NCT03383653

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

November 1, 2017

Last Update Submit

March 4, 2018

Conditions

HealthyPregnant

Keywords

Td VaccineSafetyPregnantPregnant Women

Outcome Measures

Primary Outcomes (1)

  • Any serious adverse event occurring from inclusion until 30 minutes after the injection

    local and systemic reaction

    30 minutes

Secondary Outcomes (3)

  • Percentage of local and systemic events occurring within 72 hours after each injection

    72 hours

  • Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.

    72 hours - 28 days

  • Percentage of serious adverse events within 28 days after injection

    28 days

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Woman
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Healthy Pregnant Woman aged 18-39 years old
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jakarta Provincial Ministry of Health

Jakarta, Jakarta Province, Indonesia

Location

Study Officials

  • Julitasari Sundoro, MD

    Indonesian Vaccine Safety Advisory Commitee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2017

First Posted

December 26, 2017

Study Start

August 29, 2017

Primary Completion

January 15, 2018

Study Completion

January 31, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

ID(1)