Status:
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
Lead Sponsor:
Beijing Minhai Biotechnology Co., Ltd
Conditions:
Pneumococcal Vaccines
Pneumococcal Infections
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
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 Pneumoc...
Detailed Description
A total of approximately 500 infants 6-8 weeks of age (WOA) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 250 participants in each group.The study group wil...
Eligibility Criteria
Inclusion
- Healthy infants based on medical history and clinical assessment.
- 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.
- \*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.).
- \*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.).
- 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.
- 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.
- 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.
- 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
- 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.
- History of S. pneumoniae infection as confirmed by laboratory testing if available.
- 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).
- 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.
- History of anaphylactic shock.
- Any abnormal vital sign as judged by the investigator.
- \*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.
- \*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).
- 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.
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
- 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.
- \*Administration of immunoglobulins and/or any blood products or anticipation of such administration within 28 days before vaccination and during the study period.
- 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).
- History of suspected primary immunodeficiency.
- History of meningitis, seizures or any neurological disorder.
- A family history of congenital or hereditary immunodeficiency.
- The infant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the investigator, study site personnel.
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06608199
Start Date
November 1 2024
End Date
October 1 2026
Last Update
March 24 2025
Active Locations (3)
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1
Faculty of Medicine Udayana University
Denpasar, Bali, Indonesia, 80114
2
Universitas Padjadjaran Bandung
Bandung, Bandung, Indonesia, 40161
3
Faculty of Medicine, padjadjaran University
Bandung, Bandung, Indonesia