Safety IssuesPhase 2NCT03460405
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
A Phase 2 study testing Vi-DT Vaccine, Vi Polysaccharide Vaccine and IPV Vaccine in people with Safety Issues and Immunogenicity, run by PT Bio Farma at 2 sites in Indonesia.
Trial summary
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants. Read more about this study
- Who is it for?
- Ages 6 months to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Immunogenicity
- What is being tested?
- Vi-DT Vaccine, Vi Polysaccharide Vaccine and IPV Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesIndonesia
- Study dates
- 16 Jul 2018to 30 Jan 2020
- Phase
- Phase 2
- 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 6 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy
- Subjects/Parents have been informed properly regarding the study and signed the informed consent form
- Subject/parents/legal guardians will commit themselves 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
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
- Known history of allergy to any component of the vaccines
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- 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).
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
Show all 23Show fewer
- Pregnancy \& lactation (Adults)
- Individuals who have previously received any vaccines against typhoid fever.
- Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization.
- Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
- History of substance abuse (Adults).
- 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
- Mother less than 18 years of age at the age of enrollment of the infant
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
- Known history of allergy to any component of the vaccines
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- 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).
- 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.
- Individuals who have previously received any vaccines against typhoid fever.
- Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine.
- Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
- Subject planning to move from the study area before the end of study period.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
Read the 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).
- Conditions
- Safety Issues, Immunogenicity
- Being tested
- Vi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-DT VaccineBiological
Also called Typhoid Conjugate Vaccine
1 dose of Vi-DT Vaccine
Vi Polysaccharide VaccineBiological
1 dose of Vi Polysaccharide Vaccine
IPV VaccineBiological
1 dose of IPV Vaccine
| Study group | Role | What they receive |
|---|---|---|
| VI-DT vaccine (adults,adolescent) | Experimental | 1 dose of 0.5 ml Vi-DT vaccine Receives: Biological: Vi-DT Vaccine |
| Vi polysaccharide (adults,adolescent) | Active comparator | 1 dose of 0.5 ml Vi polysaccharide vaccine Receives: Biological: Vi Polysaccharide Vaccine |
| VI-DT vaccine (children) | Experimental | 1 dose of 0.5 ml Vi-DT vaccine Receives: Biological: Vi-DT Vaccine |
| Vi polysaccharide vaccine (children) | Active comparator | 1 dose of 0.5 ml Vi polysaccharide vaccine Receives: Biological: Vi Polysaccharide Vaccine |
| VI-DT vaccine (infants) | Experimental | 1 dose of 0.5 ml Vi-DT vaccine Receives: Biological: Vi-DT Vaccine |
| IPV Vaccine (infants) | Active comparator | 1 dose of 0.5 ml IPV vaccine Receives: Biological: IPV Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local reaction and systemic event after vaccination
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.
Measured: 28 days
Secondary outcomes (4)
Adverse events after vaccination
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.
Measured: up to 28 days
Serious adverse events after vaccination
Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination
Measured: 28 days
Geometric Mean Titers (GMT)
Geometric Mean Titers (GMT) 28 days following immunization
Measured: 28 days
Percentage of subjects with increasing antibody titer >= 4 times
Percentage of subjects with increasing antibody titer >= 4 times in all subjects
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start16 Jul 2018
- Primary completion31 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernie Endyarni, MD, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460405
- Sponsor's protocol ID
- Typhoid 0218
- Status last verified
- Feb 2020
- First submitted
- 4 Mar 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koesnoe S, Medise BE, Rengganis I, Hadinegoro SR, Puspita M, Sari RM, Yang JS, Sahastrabuddhe S, Soedjatmiko, Gunardi H, Sekartini R, Wirahmadi A, Kekalih A, Mukhi S, Satari HI, Bachtiar NS. A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity. Trop Dis Travel Med Vaccines. 2024 Feb 1;10(1):3. doi: 10.1186/s40794-023-00210-z.
PubMed 38297337Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report. BMC Pediatr. 2020 Oct 15;20(1):480. doi: 10.1186/s12887-020-02375-4.
PubMed 33059607Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine. Int J Infect Dis. 2020 Apr;93:102-107. doi: 10.1016/j.ijid.2020.01.045. Epub 2020 Jan 28.
PubMed 32004693
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)
- ClinicalTrials.gov ID
- NCT03460405
- Acronym / sponsor ID
- Typhoid 0218
- Conditions
- Safety Issues, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- 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).
| Arm | Type | Receives |
|---|---|---|
| VI-DT vaccine (adults,adolescent) | Experimental | Biological: Vi-DT Vaccine1 dose of 0.5 ml Vi-DT vaccine |
| Vi polysaccharide (adults,adolescent) | Active comparator | Biological: Vi Polysaccharide Vaccine1 dose of 0.5 ml Vi polysaccharide vaccine |
| VI-DT vaccine (children) | Experimental | Biological: Vi-DT Vaccine1 dose of 0.5 ml Vi-DT vaccine |
| Vi polysaccharide vaccine (children) | Active comparator | Biological: Vi Polysaccharide Vaccine1 dose of 0.5 ml Vi polysaccharide vaccine |
| VI-DT vaccine (infants) | Experimental | Biological: Vi-DT Vaccine1 dose of 0.5 ml Vi-DT vaccine |
| IPV Vaccine (infants) | Active comparator | Biological: IPV Vaccine1 dose of 0.5 ml IPV vaccine |
Who may qualify
- Ages
- 6 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy
- Subjects/Parents have been informed properly regarding the study and signed the informed consent form
- Subject/parents/legal guardians will commit themselves to comply with the instructions of the investigator and the schedule of the trial.
Key exclusion criteria (23 listed)
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
- Known history of allergy to any component of the vaccines
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vi-DT VaccineAlso: Typhoid Conjugate Vaccine1 dose of Vi-DT Vaccine | Biological | VI-DT vaccine (adults,adolescent), VI-DT vaccine (children), VI-DT vaccine (infants) |
| Vi Polysaccharide Vaccine1 dose of Vi Polysaccharide Vaccine | Biological | Vi polysaccharide (adults,adolescent), Vi polysaccharide vaccine (children) |
| IPV Vaccine1 dose of IPV Vaccine | Biological | IPV Vaccine (infants) |
Primary outcome
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.
4 secondary outcomes
Adverse events after vaccination
Time frame: up to 28 days
Serious adverse events after vaccination
Time frame: 28 days
Geometric Mean Titers (GMT)
Time frame: 28 days
Percentage of subjects with increasing antibody titer >= 4 times
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 38297337Koesnoe S, Medise BE, Rengganis I, Hadinegoro SR, Puspita M, Sari RM, Yang JS, Sahastrabuddhe S, Soedjatmiko, Gunardi H, Sekartini R, Wirahmadi A, Kekalih A, Mukhi S, Satari HI, Bachtiar NS. A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity. Trop Dis Travel Med Vaccines. 2024 Feb 1;10(1):3. doi: 10.1186/s40794-023-00210-z.
- Derived from this study: PubMed 33059607Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report. BMC Pediatr. 2020 Oct 15;20(1):480. doi: 10.1186/s12887-020-02375-4.
- Derived from this study: PubMed 32004693Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine. Int J Infect Dis. 2020 Apr;93:102-107. doi: 10.1016/j.ijid.2020.01.045. Epub 2020 Jan 28.
Related trials for Safety Issues
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruitingPhase 1
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
Safety Issues
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
Active, not recruitingPhase 1/2
Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
Safety Issues, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernie Endyarni, MD principal investigator
Faculty of Medicine, University of Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vi-DT Vaccine, Vi Polysaccharide Vaccine and IPV Vaccine in people with Safety Issues and Immunogenicity, run by PT Bio Farma at 2 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 3 inclusion and 23 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Local reaction and systemic event after vaccination (time frame: 28 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 NCT03460405, which also lists 3 linked publications.
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 20 Feb 2020.