Pneumococcal Disease PreventionNCT07591181
A Study on the Immunization Schedule for the 13-Valent Pneumococcal Polysaccharide-Conjugate Vaccine in Healthy Infants
A study testing the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine in people with Pneumococcal Disease Prevention, run by Beijing Center for Disease Control and Prevention.
Trial summary
To compare the immunogenicity of the domestically produced PCV13 vaccine in healthy 2-month-old infants following administration via the 2+1 and 3+1 schedules, with the primary endpoint being the seroprevalence of specific IgG antibodies after completion of the vaccination series.To evaluate the safety of the 2+1… Read more about this study
- Who is it for?
- Ages 60 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease Prevention
- What is being tested?
- the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2026to 31 Dec 2027
- Phase
- Interventional
- 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 60 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1: Age at enrollment: 2 months (60-89 days)
- 2: A healthy male or female infant, born at term (≥37 weeks' gestation), with a birth weight of ≥2500 g
- 3: Parents/guardians must provide written informed consent, and participants must be capable of using a thermometer and a ruler and of completing the daily log card as instructed
- 4: Able to adhere to study protocols, including completing all visits and blood collections
Who cannot join
- received any pneumococcal vaccine before enrollment or schedule to receive a non-study pneumococcal vaccine during the study
- A history of culture-confirmed invasive disease caused by Streptococcus pneumoniae
- Known allergy to vaccine components, including excipients, diphtheria toxoid, tetanus toxoid, etc.
- Acute illness at enrollment or axillary temperature >37°C
- Immune deficiency, chronic illness, or use of immunosuppressive therapy
- Patients with thrombocytopenia, any coagulation disorder, or those receiving anticoagulant therapy
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- Participation in another clinical trial within the past 30 days or during this study
- Has received another live attenuated vaccine within the past 14 days, or another inactivated vaccine within the past 7 days
- Has received immunoglobulin within the past month
- Any circumstances that researchers believe may affect the evaluation of the study
About this study
To compare the immunogenicity of the domestically produced PCV13 vaccine in healthy 2-month-old infants following administration via the 2+1 and 3+1 schedules, with the primary endpoint being the seroprevalence of specific IgG antibodies after completion of the vaccination series.To evaluate the safety of the 2+1 schedule in infants and young children (incidence of adverse events and serious adverse events).
- Conditions
- Pneumococcal Disease Prevention
- Being tested
- the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccineDrug
2, 4, and 12 months vaccination schedule for arm A and 2, 4, 6 and 12 months vaccination schedule for arm B
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 2, 4, and 12 months vaccination schedule Receives: Drug: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine |
| B | Placebo comparator | 2, 4, 6 and 12 months vaccination schedule Receives: Drug: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity rate 30 days after the booster dose
Measured: 30 days after the booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start10 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal Disease PreventionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591181
- Sponsor's protocol ID
- BJCDCP-13
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Immunization Schedule for the 13-Valent Pneumococcal Polysaccharide-Conjugate Vaccine in Healthy Infants
- ClinicalTrials.gov ID
- NCT07591181
- Acronym / sponsor ID
- BJCDCP-13
- Conditions
- Pneumococcal Disease Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Beijing Center for Disease Control and PreventionOther government
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 May 2026 (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.
To compare the immunogenicity of the domestically produced PCV13 vaccine in healthy 2-month-old infants following administration via the 2+1 and 3+1 schedules, with the primary endpoint being the seroprevalence of specific IgG antibodies after completion of the vaccination series.To evaluate the safety of the 2+1 schedule in infants and young children (incidence of adverse events and serious adverse events).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine2, 4, and 12 months vaccination schedule |
| B | Placebo comparator | Drug: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine2, 4, 6 and 12 months vaccination schedule |
Who may qualify
- Ages
- 60 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1: Age at enrollment: 2 months (60-89 days)
- 2: A healthy male or female infant, born at term (≥37 weeks' gestation), with a birth weight of ≥2500 g
- 3: Parents/guardians must provide written informed consent, and participants must be capable of using a thermometer and a ruler and of completing the daily log card as instructed
- 4: Able to adhere to study protocols, including completing all visits and blood collections
Key exclusion criteria (10 listed)
- received any pneumococcal vaccine before enrollment or schedule to receive a non-study pneumococcal vaccine during the study
- A history of culture-confirmed invasive disease caused by Streptococcus pneumoniae
- Known allergy to vaccine components, including excipients, diphtheria toxoid, tetanus toxoid, etc.
- Acute illness at enrollment or axillary temperature >37°C
- Immune deficiency, chronic illness, or use of immunosuppressive therapy
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 |
|---|---|---|
| the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine2, 4, and 12 months vaccination schedule for arm A and 2, 4, 6 and 12 months vaccination schedule for arm B | Drug | A, B |
Primary outcome
Seropositivity rate 30 days after the booster dose
Time frame: 30 days after the booster dose
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 15 May 2026.
Related trials for Pneumococcal Disease Prevention
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Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer
Pneumococcal Polysaccharide Vaccine, Influenza Vaccines
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine in people with Pneumococcal Disease Prevention, run by Beijing Center for Disease Control and Prevention.
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 10 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: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seropositivity rate 30 days after the booster dose (time frame: 30 days after the booster dose). 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 15 May 2026.