Immunogenicity and Safety Profile of Primary Dose of bOPV... | NCT03310073

Studies
Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV

NCT03310073

Sponsor

PT Bio Farma

Status

Completed

Last Update Posted

Nov 8, 2017Actual

Enrollment

143Actual

Phase

Phase 4

Conditions

Healthy

Interventions

bOPV
Pentabio
IPV

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Apr 5, 2017

First Submission Date that Met QC Criteria

Oct 10, 2017

First Posted Date

Oct 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit

Detailed Description

To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bOPV (bivalent OPV Bio Farma)	Experimental	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.	Biological: bOPV Biological: Pentabio Biological: IPV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bOPV	Biological	Batch Number: 2042015	bOPV (bivalent OPV Bio Farma)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3	Evaluate protectivity	30 days after the last vaccination

Secondary Outcomes

Measure	Description	Time Frame
Percentage of infants with increasing antibody titer >= 4 times	Serological response after four doses of bOPV with 1 dose of IPV	30 days after the last vaccination
Percentage of infants with transition of seronegative to seropositive

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, full term, newborns infants.
Newborns residing within a relatively short and easily accessible distance (<30 km) from the study clinic(s) and not planning to travel away during the entire study period.
Infant born after 37 weeks of pregnancy
Infant weighing 2.5 kg or more at birth (Birth weight > 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

1 Day

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided