PCV13-004
| 1. Background | |
|---|---|
| Registration Number | INA-7Z21AH4 |
| Date of registry approval | 14-11-2023 |
| Registration Date | 14-09-2023 |
| Secondary identifiers | Yes |
| Name of issuing authority (for example protocol number, other registries, etc) | PCV13-004 |
| Secondary identifier number | PCV13-004 |
| Scientific study title | 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 |
| Public (popular study title) | PCV13-004 |
| 2. Sponsor and Funding | |
| Primary Sponsor | Yuxi Walvax Biotechnology Co., Ltd No. 83 South Dongfeng Road, High & New Technology Industries Development Zone, Yuxi, Yunnan Province, China |
| Source(s) of monetary or material support | Yuxi Walvax Biotechnology Co., Ltd No. 83 South Dongfeng Road, High & New Technology Industries Development Zone, Yuxi, Yunnan Province, China |
| Other partners | 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. |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Dr.dr. Nastiti Kaswandari, Sp.A(K) (Jakarta) and Dr.dr.I Gusti Ayu Trisna Windiani, Sp.A(K) (Bali) |
| City | Jakarta and Bali |
| Country | IIndonesia |
| Principal investigator's affiliation | RSUPN Cipto Mangunkusumo Jakarta and RSUP Prof. I.G.N.G Ngoerah Denpasar |
| Principal Investigator's email address | Dr.dr. Nastiti Kaswandari, Sp.A(K) (+62 815-9416-858) and Dr.dr.I Gusti Ayu Trisna Windiani, Sp.A(K) (trisnawindianidr@yahoo.co.id) |
| Public Queries | |
| Contact person name for public queries | Puspa Restu Sayekti |
| Address for public queries | PT Etana Biotechnologies Indonesia, Kawasan Industri Pulo Gadung, Jl. Rawa Gelam V Blok L Kav. 11-13, Cakung, Jakarta Timur, DKI Jakarta |
| City | Jakarta |
| Country | Indonesia |
| ZIP | 13930 |
| Affiliation for public queries | PT Etana Biotechnologies Indonesia |
| Email address for public queries | puspa.sayekti@id.etanabiotech.com |
| Phone number for public queries | 085716183552 |
| Scientific Queries | |
| Name of Contact for scientific queries | Lei Shi |
| Address for scientific queries | No. 83 South Dongfeng Road, High & New Technology Industries Development Zone, Yuxi, Yunnan Province, China |
| City | Yuxi |
| Country | China |
| ZIP | N/A |
| Affiliation of scientific queries contact | Yuxi Walvax Biotechnology Co., Ltd |
| Email address for scientific queries | lei.shi@walvax.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | No.KET-1028/UN2.F1/ETIK/PPM.00.02/2023 (Jakarta) and No.1286/UN14.2.2.VII.14/LT/2023 (Bali) |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan FK Universitas Indonesia and Komisi Etik Penelitian Fakultas KedoKeran Universitas Udayana |
| Date of Ethic approval | 31-07-2023 |
| Contact details of Ethic Committee (phone, email, and office) | No.KET-1028/UN2.F1/ETIK/PPM.00.02/2023 July 31st, 2023, from Research Ethic Committee Faculty of Medicine Indonesia University – RSUPN Dr. Cipto Mangunkusumo. No.1286/UN14.2.2.VII.14/LT/2023 May 15th, 2023, and No. 1674/UN14.2.2.V.14/2023 July 4th, 2023, from Ethic Committee Faculty of Medicine Udayana University. |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.06.1.3.09.23.35 |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | 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. |
| Recruitment status | Complete |
| Date of first enrollment | 01-11-2023 |
| Targeted Sample size | 00600 - |
| Number of enrolled participants | Not yet enrolling |
| Date of study completion (last participant, last visit) | |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Male and female PCV-naïve infants residing in Indonesia who are 6-8 weeks of age at enrollment. |
| Purpose of the study | Prevention |
| Study type | Interventional |
| Interventional Study category | Clinical trial |
| Study phase | Phase 3 |
| Method of allocation | Randomized allocation |
| Description of the allocation concealment mechanism and sequence generation | Double Blinded, Randomized, Positive-Controlled Trial. |
| Masking | Double Blinded (All parties excluede the specific unblinded team such as vaccine administrator and vaccine packing crew) |
| Study intervention (study arm) | 13-valent Pneumococcal Conjugate Vaccine (PCV13-TT) to Healthy Infants |
| Control intervention (control arm) | Prevnar-13 for Healthy Infants |
| Intervention assignment | Other |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 6 weeks at enrolment |
| Maximum age | 8 weeks at enrolment |
| 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. |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | 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. |
| Metric/method of measurement | (1) serotype-specific % of infants with immunoglobulin G (IgG) response ≥0.35 μg/mL and (2) serotype-specific IgG geometric mean concentrations (GMCs) measured 1 month after the booster dose. |
| Timepoint(s) of measurement | Percentage of infants with serotype-specific IgG concentrations ≥0.35 µg/mL, measured 1 month after the booster dose and Serotype-specific IgG GMCs measured 1 month after the booster dose. |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | Safety, Immune Response to primary series, Functional antibody response, Immune persistence. |
| Metric/method of measurement (SO1) | Safety (1) To evaluate the safety and tolerability of PCV13-TT when co-administered with routine pediatric vaccines at 2, 4 and 12-15 months of age, after each dose, (2) To evaluate the long-term safety of PCV13-TT up to 6 months after the booster dose; Immune Response to primary series (1) To evaluate the immunogenicity of PCV13-TT 1 month after the 2nd dose; Functional antibody response (1) To evaluate the functional serotype-specific antibody responses induced by PCV13-TT, as measured by serotype-specific Opsonophagocytic Activity (OPA) before the 1st dose, 1 month after the 2nd dose, before the booster dose and 1 month after the booster dose, Immune persistence; To evaluate the persistence of immune responses induced by PCV13-TT at 12-15 months of age, before the booster dose. |
| Timepoint(s) of measurement (SO1) | Safety (1) Frequency and severity of solicited local and systemic adverse events (AEs) within 30 min and 7 days after each dose, (2) Frequency and severity of unsolicited AEs within 30 days after each dose, (3) Frequency of serious AEs (SAEs) from dose 1 until 6 months after booster dose; Immune Response to primary series (1) Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL measured 1 month after the 2nd dose, (2) Serotype-specific IgG GMCs easured 1 month after the 2nd dose; Functional antibody response (1) Percentage of infants with serotype-specific OPA titer ≥1:8 measured at baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose (2) Serotype-specific OPA geometric mean titers (GMTs) measured at baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose; Immune persistence (1) Percentage of infants with serotype-specific IgG concentrations ≥0.35 µg/mL measured at 12-15 months of age, before the booster dose, (2) Serotype-specific IgG GMCs measured at 12-15 months of age, before the booster dose. |
| 9. Study Results | |
| Brief summary of study results | |
| Date of results summaries | |
| Participant flow | |
| Baseline characteristic | Male and female PCV-naïve infants residing in Indonesia who are 6-8 weeks of age at
enrollment. |
| Adverse events | |
| Outcome measures | |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | Yes |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | All is captured in Clinical Trial Agreement with study sites, following PMK 85 as government suggestions. |
| Other important informations | The abovementioned information might be different/updated according to the study progress, which will be captured in study protocol amendments. |