HealthyNCT02093286
Safety Profile Following Pentabio Vaccination in Indonesian Infants
An observational study of Healthy, run by PT Bio Farma at 4 sites in Indonesia.
Trial summary
To assess any serious systemic reaction within 30 minutes after Pentabio immunization Read more about this study
- Who is it for?
- Ages 2 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 4,000 participants
- Where
- 4 sitesIndonesia
- Study dates
- May 2014to Dec 2014
- 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 2 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 4000 infants, 2-11 months old From 4 provincial health primary center
Who may be able to join
- 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
Who cannot join
- Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.
Trial locations and contacts
4 sites in 1 country.
Indonesia4 sites
Bali Provincial Ministry of Health
Bali
West Java Provincial Ministry of Health
Bandung, West Java
West Nusa Tenggara Provincial Ministry of Health
Mataram, West Nusa Tenggara
Yogyakarta Provincial Ministry of Health
Yogyakarta
About this study
Official title: Phase IV, Study of Safety Profile Following Pentabio Vaccination in Indonesian Infants
To assess any serious systemic reaction within 30 minutes after Pentabio immunization
Read the detailed description
Any local and systemic reaction after Pentabio immunization
- Conditions
- Healthy
- Keywords
- Pentabio Vaccine, Safety, Infants, Booster Dose, DTwP/HepB/Hib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pentabio Vaccine | 1 dose of Pentabio vaccine, 0.5 ml Will be given intramuscularly |
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 systemic events
Measured: 25 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 posted20 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionDec 2014
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julitasari Sundoro, MD, Principal investigator, AEFI National Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093286
- Sponsor's protocol ID
- PMS Penta 0414
- Status last verified
- Dec 2014
- First submitted
- 19 Mar 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Study of Safety Profile Following Pentabio Vaccination in Indonesian Infants
- ClinicalTrials.gov ID
- NCT02093286
- Acronym / sponsor ID
- PMS Penta 0414
- Conditions
- Healthy
- Keywords
- Pentabio Vaccine, Safety, Infants, Booster Dose, DTwP/HepB/Hib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Mar 2014 (estimated)
- 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 Pentabio immunization
Detailed description
Any local and systemic reaction after Pentabio immunization
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pentabio Vaccine | – | –1 dose of Pentabio vaccine, 0.5 ml Will be given intramuscularly |
Who may qualify
- Ages
- 2 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 4000 infants, 2-11 months old From 4 provincial health primary center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.
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: 25 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 Nov 2017.
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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
AEFI National Committee
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by PT Bio Farma at 4 sites 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 3 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Nov 2017.