Safety Profile Following Td Vaccination in Indonesian Pre... | NCT03383653

Studies
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

NCT03383653

Sponsor

PT Bio Farma

Status

Completed

Last Update Posted

Mar 6, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Healthy
Pregnant

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

Mar 2018

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

Aug 29, 2017Actual

Primary Completion Date

Jan 15, 2018Actual

Completion Date

Jan 31, 2018Actual

First Submitted Date

Nov 1, 2017

First Submission Date that Met QC Criteria

Dec 19, 2017

First Posted Date

Dec 26, 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

Mar 4, 2018

Last Update Posted Date

Mar 6, 2018Actual

Name	Class
Indonesian Vaccine Safety Advisory Committee	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman

Detailed Description

Any local and systemic reaction after Td immunization in pregnant woman (as a routine immunization program)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

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:

Healthy Pregnant Woman aged 18-39 years old
27-36 weeks of pregnancy
Subject have been informed properly regarding the study and signed the informed consent form
Subject will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant Woman

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

200 pregnant woman, 18-39 years old From provincial health primary center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julitasari Sundoro, MD	Indonesian Vaccine Safety Advisory Commitee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jakarta Provincial Ministry of Health		Jakarta	Jakarta Province		Indonesia