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OpenTrials
Completed

NCT Number: NCT03383653

Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

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

Completed

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Key information

Conditions

Healthy Pregnant

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

Jakarta Provincial Ministry of Health

Jakarta, Jakarta Province, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

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: 72 hours - 28 days

    any local and systemics 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

Collaborators

  • Indonesian Vaccine Safety Advisory Committee

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2017
Registry last updated
Mar 6, 2018

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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