Actively Recruiting
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine
Led by Beijing Minhai Biotechnology Co., Ltd · Updated on 2025-03-24
500
Participants Needed
3
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) when co-administered with Hexavalent Vaccines at 2,4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-DT/TT (Pneuminvac) as compared to PCV13(Prevenar 13) one month after the booster dose, and evaluate the safety of PCV13 co-administrated with Hexavalent Vaccine(Hexaxim).
CONDITIONS
Official Title
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants based on medical history and clinical assessment
- Age between 6 and 8 weeks at enrollment
- Body weight of at least 3.0 kg at enrollment
- Axillary temperature below 37.5°C (99.1°F) on vaccination day and within 3 days prior to first dose
- Parent or legal guardian able and willing to provide written or thumb-printed informed consent
- Parent or legal guardian willing and able to comply with study visits, vaccination plan, laboratory tests, and procedures
- Infant's mother must provide medical certificates showing negative results for HIV, HBV, and syphilis within 1 year prior to screening
- Parent or legal guardian must have a fixed residence in the study area, be available during the trial, and have telephone contact
You will not qualify if you...
- Use of any investigational products other than the study vaccines before or during participation
- History of Streptococcus pneumoniae infection confirmed by lab tests if available
- Preterm infants (born before 37 weeks) or low-birth-weight infants (under 2.5 kg at birth)
- History of allergic disease or serious reaction to prior vaccinations or known allergy to vaccine components
- History of anaphylactic shock
- Any abnormal vital signs as judged by the investigator
- Acute illness or flare-up of chronic disease or use of certain medications within 3 days before vaccination
- Attenuated vaccines within 14 days or inactivated vaccines within 7 days before first vaccine dose (may reschedule if criteria not met)
- Previous vaccination against specified diseases except for first dose given before 2 months as per national recommendations
- History of or current diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, or Neisseria meningitidis
- Treatment with radiotherapy or immunosuppressive therapy including certain corticosteroids
- Administration or planned administration of immunoglobulins or blood products within 28 days before or during study
- Known blood disorders or coagulation issues causing anemia or bleeding
- History or suspicion of primary immunodeficiency
- History of meningitis, seizures, or neurological disorders
- Family history of congenital or hereditary immunodeficiency
- Direct descendant of study staff or sponsor employees
- Any medical or social condition that may affect participant safety or study completion
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Faculty of Medicine Udayana University
Denpasar, Bali, Indonesia, 80114
Not Yet Recruiting
2
Universitas Padjadjaran Bandung
Bandung, Bandung, Indonesia, 40161
Not Yet Recruiting
3
Faculty of Medicine, padjadjaran University
Bandung, Bandung, Indonesia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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