Pneumococcal Infectious DiseasePhase 2NCT07300644
Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years
A Phase 2 study testing Sinovac PCV24 and Prevnar® in people with Pneumococcal Infectious Disease, run by Sinovac Life Sciences Co., Ltd. at 3 sites in China.
Trial summary
A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 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 42 days to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infectious Disease
- What is being tested?
- Sinovac PCV24 and Prevnar®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 3 sitesChina
- Study dates
- 25 Nov 2025to Dec 2027
- Phase
- Phase 2
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 42 days to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months, and 2-5 years;
- The participants' guardian provides a legal identity document and the participants' vaccination record;
- The participant's guardian understands and voluntarily signs the informed consent form;
- 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 or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
- History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
- Low birth weight (<2.5kg), or premature infant (gestation weeks < 37 weeks) (applies to infants younger than 12 months);
- History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);
- Severe congenital malformations or developmental disorders, genetic defects, or malnutrition;
Show all 18Show fewer
- Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), 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, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelet levels);
- Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but a febrile convulsion is not an exclusion criteria ) or mental illness, or have a family history of such diseases;
- Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study;
- Receipt of immunoglobulins or other blood products within 3 months prior to administration of the investigational vaccine (except for hepatitis B immunoglobulin or rabies immunoglobulin used within 1 month), or planned use of such products 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 vaccine within 7 days prior to enrollment;
- Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;
- Axillary temperature≥ 37.3 Degree Celsius 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Qichun District Center for Disease Prevention and Control
Huanggang, Hubei
Jun Xu, 18934639763, 554576525@qq.com
- Recruiting
Xiangzhou District Center for Disease Prevention and Control
Xiangyang, Hubei
Gaofeng Yan, 13487111114, 113377121@qq.com
- Recruiting
Xian'an District Center for Disease Prevention and Control
Xianning, Hubei
Youfang Qian, 13476880711, 1048870562@qq.com
About this study
Official title: A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 Months (Minimum 42 Days) to 5 Years
A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 years.
The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase 2 clinical trial.
Read the detailed description
A phase 2 clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in the Chinese pediatric population aged 2 months (minimum 42 days) to 5 years. The trial is a randomized, double-blind, positive-controlled 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 is Prevenar13®, manufactured by Pfizer.
A total of at least 420 participants aged 2 months (minimum 42 days) to 5 years will be enrolled. Participants will be randomized in a 1:1 ratio to the test group and control group.
- Conditions
- Pneumococcal Infectious Disease
- Being tested
- Sinovac PCV24, Prevnar®
- Keywords
- PCV24, Phase 2
- 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 PCV24Biological
Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.
Prevnar®Biological
Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.
| Study group | Role | What they receive |
|---|---|---|
| Sinovac PCV24 | Experimental | Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules. Receives: Biological: Sinovac PCV24 |
| Prevnar® | Active comparator | Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules. Receives: Biological: Prevnar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
Measured: 30 days after primary vaccination
Incidence of adverse reactions
Measured: 0-30 days after vaccination
Secondary outcomes (4)
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Measured: 30 days after the 2nd dose of the primary vaccination (2-month-olds), 30 days after primary vaccination (all participants)
OPA antibody levels for each pneumococcal serotype
Measured: 30 days after vaccination
Incidence of adverse reactions
Measured: 0-7 days after vaccination
Incidence of serious adverse events (SAE)
Measured: from vaccination to 6 months after final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start25 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2027 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300644
- Sponsor's protocol ID
- PRO-PCV24-1005
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No