TyphoidPhase 2NCT03527355
Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine
A Phase 2 study testing Vi-DT, FluQuadri™ and 0.9% sodium chloride isotonic solution in people with Typhoid, run by International Vaccine Institute at 1 site in Philippines.
Trial summary
This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose. The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age. Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Typhoid
- What is being tested?
- Vi-DT, FluQuadri™ and 0.9% sodium chloride isotonic solution
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 1 sitePhilippines
- Study dates
- 18 Apr 2018to 19 Jan 2021
- 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 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical judgment of the investigator
- Birth weight ≥ 2500 g
- ≥ 37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant
- Parents aged 18 years and above and legal guardians aged 21 years and above as per the legal authorization in the Philippines, who have voluntarily given informed consent
- Parents/ legal guardians willing to follow the study procedures of the study and available for the entire duration of the study
Who cannot join
- Child with a congenital abnormality
- Subject with abnormal routine biological values at screening
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination
- Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
- Child with a previously ascertained or suspected disease caused by S. typhi
Show all 13Show fewer
- Child who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
- Known history or allergy to vaccines or other medications
- Know history of allergy to eggs, chicken protein, neomycin and formaldehyde
- History of uncontrolled coagulopathy or blood disorders
- Mother has known HIV infection or other immune function disorders
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the study objectives
- Child whose parents or legal guardian planning to move from the study area before the end of study period
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Research Institute for Tropical Medicine(RITM)
Alabang, Muntinlupa City, 1781
About this study
Official title: A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers
This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose.
The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age.
The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.
Read the detailed description
This study is carried out in healthy children aged 6 to 23 months at a single site. A total of 285 participants are enrolled, 114, 114 and 57 participants are randomized to either the single dose, two-dose Vi-DT regimens or placebo/comparator group, respectively within age strata. Three age strata is 6 to less than 9 months, 9 to 12 months and 13 to 23 months. The investigators allow the 9-12 months old children to receive Measles-Mumps-Rubella (MMR) vaccine concomitantly with Vi-DT vaccine and descriptive analysis of immune response to MMR only and to MMR and Vi-DT vaccines are performed to assess the possible immunological interference with MMR vaccine.
- Conditions
- Typhoid
- Being tested
- Vi-DT, FluQuadri™, 0.9% sodium chloride isotonic solution
- Keywords
- Typhoid, Vi-DT, Conjugate vaccine, First in human, New vaccine
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-DTBiological
Also called Vi-DT typhoid conjugate vaccine
Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial
FluQuadri™Biological
Manufacturer: Sanofi Pasteur Dose: 0.25 ml
*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.
0.9% sodium chloride isotonic solutionOther
Manufacture: Euro-Med Inc. Dose: 0.5 mL
| Study group | Role | What they receive |
|---|---|---|
| A (Single dose) | Experimental | One dose of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly at first dost (Day 0).
One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Week 24).
One booster dose of Vi-DT 0.5 mL is administrated 2 years apart (Week 96). MMR for age group at 9-12 months. Receives: Biological: Vi-DT; Biological: FluQuadri™ |
| B (Two dose) | Active comparator | Two doses of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly 6 months apart (Day 0 and Day 168 (Week 24)).
MMR for age group at 9-12 months. Receives: Biological: Vi-DT |
| C (Placebo/Comparator) | Placebo comparator | One dose of Placebo (0.9% sodium chloride isotonic solution) 0.5 mL is administrated intramuscularly at first dost (Day 0).
One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Day 168; Week 24).
MMR for age group at 9-12 months. Receives: Biological: FluQuadri™; Other: 0.9% sodium chloride isotonic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints: solicited and unsolicited adverse events and serious adverse events
- Frequency (percentage) of solicited local reactions at the injection site: Pain, tenderness, erythema/redness, swelling/induration and pruritus local
- Frequency (percentage) of solicited systemic reactions: Fever, lethargy, irritability, vomiting, diarrhea, drowsiness, loss of appetite, persistent crying, rash and nasopharyngitis
- Frequency (percentage) of unsolicited adverse events
- Frequency (percentage) of serious adverse events
Measured: Solicited AE: during 7 days after each vaccination. Unsolicited AE: after the first vaccination until 4 weeks after the second vaccination. SAE will be captured after the first vaccination up to week 100 for Group A, week 96 for Group B, week 36 Group C
Secondary outcomes (1)
Immunogenicity Endpoints
Seroconversion rate of anti-Vi IgG by Geometric Mean Titers (GMT) will be measured 4 weeks after the second vaccination using an in-house ELISA assay using standardized reagents and reference serum. The level of the specific anti-Vi IgG in ELISA units for each serum sample is determined by comparison to a reference serum. The number of anti-Vi IgG positive sera will be used to calculate the seroconversion rates.
Measured: At week 28, 4 weeks after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start18 Apr 2018
- Primary completion28 Jul 2018
- Study completion19 Jan 2021
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 TyphoidStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants age 6-23 months
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- SK Bioscience Co., Ltd., Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Maria Rosario Capeding, MD, Principal investigator, Research Institute for Tropical Medicine, Metro Manila, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527355
- Sponsor's protocol ID
- IVI T002
- Status last verified
- Apr 2020
- First submitted
- 12 Feb 2018
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pial RH, Capeding MR, Song KR, Park EL, Park IY, Yang JS, Kim S, Lee EY, Eluru JR, Kwon SY, Jo SK, Ryu JH, Park HK, Shin JH, Yang SY, Kim DR, Song M, Wartel TA, Kim HS, Saluja T, Sahastrabuddhe S. Immune persistence after 5 years of vaccination by Vi-DT vaccine among children below 2 years: Result from long-term observational study. Vaccine. 2025 Jul 11;60:127304. doi: 10.1016/j.vaccine.2025.127304. Epub 2025 May 29.
PubMed 40446606Capeding MR, Sil A, Tadesse BT, Saluja T, Teshome S, Alberto E, Kim DR, Park EL, Park JY, Yang JS, Chinaworapong S, Park J, Jo SK, Chon Y, Yang SY, Ryu JH, Cheong I, Shim KY, Lee Y, Kim H, Lynch JA, Kim JH, Excler JL, Wartel TA, Sahastrabuddhe S. Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: Phase II, randomized, dose-scheduling, observer-blind Study. EClinicalMedicine. 2020 Sep 9;27:100540. doi: 10.1016/j.eclinm.2020.100540. eCollection 2020 Oct.
PubMed 33150320Capeding MR, Alberto E, Sil A, Saluja T, Teshome S, Kim DR, Park JY, Yang JS, Chinaworapong S, Park J, Jo SK, Chon Y, Yang SY, Ham DS, Ryu JH, Lynch J, Kim JH, Kim H, Excler JL, Wartel TA, Sahastrabuddhe S. Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report. Vaccine. 2020 Jun 9;38(28):4476-4483. doi: 10.1016/j.vaccine.2019.09.074. Epub 2019 Oct 1.
PubMed 31585725
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers
- ClinicalTrials.gov ID
- NCT03527355
- Acronym / sponsor ID
- IVI T002
- Conditions
- Typhoid
- Keywords
- Typhoid, Vi-DT, Conjugate vaccine, First in human, New vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- SK Bioscience Co., Ltd., Bill and Melinda Gates Foundation
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 28 Jul 2018 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 17 May 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 is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose.
The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age.
The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.
Detailed description
This study is carried out in healthy children aged 6 to 23 months at a single site. A total of 285 participants are enrolled, 114, 114 and 57 participants are randomized to either the single dose, two-dose Vi-DT regimens or placebo/comparator group, respectively within age strata. Three age strata is 6 to less than 9 months, 9 to 12 months and 13 to 23 months. The investigators allow the 9-12 months old children to receive Measles-Mumps-Rubella (MMR) vaccine concomitantly with Vi-DT vaccine and descriptive analysis of immune response to MMR only and to MMR and Vi-DT vaccines are performed to assess the possible immunological interference with MMR vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants age 6-23 months
| Arm | Type | Receives |
|---|---|---|
| A (Single dose) | Experimental | Biological: Vi-DT, Biological: FluQuadri™One dose of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly at first dost (Day 0). One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Week 24). One booster dose of Vi-DT 0.5 mL is administrated 2 years apart (Week 96). MMR for age group at 9-12 months. |
| B (Two dose) | Active comparator | Biological: Vi-DTTwo doses of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly 6 months apart (Day 0 and Day 168 (Week 24)). MMR for age group at 9-12 months. |
| C (Placebo/Comparator) | Placebo comparator | Biological: FluQuadri™, Other: 0.9% sodium chloride isotonic solutionOne dose of Placebo (0.9% sodium chloride isotonic solution) 0.5 mL is administrated intramuscularly at first dost (Day 0). One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Day 168; Week 24). MMR for age group at 9-12 months. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical judgment of the investigator
- Birth weight ≥ 2500 g
- ≥ 37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant
- Parents aged 18 years and above and legal guardians aged 21 years and above as per the legal authorization in the Philippines, who have voluntarily given informed consent
- Parents/ legal guardians willing to follow the study procedures of the study and available for the entire duration of the study
Key exclusion criteria (13 listed)
- Child with a congenital abnormality
- Subject with abnormal routine biological values at screening
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination
- Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
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-DTAlso: Vi-DT typhoid conjugate vaccineManufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial | Biological | A (Single dose), B (Two dose) |
| FluQuadri™Manufacturer: Sanofi Pasteur Dose: 0.25 ml *Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding. | Biological | A (Single dose), C (Placebo/Comparator) |
| 0.9% sodium chloride isotonic solutionManufacture: Euro-Med Inc. Dose: 0.5 mL | Other | C (Placebo/Comparator) |
Primary outcome
Safety endpoints: solicited and unsolicited adverse events and serious adverse events
Time frame: Solicited AE: during 7 days after each vaccination. Unsolicited AE: after the first vaccination until 4 weeks after the second vaccination. SAE will be captured after the first vaccination up to week 100 for Group A, week 96 for Group B, week 36 Group C
* Frequency (percentage) of solicited local reactions at the injection site: Pain, tenderness, erythema/redness, swelling/induration and pruritus local * Frequency (percentage) of solicited systemic reactions: Fever, lethargy, irritability, vomiting, diarrhea, drowsiness, loss of appetite, persistent crying, rash and nasopharyngitis * Frequency (percentage) of unsolicited adverse events * Frequency (percentage) of serious adverse events
1 secondary outcome
Immunogenicity Endpoints
Time frame: At week 28, 4 weeks after the second vaccination
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 27 Aug 2021.
- Derived from this study: PubMed 40446606Pial RH, Capeding MR, Song KR, Park EL, Park IY, Yang JS, Kim S, Lee EY, Eluru JR, Kwon SY, Jo SK, Ryu JH, Park HK, Shin JH, Yang SY, Kim DR, Song M, Wartel TA, Kim HS, Saluja T, Sahastrabuddhe S. Immune persistence after 5 years of vaccination by Vi-DT vaccine among children below 2 years: Result from long-term observational study. Vaccine. 2025 Jul 11;60:127304. doi: 10.1016/j.vaccine.2025.127304. Epub 2025 May 29.
- Derived from this study: PubMed 33150320Capeding MR, Sil A, Tadesse BT, Saluja T, Teshome S, Alberto E, Kim DR, Park EL, Park JY, Yang JS, Chinaworapong S, Park J, Jo SK, Chon Y, Yang SY, Ryu JH, Cheong I, Shim KY, Lee Y, Kim H, Lynch JA, Kim JH, Excler JL, Wartel TA, Sahastrabuddhe S. Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: Phase II, randomized, dose-scheduling, observer-blind Study. EClinicalMedicine. 2020 Sep 9;27:100540. doi: 10.1016/j.eclinm.2020.100540. eCollection 2020 Oct.
- Derived from this study: PubMed 31585725Capeding MR, Alberto E, Sil A, Saluja T, Teshome S, Kim DR, Park JY, Yang JS, Chinaworapong S, Park J, Jo SK, Chon Y, Yang SY, Ham DS, Ryu JH, Lynch J, Kim JH, Kim H, Excler JL, Wartel TA, Sahastrabuddhe S. Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report. Vaccine. 2020 Jun 9;38(28):4476-4483. doi: 10.1016/j.vaccine.2019.09.074. Epub 2019 Oct 1.
- A preliminary reportLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Maria Rosario Capeding, MD principal investigator
Research Institute for Tropical Medicine, Metro Manila, Philippines
1 site 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, FluQuadri™ and 0.9% sodium chloride isotonic solution in people with Typhoid, run by International Vaccine Institute at 1 site in Philippines.
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 5 inclusion and 13 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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 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?
Safety endpoints: solicited and unsolicited adverse events and serious adverse events (time frame: Solicited AE: during 7 days after each vaccination. Unsolicited AE: after the first vaccination until 4 weeks after the second vaccination. SAE will be captured after the first vaccination up to week 100 for Group A, week 96 for Group B, week 36 Group C). 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 NCT03527355, 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 27 Aug 2021.