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Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants

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: NCT03460405
Recruitment Status : Active, not recruiting
First Posted : March 9, 2018
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma

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

Condition or disease Intervention/treatment Phase
Safety Issues Immunogenicity Biological: Vi-DT Vaccine Biological: Vi Polysaccharide Vaccine Biological: IPV Vaccine Phase 2

Detailed Description:

To describe the safety of this vaccine following one dose immunization in adults, adolescent, children and infants.

To assess immunogenicity following one dose of Vi-DT vaccine immunization. To compare the safety and immunogenicity of Vi-DT to Vi polysaccharide vaccine in adults, adolescents, and children groups.

To compare the safety and immunogenicity of Vi-DT to IPV vaccine in infants groups.

Kinetics of Vi-specific IgG antibodies up to 6 months and 1 year after administration of 1 dose of vaccine.

To evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in infants (≥ 9months -23 months old).

To evaluate the safety and immunogenicity of MR vaccine co-administered with Vi-DT vaccine in infants (≥ 9months -23 months old).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subject aged 2 - 40 years old:

Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.

Subject aged 6-23 months old:

Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).

Masking: Double (Participant, Investigator)
Masking Description:

Subject aged 2 - 40 years old:

Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.

Subject 6-23 months old:

Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).

Primary Purpose: Treatment
Official Title: Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VI-DT vaccine (adults,adolescent)
1 dose of 0.5 ml Vi-DT vaccine
Biological: Vi-DT Vaccine
1 dose of Vi-DT Vaccine
Other Name: Typhoid Conjugate Vaccine

Active Comparator: Vi polysaccharide (adults,adolescent)
1 dose of 0.5 ml Vi polysaccharide vaccine
Biological: Vi Polysaccharide Vaccine
1 dose of Vi Polysaccharide Vaccine

Experimental: VI-DT vaccine (children)
1 dose of 0.5 ml Vi-DT vaccine
Biological: Vi-DT Vaccine
1 dose of Vi-DT Vaccine
Other Name: Typhoid Conjugate Vaccine

Active Comparator: Vi polysaccharide vaccine (children)
1 dose of 0.5 ml Vi polysaccharide vaccine
Biological: Vi Polysaccharide Vaccine
1 dose of Vi Polysaccharide Vaccine

Experimental: VI-DT vaccine (infants)
1 dose of 0.5 ml Vi-DT vaccine
Biological: Vi-DT Vaccine
1 dose of Vi-DT Vaccine
Other Name: Typhoid Conjugate Vaccine

Active Comparator: IPV Vaccine (infants)
1 dose of 0.5 ml IPV vaccine
Biological: IPV Vaccine
1 dose of IPV 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: up to 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 1 dose 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

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

  4. Percentage of subjects with increasing antibody titer >= 4 times [ Time Frame: 28 days ]
    Percentage of subjects with increasing antibody titer >= 4 times in all subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months 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/legal guardians will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria For adults-adolescent-children:

  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, corticosteroid therapy and other immunosuppresant).
  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 1 month prior and expect to receive other vaccines within 1 month following immunization.
  10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
  11. History of substance abuse (Adults).
  12. Subject planning to move from the study area before the end of study period.

Exclusion Criteria for infants:

  1. Subject concomitantly enrolled or scheduled to be enrolled in another trial
  2. Mother less than 18 years of age at the age of enrollment of the infant
  3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
  4. Known history of allergy to any component of the vaccines
  5. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
  6. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).
  7. Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
  8. Individuals who have previously received any vaccines against typhoid fever.
  9. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine.
  10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
  11. 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): NCT03460405


Locations
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Indonesia
Puskesmas Jatinegara
Jakarta, Indonesia
Puskesmas Senen
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: NCT03460405     History of Changes
Other Study ID Numbers: Typhoid 0218
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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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
Immunologic Factors
Physiological Effects of Drugs