Tahapan Penelitian : Initial
Yuxi Walvax Biotechnology Co., Ltd No. 83 South Dongfeng Road, High & New Technology Industries Development Zone, Yuxi, Yunnan Province, China
PT Etana Biotechnologies Indonesia as Sponsor Representative in Indonesia; PT Prodia Diacro Laboratories as CRO (Clinical Research Organization); RSUPN Cipto Mangunkusumo, RSUP Prof. I.G.N.G Ngoerah Denpasar, Puskesmas Kecamatan Matraman, Puskesmas Kecamatan Jatinegara, Puskesmas Kecamatan Cempaka Putih, Puskesmas Johar Baru, Puskesmas 1 Denpasar Selatan, Puskesmas 2 Denpasar Utara, dan Puskesmas 3 Denpasar Utara as study sites.
Tanggal Input Registry : 14-09-2023
|Tanggal Antisipasi Studi||01-11-2023|
|Outcome Primer||To demonstrate the non-inferiority of the serotype-specific immune responses elicited by PCV13-TT, for the 13 vaccine-serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), as compared to the serotype-specific immune responses elicited by PCV13.|
|Outcome Skunder||Safety, Immune Response to primary series, Functional antibody response, Immune persistence.|
|Judul Penelitian Popular||PCV13-004|
|Judul Penelitian Ilmiah||A phase 3, Randomized, Blinded, Active-controlled study to Evaluate the Immunogenicity and Safety of Walvax’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-TT) as Compared to Pfizer’s 13-valent Pneumococcal Conjugate Vaccine (PCV13) Co-administered with EPI Vaccines at 2, 4, and 12-15 Months of Age, to Healthy Infants in Indonesia|
|Intervensi||13-valent Pneumococcal Conjugate Vaccine (PCV13-TT) to Healthy Infants|
|Jumlah Subyek Penelitian||600|
Inclusion Criteria:Healthy infants based on medical history and clinical assessment, 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 ≥3.5 kg, 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 able to comprehend and comply with study requirements and procedures and must be willing and able to return or make themselves available for all scheduled follow-up visits, 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.
Exclusion Criteria:Use of any investigational medicinal 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, Participant has fever (axillary temperature ≥37.5℃) within 24 hours prior to the 1st dose of vaccination; (If the subject does not meet the criteria, the visit may be rescheduled when the criteria are met), 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 2 study vaccines. This includes all components of the EPI vaccines, History of anaphylactic shock, Any abnormal vital sign as judged by the investigator, Any moderate or severe acute illness, History of administration of a non-study vaccine within 30 days prior to administration of study vaccine, other than EPI vaccinations (Note: EPI vaccines other than that stipulated in the study must be given at least 14 days prior to the investigational vaccine), 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 ≥20 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 during the study period, History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, 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.
|Nomor Persetujuan Etik||No.KET-1028/UN2.F1/ETIK/PPM.00.02/2023 (Jakarta) and No.1286/UN14.2.2.VII.14/LT/2023 (Bali)|
|Nomor Persetujuan Material Transfer Agreement||Waiting for approval|
|Nomor Persetujuan Pelaksanaan Uji Klinik||PPUK/PPUB number|
|Other Study ID Numbers||PCV13-004|
|Contact Person||Puspa Restu Sayekti|