HealthyNCT03383653
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
An observational study of Healthy and Pregnant, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Aug 2017to 31 Jan 2018
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 200 pregnant woman, 18-39 years old From provincial health primary center
Who may be able to join
- 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
Who cannot join
- Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Jakarta Provincial Ministry of Health
Jakarta, Jakarta Province
About this study
To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman
Read the detailed description
Any local and systemic reaction after Td immunization in pregnant woman (as a routine immunization program)
- Keywords
- Td Vaccine, Safety, Pregnant, Pregnant Women
What is being measured
The primary outcome is the main question the study is designed to answer.
Any serious adverse event occurring from inclusion until 30 minutes after the injection
local and systemic reaction
Measured: 30 minutes
Secondary outcomes (3)
Percentage of local and systemic events occurring within 72 hours after each injection
any local and systemics events
Measured: 72 hours
Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.
any local and systemics events
Measured: 72 hours - 28 days
Percentage of serious adverse events within 28 days after injection
Any serious adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start29 Aug 2017
- Primary completion15 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indonesian Vaccine Safety Advisory Committee
- Responsible party
- Sponsor
- Investigators
- Julitasari Sundoro, MD, Principal investigator, Indonesian Vaccine Safety Advisory Commitee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383653
- Sponsor's protocol ID
- Td0417
- Status last verified
- Mar 2018
- First submitted
- 1 Nov 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
- ClinicalTrials.gov ID
- NCT03383653
- Acronym / sponsor ID
- Td0417
- Keywords
- Td Vaccine, Safety, Pregnant, Pregnant Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Indonesian Vaccine Safety Advisory Committee
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 200 pregnant woman, 18-39 years old From provincial health primary center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Any serious adverse event occurring from inclusion until 30 minutes after the injection
Time frame: 30 minutes
local and systemic reaction
3 secondary outcomes
Percentage of local and systemic events occurring within 72 hours after each injection
Time frame: 72 hours
Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.
Time frame: 72 hours - 28 days
Percentage of serious adverse events within 28 days after injection
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julitasari Sundoro, MD principal investigator
Indonesian Vaccine Safety Advisory Commitee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Pregnant, run by PT Bio Farma at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any serious adverse event occurring from inclusion until 30 minutes after the injection (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.