AzTrials
AzTrials

Rotavirus GastroenteritisPhase 3NCT04185545

Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates

A Phase 3 study testing Rotavirus RV3 Vaccine (Bio Farma) in people with Rotavirus Gastroenteritis, run by PT Bio Farma at 21 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 phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines Read more about this study

Who is it for?
Ages 1 minute to 5 daysHealthy volunteers can take part
Conditions the study is for
Rotavirus Gastroenteritis
What is being tested?
Rotavirus RV3 Vaccine (Bio Farma)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,400 participants
Where
21 sitesIndonesia
Study dates
30 Oct 2020to 30 May 2023
Phase
Phase 3
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 5 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Neonate 0-5 days (0-144 hours) of age at the time of first dose.
  • 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 37 completed weeks and maximum of 42 completed weeks gestation).
  • Neonate birth weight 2500-4000 g inclusive.
  • Parent or guardian has been informed properly regarding the study and signed the informed consent form.
  • Parent or guardian commits 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.
  • The subject has direct relatives relationship with the study team.
  • The subject has evolving mild, moderate or severe illness, especially infectious diseases or fever (body temperature 37.5°C) within the 48 hours preceding enrollment.
  • Subject with a known or suspected history of allergy to any component of the vaccines (based on anamnesis).
  • Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) or Hepatitis B infection.
  • Subject with known or suspected major congenital malformations or genetically determined disease.
Show all 14Show fewer
  • 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 have received immunosuppressive therapy, including immunosuppressive courses of systemic corticosteroid.
  • Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product is anticipated 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 dosing (temporary exclusion criteria).
  • Subject planning to move from the study area before the end of the study period.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Indonesia21 sites

  • Dr. Moewardi District Hospital

    Surakarta

  • Gajahan Primary Health Center

    Surakarta

  • Gambirsari Primary Health Center

    Surakarta

  • Pajang Primary Health Center

    Surakarta

  • Sangkrah Primary Health Center

    Surakarta

  • Sibela Primary Health Center

    Surakarta

  • Bayat Primary Health Center

    Yogyakarta

  • dr. Soeradji Tirtonegoro General Hospital

    Yogyakarta

  • Gantiwarno Primary Health Center

    Yogyakarta

  • Jogonalan 1 Primary Health Center

    Yogyakarta

  • Jogonalan 2 Primary Health Center

    Yogyakarta

  • Karanganom Primary Health Center

    Yogyakarta

  • Kebonarum Primary Health Center

    Yogyakarta

  • Kebondalem Lor Primary Health Center

    Yogyakarta

  • Klaten Selatan Primary Health Center

    Yogyakarta

  • Ngawen Primary Health Center

    Yogyakarta

  • Pedan Primary Health Center

    Yogyakarta

  • Prambanan Primary Health Center

    Yogyakarta

  • Trucuk 1 Primary Health Center

    Yogyakarta

  • Trucuk 2 Primary Health Center

    Yogyakarta

  • Wedi Primary Health Center

    Yogyakarta

Other trials in Indonesia

About this study

Official title: Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference With Co-Administered EPI Vaccines (Phase III)

This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines

Read the detailed description

This study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity following three doses of rotavirus RV3 vaccine (Bio Farma) administered as a neonatal schedule

Being tested
Rotavirus RV3 Vaccine (Bio Farma), Placebo
Keywords
Rotavirus, Vaccine

What participants receive

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

  • Rotavirus RV3 Vaccine (Bio Farma)Biological

    Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains > 5x10^6 fcfu/mL rotavirus vaccine strain RV3

  • PlaceboOther

    Each 1 mL dose of placebo contains 30% of sucrose in DMEM

Study groups in NCT04185545
Study groupRoleWhat they receive
Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 1Experimental3 oral doses of RV3 vaccine (Bio Farma) batch 1; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Receives: Biological: Rotavirus RV3 Vaccine (Bio Farma)
Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 2Experimental3 oral doses of RV3 vaccine (Bio Farma) batch 2; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Receives: Biological: Rotavirus RV3 Vaccine (Bio Farma)
Immunogenicity Group - RV3 Vaccine (Bio Farma) Batch 3Experimental3 oral doses of RV3 vaccine (Bio Farma) batch 3; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Receives: Biological: Rotavirus RV3 Vaccine (Bio Farma)
Immunogenicity Group - PlaceboPlacebo comparator3 oral doses of Placebo; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Receives: Other: Placebo
Other Efficacy Group - RV3 Vaccine (Bio Farma)Experimental3 oral doses of RV3 vaccine (Bio Farma) administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Receives: Biological: Rotavirus RV3 Vaccine (Bio Farma)
Other Efficacy Group - PlaceboPlacebo comparator3 oral doses of Placebo administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Receives: Other: Placebo

What is being measured

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

  1. Efficacy of three doses against severe acute rotavirus gastroenteritis

    Episodes of severe rotavirus gastroenteritis (defined as a modified Vesikari score ≥ 11 and rotavirus antigen detected in stool by ELISA)

    Measured: 2 weeks after three doses to 18 months of age

Secondary outcomes (13)

  1. Efficacy of three doses against rotavirus gastroenteritis of any severity and all-cause gastroenteritis

    Episodes of rotavirus gastroenteritis of any severity (based on modified Vesikari score and rotavirus antigen detected in stool by ELISA) and all-cause gastroenteritis

    Measured: 2 weeks after three doses to 18 months of age

  2. Serum immune response (sIgA) after third dose

    Percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose

    Measured: 28 days after the third dose

  3. Stool excretion following each dose

    Detectable RV3 excretion in stool (by PCR) any day from day 3 to day 5 following each dose

    Measured: 3-5 days after each dose

  4. Cumulative serum immune response

    Cumulative serum anti-rotavirus IgA (sIgA) following each dose

    Measured: 28 days after each dose

  5. Lot to lot consistency

    Percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose

    Measured: 28 days after the third dose

  6. Solicited and unsolicited adverse events (AE)

    Number of solicited and unsolicited Adverse Events (AE), from randomization to 28 days following last dose

    Measured: Up to 28 days after the third dose

  7. Serious adverse events (SAE)

    Number of Serious Adverse Events (SAE), from randomization to 28 days following last dose

    Measured: Up to 28 days after the third dose

  8. Serum immune response (sIgA) after the first dose

    Percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the first dose

    Measured: 28 days after the first dose

  9. Serum immune response (sIgA) after the second dose

    Percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the second dose

    Measured: 28 days after the second dose

  10. Abnormality of ALT and AST levels

    Abnormality of ALT and AST levels measured 28 days following first dose, assessed as probably or definitely related to the dosing

    Measured: 28 days after the first dose

  11. Immune interference

    Percentage of subjects with reciprocal titre ≥ 1:8 against poliovirus strains 1-3 measured 28 days after bOPV4+ IPV and Pentabio 3 vaccination

    Measured: 28 days after non-EPI vaccination

  12. Geometric Mean Titre (GMT)

    Geometric Mean Titre (GMT) of serum IgA 28 days after each dose

    Measured: 28 days after each dose

  13. Serum neutralizing antibodies (SNA) after the third dose

    Percentage of subjects with positive SNA (≥ 100), two-fold and three-fold increasing antibodies from baseline to 28 days after the third dose

    Measured: 28 days after the third dose

Timeline

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

  1. First posted4 Dec 2019
  2. Study start30 Oct 2020
  3. Primary completion30 Apr 2022
  4. Study completion30 May 2023

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04185545
Sponsor's protocol ID
RV 0319
Status last verified
Nov 2023
First submitted
27 Nov 2019
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rotavirus RV3 Vaccine (Bio Farma) in people with Rotavirus Gastroenteritis, run by PT Bio Farma at 21 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 6 inclusion and 14 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Efficacy of three doses against severe acute rotavirus gastroenteritis (time frame: 2 weeks after three doses to 18 months of age). 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 NCT04185545.

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 29 Nov 2023.

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