Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV
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|ClinicalTrials.gov Identifier: NCT03310073|
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: bOPV Biological: Pentabio Biological: IPV||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety Profile of Primary Dose of Bivalent OPV (bOPV Bio Farma) Given Simultaneously With Pentabio® And Inactivated Poliovirus Vaccine (IPV) at the 4th Visit in Indonesian Infants|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: bOPV (bivalent OPV Bio Farma)
bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally.
The subject received bOPV, Pentabio and IPV according to the study schedule.
Batch Number: 2042015
Other Name: bivalent Oral Polio Vaccine
Batch number: 5050115 The vaccine shall be given intramuscularly.
Other Name: DTP-HB-Hib Vaccine
The vaccine shall be given intramuscularly.
- Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3 [ Time Frame: 30 days after the last vaccination ]Evaluate protectivity
- Percentage of infants with increasing antibody titer >= 4 times [ Time Frame: 30 days after the last vaccination ]Serological response after four doses of bOPV with 1 dose of IPV
- Percentage of infants with transition of seronegative to seropositive [ Time Frame: 30 days after the last vaccination ]Serological response after four doses of bOPV with 1 dose of IPV
- Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV [ Time Frame: 30 days after the last vaccination ]Geometric Mean Titer (GMT) 30 days after the last vaccination
- Number and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabio and 1 dose of IPV [ Time Frame: first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination. ]Assess the safety of bOPV
- Number of serious adverse events (SAE) which occured during the study [ Time Frame: 30 days after the last vaccination ]Assess the safety of bOPV
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310073
|Hasan Sadikin Hospital|
|Bandung, West Java, Indonesia, 40161|
|Principal Investigator:||Kusnandi Rusmil||Hasan Sadikin General Hospital|