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OpenTrials
Completed

NCT Number: NCT02093286

Safety Profile Following Pentabio Vaccination in Indonesian Infants

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

Completed

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Key information

Conditions

Healthy

Age range

2 month–11 month

Sex eligibility

All sexes

Study type

Observational

Primary location

West Java Provincial Ministry of Health, Bandung, West Java, Indonesia

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About this study

Any local and systemic reaction after Pentabio immunization

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 30 minutes

    local and systemic reaction

Secondary outcomes

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

    Time frame: 72 hours

    any local and systemics events

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

    Time frame: 25 days

    any local and systemic events

  3. Percentage of serious adverse events within 28 days after injection

    Time frame: 28 days

    Any serious adverse events

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Official study title

Phase IV, Study of Safety Profile Following Pentabio Vaccination in Indonesian Infants

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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