Safety Profile Following Pentabio Vaccination in Indonesi... | NCT02093286

Studies
Safety Profile Following Pentabio Vaccination in Indonesian Infants

NCT02093286

Sponsor

PT Bio Farma

Status

Completed

Last Update Posted

Nov 6, 2017Actual

Enrollment

4,000Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

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

Dec 2014

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

May 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 19, 2014

First Submission Date that Met QC Criteria

Mar 19, 2014

First Posted Date

Mar 20, 2014Estimated

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 1, 2017

Last Update Posted Date

Nov 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To assess any serious systemic reaction within 30 minutes after Pentabio immunization

Detailed Description

Any local and systemic reaction after Pentabio immunization

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pentabio Vaccine		1 dose of Pentabio vaccine, 0.5 ml Will be given intramuscularly

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Any serious adverse event occurring from inclusion until 30 minutes after the injection	local and systemic reaction	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Percentage of local and systemic events occurring within 72 hours after each injection	any local and systemics events	72 hours
Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Immunization with Pentabio vaccine
Parents already understood the consequences to be involved in this study and having signed the informed consent form
Parents agree and willing to fill in the Diary Card, to record all the reactions after immunization

Exclusion Criteria:

Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

11 Months

Standard Ages

Child

Study Population

4000 infants, 2-11 months old From 4 provincial health primary center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julitasari Sundoro, MD	AEFI National Committee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West Java Provincial Ministry of Health		Bandung	West Java		Indonesia
West Nusa Tenggara Provincial Ministry of Health