January 26, 2026 updated by: Sinovac Research and Development Co., Ltd.

A Randomized, Double Blinded, Positive Controlled Phase Ⅰb Clinical Trial in Participants Aged 2 Months (42-89 Days) and 2 to 5 Years to Evaluate the Safety and Immunogenicity of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV13. The trial is a randomized, double blinded, positive controlled study.

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

A phase Ⅰb clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children aged 2 months (42-89 days) and 2 to 5 years. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is the PREVNAR 13 manufactured by Pfizer Inc. A total of 140 participants will be enrolled, including 70 children aged 2-5 years old, and 70 infants aged 2 months (42-89 days). Participants will be randomized to receive either Sinovac PCV13 or Pfizer PCV13 in a 1:1 ratio. Children aged 2-5 years old will receive 1 dose; Infants aged 2 months will receive 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months.

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.
140

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 Locations

  • China
    • Yunnan
      • Dali, Yunnan, China, 671600
        • Binchuan County 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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy infants aged 2 months (42-89 days); Healthy children aged 2-5 years.
  2. Proven vaccination certificate, birth certificate and legal identification documents
  3. The participants' guardians can understand and voluntarily sign the informed consent form.
  4. Participants and their guardians can obey requirements of the protocol.

Exclusion Criteria:

  1. Received any pneumococcal vaccine prior to enrollment.
  2. History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae.
  3. History of allergy to the vaccine or vaccine components, including pneumococcal polysaccharide for each serotype, diphtheria CRM197, aluminum phosphate, succinic acid, polysorbate 80 and sodium chloride; or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma.
  4. History of dystocia, asphyxia rescue, nervous system damage at birth (only applicable to infants aged 2 months (42-89 days))
  5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, asthma etc.
  6. Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/ immunosuppression (such as HIV, organ transplantation)
  7. Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases, malignant tumors.
  8. Family history of mental illness, severe neurological disease (epilepsy or convulsions) or mental illness.
  9. History of thyroidectomy, asplenia, functional asplenia; and asplenia or splenectomy resulting from any condition.
  10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets), history of obvious bleeding or bruising after intramuscular injection or venipuncture.
  11. Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 6 months prior to enrollment had been treated with corticosteroids, other immunosuppressive agents (excluding corticosteroid spray therapy for allergic rhinitis, superficial corticosteroid therapy for acute non-concurrent dermatitis) or cytotoxic therapy for ≥14 days
  12. Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 3 months prior to enrollment received blood products within the past 3 months (excluding hepatitis B immunoglobulin within 1 month).
  13. Receipt of other investigational drugs in the past 60 days or have the plan to participate in other clinical trials during this study.
  14. Receipt of attenuated live vaccines in the past 14 days.
  15. Receipt of inactivated or subunit vaccines in the past 7 days.
  16. Acute diseases or acute exacerbation of chronic diseases in the past 7 days.
  17. Axillary temperature ≥37.3 °C.
  18. 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: Quadruple

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: Infants aged 2 months in experimental group
35 participants aged 2 months will be randomized to receive Sinovac PCV13. Route of administration is intramuscular injection at anterolateral aspect of thigh; immunization schedule is 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months.
Biological: Sinovac PCV13
0.5 mL dose of Sinovac PCV13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Active Comparator: Infants aged 2 months in control group
35 participants aged 2 months will be randomized to receive PREVNAR 13. Route of administration is intramuscular injection at anterolateral aspect of thigh; immunization schedule is 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months.
Biological: PREVNAR 13
0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Experimental: Children aged 2-5 years in experimental group
35 children aged 2-5 years will be randomized to receive Sinovac PCV13. The route of administration is intramuscular injection at deltoid muscle of the upper arm, and immunization schedule is 1 dose for children aged 2-5 years old.
Biological: Sinovac PCV13
0.5 mL dose of Sinovac PCV13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Active Comparator: Children aged 2-5 years in control group
35 children aged 2-5 years will be randomized to receive PREVNAR 13. The route of administration is intramuscular injection at deltoid muscle of the upper arm, and immunization schedule is 1 dose for children aged 2-5 years old.
Biological: PREVNAR 13
0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

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
Incidence of adverse reactions
Time Frame: 0-30 days after each dose
Incidence of adverse reactions within 30 days after each dose
0-30 days after each dose

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
Incidence of adverse reactions
Time Frame: 0-7 days after each dose
Incidence of adverse reactions within 7 days after each dose
0-7 days after each dose
Incidence of SAE
Time Frame: 6 months after vaccination for children aged 2-5 years; 1 month after completion of booster vaccination for infants aged 2 months.
Incidence of SAE during the period of safety monitoring
6 months after vaccination for children aged 2-5 years; 1 month after completion of booster vaccination for infants aged 2 months.
IgG concentration ≥0.35μg/mL for infants aged 2 months
Time Frame: 30 days after primary/booster immunization
The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after primary/booster immunization.
30 days after primary/booster immunization
IgG concentration ≥1.0μg/mL for infants aged 2 months
Time Frame: 30 days after primary/booster immunization
The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after primary/booster immunization.
30 days after primary/booster immunization
GMCs for infants aged 2 months
Time Frame: 30 days after primary/booster immunization
GMCs for each serotype 30 days after primary/booster immunization
30 days after primary/booster immunization
GMIs for infants aged 2 months
Time Frame: 30 days after primary/booster immunization
GMIs (GMC increase folds) for each serotype 30 days after primary/booster immunization
30 days after primary/booster immunization
IgG concentration ≥0.35μg/mL for children aged 2-5 years
Time Frame: 30 days after vaccination
The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after vaccination.
30 days after vaccination
IgG concentration ≥1.0μg/mL for children aged 2-5 years
Time Frame: 30 days after vaccination
The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after vaccination.
30 days after vaccination
GMCs for children aged 2-5 years
Time Frame: 30 days after vaccination
GMCs for each serotype 30 days after vaccination
30 days after vaccination
GMIs for children aged 2-5 years
Time Frame: 30 days after vaccination
GMIs (GMC increase folds) for each serotype 30 days after vaccination
30 days after vaccination

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 Research and Development 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: Yan Zheng, Yunnan 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 4, 2024

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.
March 26, 2025

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.
March 26, 2025

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 13, 2023

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 13, 2023

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.
December 27, 2023

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-1002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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