Pneumococcal Infectious DiseasesPhase 3NCT07593924
Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)
A Phase 3 study testing Sinovac PCV13 and Prevenar 13™ in people with Pneumococcal Infectious Diseases, run by Sinovac Life Sciences Co., Ltd. at 1 site in Philippines.
Trial summary
A Phase III clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in infants aged approximately 2 months (42 to 89 days). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. Read more about this study
- Who is it for?
- Ages 42 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infectious Diseases
- What is being tested?
- Sinovac PCV13 and Prevenar 13™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 sitePhilippines
- Study dates
- May 2026to Jul 2027
- Phase
- Phase 3
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 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Health infants aged approximately 2 months (42 to 89 days)
- Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
- Be able to provide the vaccination records since birth.
- The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
Who cannot join
- Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation;
- Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
- Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old.
- History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component.
- History of any laboratory confirmed pneumococcal bacterial pneumonia or invasive pneumococcal diseases caused by S pneumoniae.
- Premature infants (born before week 37 of gestation).
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- Severe congenital malformations, developmental disorders, clinically significant genetic defects, malnutrition.
- Autoimmune diseases or immunodeficiency/immunosuppression.
- Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
- Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
- Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation.
- Received blood products before investigational vaccine inoculation, or plan to receive these treatments during study participation.
- Received other investigational drugs/vaccines before enrollment, or plan to receive investigational drugs/vaccines during study participation.
- Received live attenuated vaccines or nucleic-acid vaccines within 14 days before enrollment.
- Received subunit or inactivated vaccines within 7 days before enrollment.
- Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
- Axillary temperature ≥ 37.5°C before enrollment.
- Any other factors judged by the investigators as unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines1 site
Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences
Imus, Cavite
Edison R. Alberto, (046)471-0996/+639171490841, edisonalberto@rocketmail.com
About this study
Official title: A Phase III, Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Administered as a Series of 2 Infant Doses and 1 Toddler Dose in Healthy Infants
A Phase III clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in infants aged approximately 2 months (42 to 89 days).
The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind, active controlled phase III clinical trial.
Read the detailed description
A phase III 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 Philippines infants aged approximately 2 months (42 to 89 days).
The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar 13™ manufactured by Pfizer.
About 500 infants aged approximately 2 months (42 to 89 days) will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
- Conditions
- Pneumococcal Infectious Diseases
- Being tested
- Sinovac PCV13, Prevenar 13™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinovac PCV13Biological
One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
Prevenar 13™Biological
One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Sinovac PCV 13 | Experimental | 250 participants aged 2 months (42 to 89 days) will receive 3 doses of Sinovac PCV13 at approximately 2, 4 and 12-15 months of age.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 PCV13 |
| Prevenar 13™ | Active comparator | 250 participants aged 2 months (42 to 89 days) will receive 3 doses of Prevenar 13™ at approximately 2, 4 and 12-15 months of age.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: Prevenar 13™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) > -10% for each serotype at 30 days after dose 2.
Measured: 30 days after dose 2.
Geometric mean concentrations (GMCs) of serotype-specific IgG antibody.
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) > 0.5 for each serotype at 30 days after dose 2.
Measured: 30 days after dose 2
Secondary outcomes (19)
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) > -10% for each serotype at 30 days after dose 3.
Measured: 30 days after dose 3.
Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody.
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) > 0.5 for each serotype at 30 days after dose 3.
Measured: 30 days after dose 3.
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 2
Measured: 30 days after dose 2
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL .
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 3.
Measured: 30 days after dose 3
GMC fold increases (GMFRs) in IgG antibody concentrations.
GMC fold increases (GMFRs) in IgG antibody concentrations from before dose 3 to 30 days after dose 3.
Measured: From before dose 3 to 30 days after dose 3
Percentage of participants with serotype-specific opsonophagocytosis assay (OPA) antibody titers ≥1:8
Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 2.
Measured: 30 days after the dose 2.
Percentage of participants with serotype-specific OPA antibody titers ≥1:8.
Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 3.
Measured: 30 days after the dose 3.
Geometric mean titers (GMTs) of serotype-specific OPA antibody.
Geometric mean titers (GMTs) of serotype-specific OPA antibody 30 days after dose 2.
Measured: 30 days after dose 2.
GMTs of serotype-specific OPA antibody .
GMTs of serotype-specific OPA antibody at 30 days after dose 3.
Measured: 30 days after dose 3.
GMT fold rises (GMFRs) in OPA titers.
GMT fold rises (GMFRs) in OPA titers from before dose 3 to 30 days after dose 3.
Measured: From before dose 3 to 30 days after dose 3.
Incidence of adverse reactions
Incidence of adverse reactions within 30 days after each dose.
Measured: 0-30 days after each dose.
Incidence of adverse reactions
Incidence of adverse reactions within 7 days after each dose
Measured: 0-7 days after each dose
Incidence of serious adverse events(SAEs)
Incidence of SAEs from dose 1 to 30 days after dose 3
Measured: From dose 1 to 30 days after dose 3
Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL
Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib
Measured: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL
Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib
Measured: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration
Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration ≥ the observed anti-pertussis antibody concentration achieved by 95% of Prevenar 13™ recipients at 30 days after dose 3 of DTwP-HepB-Hib
Measured: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-Haemophilus influenzae type b (PRP) IgG concentration≥0.15 µg/mL
Percentage of infants with anti-Haemophilus influenzae type b (PRP) IgG concentration≥0.15 µg/mL at 30 days after dose 3 of DTwP-HepB-Hib
Measured: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL
Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL at 30 days after dose 3 of DTwP-HepB-Hib
Measured: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8
Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8 measured at 30 days after dose 3 of IPV
Measured: 30 days after dose 3 of IPV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startMay 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 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 DiseasesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edison Alberto, Principal investigator, Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593924
- Sponsor's protocol ID
- PRO-PCV13-3003
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No