Pneumococcal Infectious DiseasePhase 1NCT06550830

Clinical Trial of PCV24 in Children Aged 2-17 Years

A Phase 1 study testing Sinovac PCV24 formulation 1, Sinovac PCV24 formulation 2 and Prevenar13® in people with Pneumococcal Infectious Disease, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. Read more about this study

Who is it for?: Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infectious Disease
What is being tested?: Sinovac PCV24 formulation 1, Sinovac PCV24 formulation 2 and Prevenar13®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteChina
Study dates: 7 Sep 2024to 25 Jun 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy volunteers who are aged 2-17 years;
Participants and their guardians provide legal proof of identity, as well as vaccination record (for children aged 2-5 years);
Participants' guardians understand and voluntarily sign the informed consent form; participants aged 8-17 years sign the written assent;
Participants can follow all study procedures and stay in contact during the study.

Who cannot join

Received any pneumococcal vaccine prior to enrollment;
History of invasive pneumococcal diseases (IPDs) or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock;
Congenital malformations or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, such as cardiovascular diseases (e.g. congenital heart disease), metabolic diseases (such as diabetes), hematological diseases (e.g. severe anemia),liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection)

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Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
Long-term alcohol or drug abuse.
Have received > 14 days of immunosuppressive or other immunomodulatory therapy in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period.
Received immunoglobulin or other blood products within 3 months prior to enrollment, or plan to receive such treatment during the study period;
Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
Received live attenuated vaccine within 14 days prior to enrollment;
Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection;
Women who are pregnant or breastfeeding (if applicable);
Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant.
Had fever (axillary temperature> 37.0℃) before vaccination;
In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Nanjing, Jiangsu

Other trials in China

About this study

Official title: A Randomized, Double-blind, Controlled Combined With Open-label Phase Ia Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2-17 Years.

Read the detailed description

A phase Ia clinical trial of the study of 24-valent Pneumococcal Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children aged 2-17 years. The trial is a randomized, double-blind, controlled combined with open-label study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine for participants aged 2-5 years is the Prevenar13® manufactured by Pfizer.

A total of at least 114 participants will be enrolled, including 24 children aged 6-17 years and 90 children aged 2-5 years. Children aged 6-17 years will receive PCV24 formulation 1 and PCV24 formulation 2 in a 1:1 ratio. Children aged 2-5 years will receive PCV24 formulation 1, PCV24 formulation 2 and Prevenar13® in a 1:1:1 ratio.

Conditions: Pneumococcal Infectious Disease
Being tested: Sinovac PCV24 formulation 1, Sinovac PCV24 formulation 2, Prevenar13®
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sinovac PCV24 formulation 1Biological
One dose of Sinovac PCV24 formulation 1(0.5mL)
Sinovac PCV24 formulation 2Biological
One dose of Sinovac PCV24 formulation 2(0.5mL)
Prevenar13®Biological
One dose of PCV13 manufactured by Pfizer

Study groups in NCT06550830
Study group	Role	What they receive
Experimental group 1	Experimental	12 participants aged 6-17 years and 30 participants aged 2-5 years will be randomized to receive Sinovac PCV24 formulation 1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. Receives: Biological: Sinovac PCV24 formulation 1
Experimental group 2	Experimental	12 participants aged 6-17 years and 30 participants aged 2-5 years will be randomized to receive Sinovac PCV24 formulation 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. Receives: Biological: Sinovac PCV24 formulation 2
Active control group	Active comparator	30 participants aged 2-5 years will be randomized to receive Prevenar13®. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. Receives: Biological: Prevenar13®

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination
Measured: 0-30 days after vaccination

Secondary outcomes (12)

Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Measured: 0-7 days after vaccination
Incidence of serious adverse events (SAE)
Incidence of SAE during the period of safety monitoring
Measured: 0-6 months after vaccination
Incidence of clinically significant abnormality in laboratory examination tests
Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination
Measured: 0-3 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC 30 days after vaccination
Measured: 30 days after vaccination
Proportion of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of IgG antibody concentration ≥0.35 μg/ml
Measured: 30 days after vaccination
Proportion of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml
Proportion of IgG antibody concentration ≥1.0 μg/ml
Measured: 30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
IgG GMI 30 days after vaccination
Measured: 30 days after vaccination
Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4
Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination
Measured: 30 days after vaccination
Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs)
OPA GMT 30 days after vaccination
Measured: 30 days after vaccination
Pneumococcal serotype-specific OPA GMI
OPA GMI 30 days after vaccination
Measured: 30 days after vaccination
Proportion of Pneumococcal serotype-specific OPA GMT≥1:8
Proportion of Pneumococcal serotype-specific OPA GMT≥1:8 30 days after vaccination
Measured: 30 days after vaccination
Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4
Proportion of OPA antibody titer increase≥four folds 30 days after vaccination
Measured: 30 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 202425 Jun 2025

First posted13 Aug 2024
Study start7 Sep 2024
Primary completion25 Jun 2025
Study completion25 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pneumococcal Infectious DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06550830
Sponsor's protocol ID: PRO-PCV24-1002
Status last verified: Jan 2026
First submitted: 8 Aug 2024
Last updated: 28 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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