Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measure antibody persistence prior to booster administration of Pentabio vaccine.
Number and percentage of children with anti diphtheria, titer and anti tetanus titer >= 0.01 IU/ml, anti HBs >=10mIU/ml, anti Hib >=0.15ug/ml prior to booster administration.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentavalen | Experimental | Pentabio Vaccine One dose corresponds to 0.5ml The vaccine shall be given intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentavalen | Biological | Batch 5010613 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Geomoteric mean titer prior to booster administration of Pentabio vaccine | The number and percentage of children with anti diphtheria titer and anti tetanus titer >=0.01 IU/ml anti HBs >=10 mIU/ml, anti Hib >=0.15 ug/ml prior to booster administration. | visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Protectivity of Pentabio vaccine 1 month after the booster dose | Serological response to diphtheria, tetanus, pertussis and Hib (Geometric Mean Titer) | 1 month |
| Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kusnandi Rusmil, MD | Department of Child Health, School of Medicine Padjadjaran University | Principal Investigator |
| Hartono Gunardi, MD | Department of Child Health, School of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jatinegara Primary Health Center | Jakarta | Jakarta Special Capital Region | Indonesia | |||
| Mampang Prapatan Primary Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29804542 | Derived | Gunardi H, Rusmil K, Fadlyana E, Soedjatmiko, Dhamayanti M, Sekartini R, Tarigan R, Satari HI, Medise BE, Sari RM, Bachtiar NS, Kartasasmita CB, Hadinegoro SRS. DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old. BMC Pediatr. 2018 May 28;18(1):177. doi: 10.1186/s12887-018-1143-6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Geometric mean titer to diphtheria, tetanus, pertussis, Hepatitis B and Hib before immunization and 1 month after immunization |
| 1 month |
| Seroconversion and seroprotection before and 1 month after the booster dose | The changes of serological response before and after booster dose | 1 month |
| Number of participants with adverse events | Local and systemic reaction within 28 days after immunization. | 1 month |
| Jakarta |
| Jakarta Special Capital Region |
| Indonesia |
| Tebet Primary Health Center | Jakarta | Jakarta Special Capital Region | Indonesia |
| Garuda Primary Health Center | Bandung | West Java | Indonesia |
| Ibrahim Adjie Primary Health Center | Bandung | West Java | Indonesia |
| Puter Primary Health Centre | Bandung | West Java | Indonesia |