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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185545
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma

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

Condition or disease Intervention/treatment Phase
Rotavirus Gastroenteritis Biological: Rotavirus RV3 Vaccine (Bio Farma) Other: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference With Co-Administered EPI Vaccines (Phase III)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: Main Study I - RV3 Vaccine (Bio Farma) Batch 1
3 oral doses of RV3 vaccine (Bio Farma) batch 1; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Biological: Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains > 5x10^6 fcfu/mL rotavirus vaccine strain RV3

Experimental: Main Study I - RV3 Vaccine (Bio Farma) Batch 2
3 oral doses of RV3 vaccine (Bio Farma) batch 2; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Biological: Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains > 5x10^6 fcfu/mL rotavirus vaccine strain RV3

Experimental: Main Study I - RV3 Vaccine (Bio Farma) Batch 3
3 oral doses of RV3 vaccine (Bio Farma) batch 3; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Biological: Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains > 5x10^6 fcfu/mL rotavirus vaccine strain RV3

Placebo Comparator: Main Study I - Placebo
3 oral doses of Placebo; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Other: Placebo
Each 1 mL dose of placebo contains 30% of sucrose in DMEM

Experimental: Main Study II - RV3 Vaccine (Bio Farma)
3 oral doses of RV3 vaccine (Bio Farma) with the addition of antacid prior to dose 2 and 3; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Biological: Rotavirus RV3 Vaccine (Bio Farma)
Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains > 5x10^6 fcfu/mL rotavirus vaccine strain RV3

Placebo Comparator: Main Study II - Placebo
3 oral doses of Placebo with the addition of antacid prior to dose 2 and 3; administered at 0-5 days, 8-10 weeks, and 12-14 weeks of age.
Other: Placebo
Each 1 mL dose of placebo contains 30% of sucrose in DMEM




Primary Outcome Measures :
  1. Serum immune response (sIgA) following third dose [ Time Frame: 28 days after the third dose ]
    Number and percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose


Secondary Outcome Measures :
  1. Serum anti-rotavirus IgA (sIgA) following third dose [ Time Frame: 28 days after the third dose ]
    Number and percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose

  2. Serum anti-rotavirus IgA (sIgA) following second dose [ Time Frame: 28 days after the second dose ]
    Number and percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose

  3. Serum anti-rotavirus IgA (sIgA) following first dose [ Time Frame: 28 days after the first dose ]
    Number and percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose

  4. Serum neutralizing antibodies (SNA) following third dose [ Time Frame: 28 days after the third dose ]
    Description of serum neutralising antibodies (SNA) level [number and percentage of subjects with positive SNA(≥ 100), two fold and three fold increasing antibodies] from baseline to 28 days after the third dose [in a subset of 80 participants per arm]

  5. Geometric mean titre (GMT) following third dose [ Time Frame: 28 days after the third dose ]
    Geometric mean titre (GMT) of serum IgA and serum neutralising antibodies (SNA) 28 days after the third dose

  6. Stool excretion following each dose [ Time Frame: 3-5 days after each dose ]
    Detectable RV3 excretion in stool (by PCR) any day from day 3 to day 5 following each dose

  7. Vaccine take [ Time Frame: 28 days after each dose ]
    At least a threefold increase in serum anti-rotavirus IgA or SNA from baseline to post rotavirus vaccine dosing, or detectable RV3 excretion in stool (by PCR) any day from day 3 to day 5 following a dose

  8. Cumulative vaccine take [ Time Frame: 28 days after the third dose ]
    Vaccine take observed at the current assessment time point or following any previous dose

  9. Lot to lot consistency [ Time Frame: 28 days after the third dose ]
    Assessed based on percentage of subjects with ≥ 3 times increase in serum anti-rotavirus IgA (sIgA) from baseline to 28 days after the third dose

  10. Seroprotective response [ Time Frame: 28 days after non-EPI vaccination ]
    Reciprocal titre ≥ 1:8 against poliovirus strains 1-3 measured 28 days after bOPV4+ IPV and Pentabio 3 vaccination

  11. Solicited and unsolicited adverse events (AE) [ Time Frame: Up to 28 days after the third dose ]
    Number of events of solicited and unsolicited Adverse Events (AE) from randomization to 28 days following last dose

  12. Serious adverse events (SAE) [ Time Frame: Up to 28 days after the third dose ]
    Number of events of Serious Adverse Events (SAE), from randomization to 28 days following last dose, and number of events

  13. AE and SAE compared to placebo [ Time Frame: Up to 28 days after the third dose ]
    Number of events of adverse event and Serious Adverse Events (SAE), from randomization to 28 days following last dose compared to placebo

  14. Abnormality of routine laboratory evaluation (ALT and AST) [ Time Frame: Up to 28 days after the third dose ]
    Abnormality detected in laboratory evaluation of ALT and AST that are assessed as probably or definitely related to the dosing



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Neonate 0-5 days (0-144 hours) of age at the time of first dose.
  2. 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.
  3. The neonate was born full term (minimum of 37 completed weeks and maximum of 42 completed weeks gestation).
  4. Neonate birth weight 2500-4000 g inclusive.
  5. Parent or guardian has been informed properly regarding the study and signed the informed consent form.
  6. Parent or guardian commits to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

  1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
  2. The subject has direct relatives relationship with the study team.
  3. The subject has evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
  4. Subject with a known or suspected history of allergy to any component of the vaccines (based on anamnesis).
  5. Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) infection.
  6. Subject with known or suspected major congenital malformations or genetically determined disease.
  7. Subject with intussusception.
  8. Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
  9. Subject with a known or suspected disease of the immune system or those who have received immunosuppressive therapy, including immunosuppressive courses of systemic corticosteroid.
  10. 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.
  11. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
  12. Subject immunized with non-EPI vaccines.
  13. Gastroenteritis in the 24 hours preceding dosing (temporary exclusion criteria).
  14. Subject planning to move from the study area before the end of the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185545


Contacts
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Contact: Novilia Sjafri Bachtiar +6222-2033755 ext 14101 novilia@biofarma.co.id

Locations
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Sponsors and Collaborators
PT Bio Farma
Investigators
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Principal Investigator: Jarir At Thobari Pediatric Research Office (PRO), Faculty of Medicine Universitas Gadjah Mada

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Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT04185545    
Other Study ID Numbers: RV 0319
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs