Minhai-PCV13 Study
| 1. Background | |
|---|---|
| Registration Number | INA-BWTGS8D |
| Date of registry approval | 29-10-2024 |
| Registration Date | 14-10-2024 |
| Secondary identifiers | Yes |
| Name of issuing authority (for example protocol number, other registries, etc) | Protocol Number: S20210036-5 |
| Secondary identifier number | clinicaltrials.gov Identifier: NCT06608199 |
| Scientific study 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 Health Infants in Indonesia |
| Public (popular study title) | Minhai-PCV13 Study |
| 2. Sponsor and Funding | |
| Primary Sponsor | Beijing Minhai Biotechnology Co., Ltd. |
| Source(s) of monetary or material support | Beijing Minhai Biotechnology Co., Ltd. |
| Other partners | 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) |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | DR. Dr. I Gusti Ayu Trisna Windiani, Sp.A(K) (Denpasar) and Dr. Eddy Fadlyana, dr., Sp.A(K)., MKes. (Bandung) |
| City | Denpasar and Bandung |
| Country | Indonesia |
| Principal investigator's affiliation | DR. Dr. I Gusti Ayu Trisna Windiani, Sp.A(K). Program Studi Magister Ilmu Kesehatan Masyarakat Fakultas Kedokteran Universitas Udayana Dr. Eddy Fadlyana, dr., Sp.A(K)., MKes. Jl. Professor Eijkman No.38, Bandung 40161 Departemen Ilmu Kesehatan Anak Fakultas Kedokteran Universitas Padjadjaran / RS. Hasan Sadikin |
| Principal Investigator's email address | DR. Dr. I Gusti Ayu Trisna Windiani, Sp.A(K).: trisnawindianidr@yahoo.co.id ; Dr. Eddy Fadlyana, dr., Sp.A(K)., MKes.: edfadlyana@yahoo.com |
| Public Queries | |
| Contact person name for public queries | Dr. Viryandi |
| Address for public queries | PT Jakarta Biopharmaceutical Industry (JBio) Jl. Kampung Bunian RT 02 RW 03, Sukatani, Cikande, Serang, Banten 42186 |
| City | Serang |
| Country | Indonesia |
| ZIP | 42186 |
| Affiliation for public queries | PT Jakarta Biopharmaceutical Industry (JBio) |
| Email address for public queries | viryandi@jbio.co.id ; christian.wijaya@jbio.co.id ; mahendra.suhardono@jbio.co.i |
| Phone number for public queries | +62 821-2138-3892; +62 812-9440-2008 |
| Scientific Queries | |
| Name of Contact for scientific queries | Dr. Dr. I Gusti Ayu Trisna Windiani, Sp.A(K). and Dr. Eddy Fadlyana, dr., Sp.A(K)., MKes. |
| Address for scientific queries | DR. Dr. I Gusti Ayu Trisna Windiani, Sp.A(K). Jl. Diponegoro, Dauh Puri Klod, Denpasar 80113 Program Studi Magister Ilmu Kesehatan Masyarakat Fakultas Kedokteran Universitas Udayana Dr. Eddy Fadlyana, dr., Sp.A(K)., MKes. Jl. Professor Eijkman No.38, Bandung 40161 Departemen Ilmu Kesehatan Anak Fakultas Kedokteran Universitas Padjadjaran / RS. Hasan Sadikin |
| City | Denpasar and Bandung |
| Country | Indonesia |
| ZIP | NA |
| Affiliation of scientific queries contact | DR. Dr. I Gusti Ayu Trisna Windiani, Sp.A(K). Jl. Diponegoro, Dauh Puri Klod, Denpasar 80113 Program Studi Magister Ilmu Kesehatan Masyarakat Fakultas Kedokteran Universitas Udayana Dr. Eddy Fadlyana, dr., Sp.A(K)., MKes. Jl. Professor Eijkman No.38, Bandung 40161 Departemen Ilmu Kesehatan Anak Fakultas Kedokteran Universitas Padjadjaran / RS. Hasan Sadikin |
| Email address for scientific queries | DR. Dr. I Gusti Ayu Trisna Windiani, Sp.A(K).: trisnawindianidr@yahoo.co.id ; Dr. Eddy Fadlyana, dr., Sp.A(K)., MKes.: edfadlyana@yahoo.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | Denpasar: Ethical Clearance No. 1928/UN14.2.2.VII.14/LT/2024; Bandung: Ethical Approval No. 955/UN6.KEP/EC/2024 |
| Name of Ethics committee | Research Ethics Committee of the Faculty of Medicine, Udayana University - RSUP Prof. dr. I.G.N.G. Ngoerah and Research Ethics Committee Padjadjaran University– RSUP Dr. Hasan Sadikin |
| Date of Ethic approval | 22-08-2024 |
| Contact details of Ethic Committee (phone, email, and office) | Denpasar: Jl. P. Serangan, Denpasar, Bali 80114 Indonesia +62 361 244 364 mistik_fk@unud.ac.id Bandung: Jl. Prof. Eijkman No. 38, Bandung 40161 Indonesia +62 22 2038 697 kep@unpad.ac.id |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.06.32.321.10.2024.9045 dated 01 Oct 2024 |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | Denpasar: Program Studi Magister Ilmu Kesehatan Masyarakat FK-Universitas Udayana (2 satellite sites) - Puskesmas I Denpasar Selatan - Puskesmas II Denpasar Utara Bandung Departemen Ilmu Kesehatan Anak FK UNPAD-RSHS (3 satellite sites) - Puskesmas Garuda - Puskesmas Ciumbuleuit - Puskesmas Dago |
| Recruitment status | Recruit |
| Date of first enrollment | 01-11-2024 |
| Targeted Sample size | 00500 - |
| Number of enrolled participants | On going |
| 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) | Prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F |
| 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 | Active-controlled, multicenter |
| Masking | Study Team |
| Study intervention (study arm) | 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 |
| Control intervention (control arm) | Control vaccine: Prevenar13® Manufactured by: Pfizer Ireland Pharmaceuticals 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 |
| Intervention assignment | Parallel |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 6 weeks at enrolment |
| Maximum age | 8 weeks at enrolment |
| 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 temperatures |
| 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-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 ( |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | Serotype-specific IgG responses 30 days after booster dose of the investigational vaccine |
| Metric/method of measurement | 1. Percentage of participants with serotype-specific IgG concentrations ≥ 0.35 μg/mL, measured 30 days after the booster dose of the investigational vaccine. 2. Geometric mean concentration (GMC) ratio of serotype-specific IgG responses 30 days after the booster dose of the investigational vaccine. |
| Timepoint(s) of measurement | 30 days after each booster dose |
| 9. Study Results | |
| Brief summary of study results | |
| Date of results summaries | |
| Participant flow | |
| Baseline characteristic | NA |
| 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)) | Undecided |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | NA |