Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Tahapan Penelitian : Complete
Sponsor:
PT Bio Farma
Mitra Pelaksana:
UNAIR/RS DR SOETOMO
No Registry
INA-BCER292
Tanggal Input Registry : 13-07-2018
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 04-09-2017 |
| Outcome Primer | • To assess serious immediate systemic events within the first 30 minutes after Measles-Rubella (MR) vaccine in infants and children. |
| Outcome Skunder | • To assess local reaction after Measles-Rubella (MR) vaccine in infants and children. • To assess systemic event after Measles-Rubella (MR) vaccine in infants and children. • To evaluate the protectivity against Measles and Rubella after 1 dose of MR vaccine in in infants and children. • To describe antibody response to Measles and Rubella after 1 dose of MR vaccine in infants and chidren. |
| Descriptive Information | |
| Judul Penelitian Popular | Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children |
| Judul Penelitian Ilmiah | Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children |
| Jenis Penelitian | Observational |
| Intervensi | 1 dose Measles Rubella (MR) vaccine |
| Jumlah Subyek Penelitian | 200 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: • To assess serious immediate systemic events within the first 30 minutes after Measles-Rubella (MR) vaccine in infants and children.Exclusion Criteria: • To assess local reaction after Measles-Rubella (MR) vaccine in infants and children. • To assess systemic event after Measles-Rubella (MR) vaccine in infants and children. • To evaluate the protectivity against Measles and Rubella after 1 dose of MR vaccine in in infants and children. • To describe antibody response to Measles and Rubella after 1 dose of MR vaccine in infants and chidren. |
| Administrative Information | |
| Nomor Persetujuan Etik | No. 239/EC/KEPK/FKUA/2017 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | PMS MR 0417 |
| Contact Person | Dr. dr. Dominicus Husada, SpA(K) |