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Pneumococcal Infectious DiseasePhase 1NCT06183216

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

A Phase 1 study testing Sinovac PCV13 and PREVNAR 13 in people with Pneumococcal Infectious Disease, run by Sinovac Research and Development 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 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. Read more about this study

Who is it for?
Ages 6 weeks to 5 yearsHealthy volunteers can take part
Conditions the study is for
Pneumococcal Infectious Disease
What is being tested?
Sinovac PCV13 and PREVNAR 13
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
4 Jan 2024to 26 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 6 weeks to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • Received any pneumococcal vaccine prior to enrollment.
  • History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae.
  • 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.
  • History of dystocia, asphyxia rescue, nervous system damage at birth (only applicable to infants aged 2 months (42-89 days))
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, asthma etc.
  • Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/ immunosuppression (such as HIV, organ transplantation)
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  • Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases, malignant tumors.
  • Family history of mental illness, severe neurological disease (epilepsy or convulsions) or mental illness.
  • History of thyroidectomy, asplenia, functional asplenia; and asplenia or splenectomy resulting from any condition.
  • 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.
  • 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
  • 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).
  • Receipt of other investigational drugs in the past 60 days or have the plan to participate in other clinical trials during this study.
  • Receipt of attenuated live vaccines in the past 14 days.
  • Receipt of inactivated or subunit vaccines in the past 7 days.
  • Acute diseases or acute exacerbation of chronic diseases in the past 7 days.
  • Axillary temperature ≥37.3 °C.
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Binchuan County Center for Diseases Control and Prevention

    Dali, Yunnan, 671600

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Sinovac PCV13, PREVNAR 13
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 PCV13Biological

    0.5 mL dose of Sinovac PCV13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

  • PREVNAR 13Biological

    0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

Study groups in NCT06183216
Study groupRoleWhat they receive
Infants aged 2 months in experimental groupExperimental35 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.
Receives: Biological: Sinovac PCV13
Infants aged 2 months in control groupActive comparator35 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.
Receives: Biological: PREVNAR 13
Children aged 2-5 years in experimental groupExperimental35 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.
Receives: Biological: Sinovac PCV13
Children aged 2-5 years in control groupActive comparator35 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.
Receives: Biological: PREVNAR 13

What is being measured

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

  1. Incidence of adverse reactions

    Incidence of adverse reactions within 30 days after each dose

    Measured: 0-30 days after each dose

Secondary outcomes (10)

  1. Incidence of adverse reactions

    Incidence of adverse reactions within 7 days after each dose

    Measured: 0-7 days after each dose

  2. Incidence of SAE

    Incidence of SAE during the period of safety monitoring

    Measured: 6 months after vaccination for children aged 2-5 years; 1 month after completion of booster vaccination for infants aged 2 months.

  3. IgG concentration ≥0.35μg/mL for infants aged 2 months

    The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after primary/booster immunization.

    Measured: 30 days after primary/booster immunization

  4. IgG concentration ≥1.0μg/mL for infants aged 2 months

    The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after primary/booster immunization.

    Measured: 30 days after primary/booster immunization

  5. GMCs for infants aged 2 months

    GMCs for each serotype 30 days after primary/booster immunization

    Measured: 30 days after primary/booster immunization

  6. GMIs for infants aged 2 months

    GMIs (GMC increase folds) for each serotype 30 days after primary/booster immunization

    Measured: 30 days after primary/booster immunization

  7. IgG concentration ≥0.35μg/mL for children aged 2-5 years

    The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after vaccination.

    Measured: 30 days after vaccination

  8. IgG concentration ≥1.0μg/mL for children aged 2-5 years

    The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after vaccination.

    Measured: 30 days after vaccination

  9. GMCs for children aged 2-5 years

    GMCs for each serotype 30 days after vaccination

    Measured: 30 days after vaccination

  10. GMIs for children aged 2-5 years

    GMIs (GMC increase folds) for each serotype 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.

  1. First posted27 Dec 2023
  2. Study start4 Jan 2024
  3. Primary completion26 Mar 2025
  4. Study completion26 Mar 2025

Resources

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
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06183216
Sponsor's protocol ID
PRO-PCV-1002
Status last verified
Jan 2026
First submitted
13 Dec 2023
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sinovac PCV13 and PREVNAR 13 in people with Pneumococcal Infectious Disease, run by Sinovac Research and Development Co., Ltd. at 1 site 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: finished, 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 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of adverse reactions (time frame: 0-30 days after each dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06183216.

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.

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