The vaccine will be available in prefilled vials containing 10 doses. Each vial will be labelled with the study ID of the participant. Therefore, for participants randomized to arm A and arm C, there will be 3 vials per participant for the 3 doses of the bOPV vaccine to be given 28 weeks apart. Any remaining, non-used doses of vaccine in the vial will be discarded.

Each dose of vaccine is 1.5ml in volume. Each vial will be labelled with the study ID of the participant. One vial will be used per participant per study visit. OCV was studied in a double-blind, randomized, placebo-controlled trial in Kolkata, India. Participants were 1 year and above in age. In these studies, 100 children aged 1-17 were administered 2-doses of OCV or placebo separated by an interval of two weeks, with 80% of vaccinated showing over 4 fold rise in serum V. cholerae O1 antibody titers, showing that the 2-dose regimen was well-tolerated, safe and immunogenic

Our primary analysis will be to compare seroconversion (defined as a change of status from seronegative to seropositive titers, or a ≥4-fold rise in antibody titer) for OPV1 and OPV 3 antibodies between Arm A and Arm C, to determine whether seroconversion to bOPV when administered with Shanchol is non-inferior to seroconversion to bOPV when bOPV is administered alone.
Our second objective will be to compare vibriocidal antibody seroconversion (also, ≥4-fold rise in antibody titers) to Shanchol when co-administered with OPV or when Shanchol is administered alone, Arm B compared to Arm C

Vaccine Reaction

OPV is a mixture of live attenuated poliovirus strains of each of the three serotypes, selected by their ability to mimic the immune response following infection with wild polioviruses, but with a significantly reduced incidence of spreading to the central nervous system.

Oral Polio Vaccine

Bivalent, Killed, Whole Cell Oral Cholera Vaccine

Oral Cholera Vaccine

Hazaribagh Field Clinic

Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine

Study on the Immunogenicity of Oral Polio Vaccine (OPV) and Oral Cholera Vaccine (OCV) When Co-administered

Anti-poliovirus antibodies P1 and P3 microneutralization titer when OPV and OCV are administered separately, and when given together.

Vibriocidal antibody response to V. cholerae O1, serotype Ogawa and Inaba when OPV and OCV are administered separately, and when given together.

The number of adverse events and serious adverse events between OPV and OCV when given alone versus when given concomitantly.

International Centre for Diarrhoeal Disease Research, Bangladesh

Centers for Disease Control and Prevention

Stanford University

We propose to conduct an open-label, randomized controlled study in Dhaka, Bangladesh, among healthy children aged 1 - 3 years old who have received either no dose or one dose of OPV and has not received any dose of IPV or OCV at any time before enrolment based upon immunization card record or history from parents after full informed consent. Participants will be randomized to one of three groups ; (i) OPV only, (ii) OCV only, or (iii) co-administered OPV and OCV

Laboratory staff will remain blinded throughout the study

We randomly allocated patients to treatment with IVIG or placebo. Children received either saline or intravenous immunoglobulin (IVIG) [ImmunoRel™ (batch 20081217)] at a dose of 400mg/kg/day for 5 days or an equivalent volume of 0.9% normal saline given intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute. All investigators, care providers and participants were blinded of the study drug. A second sealed envelope was kept with the patient's notes in case a physician urgently needed to know which drug a patient had received.

Japanese Encephalitis

IVIG group received 400mg/kg/day intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute for 5 days or appearance of side effect or adverse events.
Placebo group received 0.9% saline intravenous at similar rate.

Intravenous immunoglobulin [ImmunoRel™ (batch 20081217)]

Kanti Children's Hospital

BP Koirala Institute of Health Sciences

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

A Randomized Double Blind Placebo Controlled Trial to Assess the Safety and Efficacy of Intravenous Immunoglobulin (IVIG) in Children With Japanese Encephalitis in Nepal

Patients will be monitored for side effects such as infusion site reaction, diarrhea, rise in blood pressure (in mm Hg) and change in urinary output (in ml/Kg/hour) every 12 hours from first day of commencing treatment until until death or discharge. Patient on average are administered the study drug on the first day of admission. The study drug is administered daily for 5 days. Patients are discharged on an average on eighth day (192 hours) of hospital admission.

At the time of discharge(expected average of eighth day of admission) or death: Time to death, to recover from coma, to sit independently, to stand independently, to walk at least 5m independently, and to leave hospital.
At 6 months after discharge: history of further seizures, behavioral changes, evidence of recovery of neurological sequelae such as assessment of ability to sit independently, to stand independently, to walk at least 5 meters independently.

Pre-treatment was immediately prior to the first dose of study drug on the first day, mid-treatment was immediately prior to the 4th dose and post-treatment was 1hour after administering the fifth dose of the study drug.

poliomyelitis/تهوع

Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

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