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

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
RSHS/UNPAD
No Registry
INA-C273S0L
Tanggal Input Registry : 12-07-2018

04-07-2016
To evaluate protectivity following four doses of bOPV which given Simultaneously with Pentabio® and 1 dose of IPV at the 4th visit - Seroprotection rates were 100%, 91.6%, and 99.3%for P1, P2, and P3, respectively
1. Occurrence and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabioand 1 dose of IPV within first 30 minutes, H1-H3 after vaccination. - There is systemic event (irritable) within 30 minutes in 4 subjects, 3 subjects, and 1 subject after 2nd, 3rd, and 4th immunization, respectively. - Most solicited systemic reactions (irritable and fever) occurred within 3 days of vaccine administration and resolved within 3 days after any in¬jections, and the intensity were grade 1. 2. Any serious adverse event which occurred during the study. - Seven subjects were hospitalized during the study, all events were coincidence and not related to vaccine
 
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
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
Observasional
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.
150
 

Inclusion Criteria:

• Healthy, full term, newborns infants. • Newborns residing within a relatively short and easily accessible distance ( 2.5 kg) • Healthy newborns, with no history of asphyxia or meconium aspiration. • Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. • Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial. • Mother at least elementary school graduate

Exclusion Criteria:

• Child concomitantly enrolled or scheduled to be enrolled in another trial • Known history of congenital or acquired immunodeficiency (including HIV infection) • Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature  37.5C ) • Newborns requiring hospitalization at birth. • Infant immunized with non-scheduled bOPV or IPV during trial
 
328/UN6.C1.3.2/KEPK/PN/2016
NA
PN.01.06.313.3.06.16.3095
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Prof. Dr. Kusnandi Rusmil, dr.,Sp.A(K).,MM