AzTrials
AzTrials

Safety IssuesPhase 1NCT03462108

Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

A Phase 1 study testing Rotavirus (Bio Farma) Vaccine in people with Safety Issues, run by PT Bio Farma at 4 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates. Read more about this study

Who is it for?
Ages 1 minute to 40 yearsHealthy volunteers can take part
Conditions the study is for
Safety Issues
What is being tested?
Rotavirus (Bio Farma) Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
4 sitesIndonesia
Study dates
9 Apr 2018to 30 Mar 2019
Phase
Phase 1
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 1 minute to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy Adults as determined by clinical judgment, including a medical history, physical exam and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.
  • Subjects 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.
  • Healthy Children as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
  • Parents/guardian(s) have been informed properly regarding the study and signed the informed consent form
  • Parent/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
Show all 12Show fewer
  • Neonate 0-5 days of age at the time of first dose, with cord blood available
  • Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
  • The neonate was born full term (minimum of 36 completed weeks and maximum of 42 completed weeks gestation).
  • Neonate birth weight 2500-4000 g inclusive.
  • Parents or guardians have been informed properly regarding the study and signed the informed consent form
  • Parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial

Who cannot join

  • Subject concomitantly enrolled or scheduled to be enrolled in another trial
  • Any direct relatives relationship with the study team.
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
  • Known history of allergy to any component of the vaccines
  • Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
  • Gastroenteritis in the 24 hours preceding enrollment.
Show all 41Show fewer
  • History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
  • Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or corticosteroid therapy and other immunosuppresant).
  • Subject consuming or expect to consume a probiotics within one week before and after vaccination
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
  • Pregnancy \& lactation (Adults).
  • Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
  • Subject planning to move from the study area before the end of study period.
  • Subject concomitantly enrolled or scheduled to be enrolled in another trial
  • Any direct relatives relationship with the study team
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C ) within the 48 hours preceding enrollment
  • Known history of allergy to any component of the vaccines
  • Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
  • Gastroenteritis in the 24 hours preceding enrollment.
  • Any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for Intusussception.
  • History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
  • Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant).
  • Subjects consuming or expect to consume a probiotics within one week before and after vaccination.
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
  • Individuals who have previously received any rotavirus vaccine.
  • Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
  • Subject planning to move from the study area before the end of study period
  • Subject concomitantly enrolled or scheduled to be enrolled in another trial.
  • Any direct relatives relationship with the study team.
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
  • Subject with known or suspected history of allergy to any component of the vaccines.
  • Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) infection.
  • Subject with known or suspected major congenital malformations or genetically determined disease.
  • Subject with intussusception.
  • Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
  • Subject with a known or suspected disease of the immune system or those who has received immunosuppresive therapy, including immunosuppresive courses of systemic corticosteroid.
  • Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of study.
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
  • Subject immunized with non- EPI vaccines.
  • Gastroenteritis in the 24 hours preceding enrollment.
  • Subject planning to move from the study area before the end of study period.

Trial locations and contacts

4 sites in 1 country.

Indonesia4 sites

  • Gantiwarno Primary Health Center

    Klaten, Central Java

  • Klaten Selatan Primary Health Center

    Klaten, Central Java

  • Ngawen Primary Health Center

    Klaten, Central Java

  • RS Soeradji Tritonegoro

    Klaten, Central Java

Other trials in Indonesia

About this study

Official title: A Prospective Intervention Phase I Study in Three Age De-escalating Group to Assess the Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.

Read the detailed description

To describe the safety of this vaccine after each immunization. To assess preliminary information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.

Conditions
Safety Issues
Being tested
Rotavirus (Bio Farma) Vaccine, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotavirus (Bio Farma) VaccineBiological

    Rotavirus (Bio Farma) Vaccine

  • PlaceboOther

    Placebo contains 30% sucrose in DMEM

Study groups in NCT03462108
Study groupRoleWhat they receive
Rotavirus (Bio Farma) Vaccine-AdultExperimental1 doses of 1 ml of Rotavirus vaccine per oral
Receives: Biological: Rotavirus (Bio Farma) Vaccine
Rotavirus (Bio Farma) Vaccine-ChildrenExperimental1 doses of 1 ml of Rotavirus vaccine per oral
Receives: Biological: Rotavirus (Bio Farma) Vaccine
Rotavirus (Bio Farma) Vaccine-NeonatesExperimental3 doses of 1 ml of Rotavirus vaccine per oral
Receives: Biological: Rotavirus (Bio Farma) Vaccine
Placebo-NeonatesPlacebo comparator3 doses of 1 ml of Placebo (contains 30% sucrose in DMEM) per oral
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Solicited symptoms after each immunization

    Number of subjects with solicited systemic and gastrointestinal symptoms in the day 0-7 following each dose of investigational product

    Measured: 0-7 days

Secondary outcomes (10)

  1. Adverse events of Rotavirus (Bio Farma) vaccine

    Number and percentage of subjects with unsolicited Adverse Events (AE) in the day 0-28 following each dose of investigational product

    Measured: 28 days

  2. Serious adverse events of Rotavirus (Bio Farma) vaccine

    Number and percentage of subjects with Serious Adverse Events (SAE) within 28 days after each dose of investigational product

    Measured: 28 days

  3. Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group

    Number and percentage of subject with adverse event (AE) within 28 days after each dose of investigational product compare to placebo (in neonates group)

    Measured: 28 days

  4. Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group

    Number and percentage of subject with Serious Adverse Events (SAE) within 28 days after each dose of investigational product compare to placebo (in neonates group)

    Measured: 28 days

  5. Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination

    Deviation in routine hematology and biochemical evaluation

    Measured: 7 days

  6. Excretion of rotavirus in stools in neonates group

    Number of neonates with rotavirus excretion in stools

    Measured: 3-7 days

  7. Number of subjects with >=3 times increasing antibody from baseline to post investigational product dosing

    Subjects with >=3 times increasing antibody from baseline to post investigational product dosing

    Measured: 4-6 weeks after last immunization

  8. Serum anti-rotavirus immunoglobulin (Ig)A following immunization

    Serum anti-rotavirus immunoglobulin (Ig)A before and after last immunization

    Measured: 4-6 weeks after last immunization

  9. Serum neutralizing antibody (SNA) following immunization

    Serum neutralizing antibody (SNA) before and after last immunization

    Measured: 4-6 weeks after last immunization

  10. Geometric Mean Titer (GMT) following immunization

    Geometric mean titer (GMT) before and after last immunization

    Measured: 4-6 weeks after last immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2018
  2. Study start9 Apr 2018
  3. Primary completion18 Feb 2019
  4. Study completion30 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
* Adults and Children Group: Experimental, open labeled, prospective intervention study * Neonates Group: Experimental, randomized, double blind, prospective intervention study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03462108
Sponsor's protocol ID
RV 0117
Status last verified
Apr 2018
First submitted
29 Sep 2017
Last updated
3 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rotavirus (Bio Farma) Vaccine in people with Safety Issues, 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 12 inclusion and 41 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 3 Apr 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Solicited symptoms after each immunization (time frame: 0-7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03462108.

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 3 Apr 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in