NCT02093286

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

March 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 6, 2017

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

March 19, 2014

Last Update Submit

November 1, 2017

Conditions

Healthy

Keywords

Pentabio VaccineSafetyInfantsBooster DoseDTwP/HepB/Hib

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.

    25 days

  • Percentage of serious adverse events within 28 days after injection

    28 days

Study Arms (1)

Pentabio Vaccine

1 dose of Pentabio vaccine, 0.5 ml Will be given intramuscularly

Eligibility Criteria

Age2 Months - 11 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

West Java Provincial Ministry of Health

Bandung, West Java, Indonesia

Location

West Nusa Tenggara Provincial Ministry of Health

Mataram, West Nusa Tenggara, Indonesia

Location

Bali Provincial Ministry of Health

Bali, Indonesia

Location

Yogyakarta Provincial Ministry of Health

Yogyakarta, Indonesia

Location

Study Officials

  • Julitasari Sundoro, MD

    AEFI National Committee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 20, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

November 6, 2017

Record last verified: 2014-12

Locations

ID(4)