Minhai-PCV13 Study
Tahapan Penelitian : Recruit
Sponsor:
Beijing Minhai Biotechnology Co., Ltd.
Mitra Pelaksana:
Shanghai Stem Pharmaceutical Development Co., Ltd. (Central CRO)
PT Prodia Diacro Laboratories (Local CRO)
PT Jakarta Biopharmaceutical Industry (LLH)
National Institute for Food and Drug Control, China (Laboratory)
Prodia Clinical Laboratory (Laboratory)
Fakultas Kedokteran Universitas Udayana (Site)
Fakultas Kedokteran Universitas Padjadjaran (Site)
No Registry
INA-BWTGS8D
Tanggal Input Registry : 14-10-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-11-2024 |
| Outcome Primer | Serotype-specific IgG responses 30 days after booster dose of the investigational vaccine |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Minhai-PCV13 Study |
| Judul Penelitian Ilmiah | 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 Health Infants in Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Study vaccine: PCV13 (Pneuminvac) Provided by: Minhai Biotechnology Co., Ltd Dosage: 0.5 mL single-dose prefilled syringes Appearance: white suspension Dosage form: Injection Route of administration: intramuscular injection into the anterolateral aspect of the thigh |
| Jumlah Subyek Penelitian | 500 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Healthy infants based on medical history and clinical assessment. 2. Infants age of 6-8 weeks at enrollment. 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 temperaturesExclusion 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-birthweight (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 ( |
| Administrative Information | |
| Nomor Persetujuan Etik | Denpasar: Ethical Clearance No. 1928/UN14.2.2.VII.14/LT/2024; Bandung: Ethical Approval No. 955/UN6.KEP/EC/2024 |
| Nomor Persetujuan Material Transfer Agreement | Waiting for approval |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | clinicaltrials.gov Identifier: NCT06608199 |
| Contact Person | Dr. Viryandi |