Evaluating a new pneumococcal vaccine in infants
Official title: A Multi-center, Randomized, Blinded, Active-controlled, Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered with Hexavalent Vaccine At 2, 4 and 12-15 Months of Age to Healthy Infants in Indonesia
Run by Beijing Minhai Biotechnology Co., Ltd · NCT06608199 · Data updated 2026-11-12
This study is testing a new pneumococcal vaccine for infants to see if it is safe and works as well as an existing vaccine when given with other routine shots.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 6 Weeks to 8 Weeks |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Beijing Minhai Biotechnology Co., Ltd Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 3 sites (Denpasar, Bali and 2 other locations) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | June 1, 2025 |
| Study ends | October 1, 2026 |
| Registry record updated | March 24, 2025 |
| Trial ID | NCT06608199 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy infants aged 6-8 weeks who meet specific health criteria.
✕Probably not a fit
Patients who are not healthy infants or those outside the age range of 6-8 weeks will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) compared to Pfizer's PCV13 vaccine when administered alongside Hexavalent Vaccines to healthy infants in Indonesia. Approximately 500 infants aged 6-8 weeks will be enrolled and randomly assigned to receive either the study vaccine or the control vaccine at specified intervals. The study will measure immune responses one month after the booster dose and monitor safety outcomes throughout the trial.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective pneumococcal vaccine option for infants.
How similar studies have gone: Other studies have shown success with similar pneumococcal vaccine approaches, indicating a promising avenue for this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy infants based on medical history and clinical assessment. 2. Infants age of 6-8 weeks at enrolment. Infants will be eligible since the day they reach 6 weeks of age and until 8 weeks of age included. 3. \*Body weight at enrollment ≥3.0 kg (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.). 4. \*On the day of vaccination and within 3 days prior to 1st dose of vaccination, axillary temperatures \<37.5°C/99.1°F (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.). 5. Infant's parent(s) or legal guardian must be able and willing to provide voluntary written/thumb-printed informed consent for the infant to participate in the study. 6. Infant's parent(s) or legal guardian must be willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. 7. The infant's mother must provide related medical certificate(s) for the negative results for HIV, HBV and syphilis infection within 1 year prior to screening. 8. Infant's parent(s) or legal guardian must have a readily identifiable place of residence in the study area, be available for the duration of trial participation, and have a means of telephone contact. Note: For items with an asterisk (\*), If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met. Exclusion Criteria: 1. Use of any investigational product other than that used in the study prior to randomization or planned use of such a product during the period of study participation. 2. History of S. pneumoniae infection as confirmed by laboratory testing if available. 3. The infant who are children in care, preterm and low-birth-weight (Preterm infants have a gestational age below 37 weeks at birth and low-birth-weight infants have a birth weight below 2.5 kg). 4. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine. And/or all components of the hexavalent vaccine. 5. History of anaphylactic shock. 6. Any abnormal vital sign as judged by the investigator. 7. \*Participant experiences acute diseases or acute exacerbation of chronic diseases or uses antipyretic, analgesic and anti-allergic drugs (such as paracetamol, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days before vaccination. 8. \*History of administration of attenuated vaccines within 14 days (\<14 days) and inactivated vaccines within 7 days (\<7 days) prior to the 1st dose of investigational vaccine (If the participant\[s\] does not meet the criteria, the visit may be rescheduled when the criteria are met). 9. Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given before 2 months of life according to the national recommendations. 10. History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis. 11. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥10 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids within indicated dosage are permitted. 12. \*Administration of immunoglobulins and/or any blood products or anticipation of such administration within 28 days before vaccination and during the study period. 13. History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factors deficiency, severe anemia at birth). 14. History of suspected primary immunodeficiency. 15. History of meningitis, seizures or any neurological disorder. 16. A family history of congenital or hereditary immunodeficiency. 17. The infant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the investigator, study site personnel. 18. Any medical or social condition that in the opinion of the investigator may compromise the well-being of the study participant, interfere with the study objectives, pose a risk to the study participant, or prevent the study participant from completing the study follow-up. Note: For items with an asterisk (\*), if the participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met.
Where it's running
-
Faculty of Medicine, padjadjaran University
Bandung, Bandung, Indonesia Recruiting -
Faculty of Medicine Udayana University
Denpasar, Bali, Indonesia Not yet recruiting -
Universitas Padjadjaran Bandung
Bandung, Bandung, Indonesia Not yet recruiting
Similar studies
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This study is testing how safe and effective meningococcal and pneumococcal vaccines are for adults with HIV who are on treatment.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.