Pneumococcal Infectious DiseasePhase 1NCT06800261
Clinical Trial of PCV24 in Infants Aged 2-23 Months
A Phase 1 study testing Sinovac PCV24 and Prevnar® in people with Pneumococcal Infectious Disease, run by Sinovac Life Sciences Co., Ltd. at 2 sites in China.
Trial summary
A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months. 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 23 monthsHealthy 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
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 8 May 2025to Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 23 months
- 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;
- Participants' guardian provides legal identity document and participants' vaccination record;
- Participants' 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);
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
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- 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 platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture).
- Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but 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.
- Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Shandong Provincial Center for Disease Control and Prevention
Jinan, Shandong, 250014
Qing Xu, 18853165516, xqepi@163.com
- Recruiting
Shanxian Center for Disease Control and Prevention
Shancheng, Shandong, 250014
Shanxian Center for Disease Control and Prevention
About this study
Official title: A Randomized, Double-blind, Positive Controlled Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 (Minimum 42 Days)-23 Months
A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months.
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 Ib clinical trial.
Read the detailed description
A phase 1b 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 Chinese pediatric population aged 2 months (minimum 42 days)-23 months. 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 180 participants aged 2 months (minimum 42 days)-23 months will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
- Conditions
- Pneumococcal Infectious Disease
- Being tested
- Sinovac PCV24, Prevnar®
- 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 |
|---|---|---|
| Experimental: Sinovac PCV24 | Experimental | Participants aged 2 months (minimum 42 days)-23 months will receive Sinovac PCV24 according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months. Receives: Biological: Sinovac PCV24 |
| Active Comparator: Prevnar® | Active comparator | Participants aged 2 months (minimum 42 days)-23 months will receive Prevnar 13® according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months. Receives: Biological: Prevnar® |
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 (6)
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: from vaccination to 6 months after final dose
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC 30 days after primary vaccination
Measured: 30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
IgG GMI 30 days after primary vaccination
Measured: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Measured: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Measured: 30 days after primary vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start8 May 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Xu, Principal investigator, Shandong Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800261
- Sponsor's protocol ID
- PRO-PCV24-1003
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Positive Controlled Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 (Minimum 42 Days)-23 Months
- ClinicalTrials.gov ID
- NCT06800261
- Acronym / sponsor ID
- PRO-PCV24-1003
- Conditions
- Pneumococcal Infectious Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months.
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 Ib clinical trial.
Detailed description
A phase 1b 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 Chinese pediatric population aged 2 months (minimum 42 days)-23 months. 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 180 participants aged 2 months (minimum 42 days)-23 months will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Sinovac PCV24 | Experimental | Biological: Sinovac PCV24Participants aged 2 months (minimum 42 days)-23 months will receive Sinovac PCV24 according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months. |
| Active Comparator: Prevnar® | Active comparator | Biological: Prevnar®Participants aged 2 months (minimum 42 days)-23 months will receive Prevnar 13® according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months. |
Who may qualify
- Ages
- 42 days to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;
- Participants' guardian provides legal identity document and participants' vaccination record;
- Participants' guardian understands and voluntarily signs the informed consent form;
- Follow all study procedures and stay in contact during the study.
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinovac PCV24Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules. | Biological | Experimental: Sinovac PCV24 |
| Prevnar®Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules. | Biological | Active Comparator: Prevnar® |
Primary outcome
Incidence of adverse reactions
Time frame: 0-30 days after vaccination
Incidence of adverse reactions within 30 days after vaccination
6 secondary outcomes
Incidence of adverse reactions
Time frame: 0-7 days after vaccination
Incidence of serious adverse events (SAE)
Time frame: from vaccination to 6 months after final dose
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Time frame: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Time frame: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Time frame: 30 days after primary vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qing Xu principal investigator
Shandong Provincial Center for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sinovac PCV24 and Prevnar® in people with Pneumococcal Infectious Disease, run by Sinovac Life Sciences Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing Xu (18853165516, xqepi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: 0-30 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.