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Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03109600
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma

Brief Summary:
This study is to assess the safety of Vi-DT vaccine in adults and children.

Condition or disease Intervention/treatment Phase
Safety Issues Biological: Vi-DT (Bio Farma) Biological: Vi polysaccharide vaccine Biological: Influenzae vaccine Biological: Pneumococcal conjugate vaccine Phase 1

Detailed Description:

To describe the safety of this vaccine following first and second dose immunization.

To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : September 28, 2017
Actual Study Completion Date : February 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vi-DT (Bio Farma)
2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine
Biological: Vi-DT (Bio Farma)
Typhoid Conjugate Vaccine

Active Comparator: Vi polysaccharide vaccine
1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine
Biological: Vi polysaccharide vaccine
Vi polysaccharide vaccine

Biological: Influenzae vaccine
1 dose of Influenzae vaccine

Experimental: Vi-DT (Bio Farma) ~ Children
2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine
Biological: Vi-DT (Bio Farma)
Typhoid Conjugate Vaccine

Active Comparator: Vi polysaccharide vaccine ~ Children
1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine
Biological: Vi polysaccharide vaccine
Vi polysaccharide vaccine

Biological: Pneumococcal conjugate vaccine
1 dose of Pneumococcal conjugate Vaccine




Primary Outcome Measures :
  1. Local reaction and systemic event after vaccination [ Time Frame: 28 days ]
    Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.


Secondary Outcome Measures :
  1. Adverse events after vaccination [ Time Frame: 28 days ]
    Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each vaccination.

  2. Serious adverse events after vaccination [ Time Frame: 28 days ]
    Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination and up to 6 months after the last vaccination.

  3. Routine laboratory evaluation that probably related to the vaccination. [ Time Frame: 7 days ]
    Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination.

  4. Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT) [ Time Frame: 28 days ]
    Percentage of subjects with > 4 times increasing antibody

  5. Geometric Mean Titers (GMT) following immunization [ Time Frame: 28 days ]
    Geometric Mean Titers (GMT) 28 days following immunization



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Ages Eligible for Study:   2 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy
  2. Subjects/Parents have been informed properly regarding the study and signed the informed consent form
  3. Subject/Parents will commit 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. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
  3. Known history of allergy to any component of the vaccines
  4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
  5. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
  6. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
  7. Pregnancy & lactation (Adults)
  8. Individuals who have previously received any vaccines against typhoid fever.
  9. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
  10. Individuals who have a previously ascertained typhoid fever.
  11. History of alcohol or substance abuse.
  12. Subject planning to move from the study area before the end of 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): NCT03109600


Locations
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Indonesia
Puskesmas Jatinegara
Jakarta, DKI Jaya, Indonesia
Jatinegara Primary Health Center
Jakarta, Indonesia
Sponsors and Collaborators
PT Bio Farma
Investigators
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Principal Investigator: Bernie Endyarni, MD Faculty of Medicine, University of Indonesia

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Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT03109600     History of Changes
Other Study ID Numbers: Typhoid 0116
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: July 2017
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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Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs