Typhoid FeverNCT02391909
Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers
An observational study of Typhoid Fever, run by Bavarian Nordic at 1 site in United States.
Trial summary
This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- Vivotif
- Type of treatment
- Pill or oral medicine
- How many people
- 855 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2015to 21 Feb 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Travelers attending travelers' vaccination clinics, and for whom typhoid vaccination with Vivotif is recommended, according to standard practice
Who may be able to join
- Subjects are male or female aged ≥ 18 years at time of dosing
- Subjects are travelers attending travelers' vaccination clinics
- Subjects are eligible for typhoid vaccination, according to standard practice
- Subjects are expected to be able to provide follow-up information
- Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period)
- Subjects must sign a written informed consent
Who cannot join
- Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule
- Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs
- Subjects with an acute febrile illness
- Subjects with acute gastrointestinal (GI) illness
- Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment
- Subjects with other contraindications as determined by the site investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Observational Prospective Cohort Study to Assess the Safety of Vivotif at Different Release Titers Among Travelers
This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.
Read the detailed description
This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.
The study will enroll 950 subjects who will be randomized at a ratio of 1:1 into two groups, A and B, of 475 subjects each. Group A will receive 6.9-10.0 x109 CFU/capsule and Group B will receive 4.0-6.8 x109 CFU/capsule, respectively.
All subjects will receive four doses of Vivotif. One dose per subject will be administered on Days 1, 3, 5 and 7.
Investigators, subjects and all personnel involved in running the study will not be aware of the actual release titer associated with the distributed lots. Blinding is maintained using the commercial packaging that does not include the actual value of the release titer.
- Conditions
- Typhoid Fever
- Being tested
- Vivotif
- Keywords
- 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.
VivotifBiological
| Study group | Role | What they receive |
|---|---|---|
| Group A | Vivotif 6.9-10.0 x109 CFU/capsule Receives: Biological: Vivotif | |
| Group B | Vivotif 4.0-6.8 x109 CFU/capsule Receives: Biological: Vivotif |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of any AE up to two weeks after the scheduled final vaccine dose
Measured: Day 21
Secondary outcomes (4)
The distribution of the solicited Adverse Reactions
Measured: Day 21
The distribution of unsolicited Adverse Reactions
Measured: Day 21
The occurrence of any unsolicited adverse event up to two weeks after the scheduled final vaccine dose
Measured: Day 21
The occurrence of any SAE up to two weeks after the scheduled final vaccine dose
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start26 Aug 2015
- Primary completion6 Oct 2016
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typhoid FeverStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 855 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent BioSolutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391909
- Sponsor's protocol ID
- VIV-PASS-01
- Status last verified
- Jul 2023
- First submitted
- 12 Mar 2015
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Observational Prospective Cohort Study to Assess the Safety of Vivotif at Different Release Titers Among Travelers
- ClinicalTrials.gov ID
- NCT02391909
- Acronym / sponsor ID
- VIV-PASS-01
- Conditions
- Typhoid Fever
- Keywords
- Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 855 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- Emergent BioSolutions
- Study start
- 26 Aug 2015 (actual)
- Primary completion
- 6 Oct 2016 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 18 Mar 2015 (estimated)
- 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 multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.
Detailed description
This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.
The study will enroll 950 subjects who will be randomized at a ratio of 1:1 into two groups, A and B, of 475 subjects each. Group A will receive 6.9-10.0 x109 CFU/capsule and Group B will receive 4.0-6.8 x109 CFU/capsule, respectively.
All subjects will receive four doses of Vivotif. One dose per subject will be administered on Days 1, 3, 5 and 7.
Investigators, subjects and all personnel involved in running the study will not be aware of the actual release titer associated with the distributed lots. Blinding is maintained using the commercial packaging that does not include the actual value of the release titer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Biological: VivotifVivotif 6.9-10.0 x109 CFU/capsule |
| Group B | – | Biological: VivotifVivotif 4.0-6.8 x109 CFU/capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Travelers attending travelers' vaccination clinics, and for whom typhoid vaccination with Vivotif is recommended, according to standard practice
Key inclusion criteria (6 listed)
- Subjects are male or female aged ≥ 18 years at time of dosing
- Subjects are travelers attending travelers' vaccination clinics
- Subjects are eligible for typhoid vaccination, according to standard practice
- Subjects are expected to be able to provide follow-up information
- Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period)
Key exclusion criteria (6 listed)
- Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule
- Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs
- Subjects with an acute febrile illness
- Subjects with acute gastrointestinal (GI) illness
- Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment
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 |
|---|---|---|
| Vivotif | Biological | Group A, Group B |
Primary outcome
The occurrence of any AE up to two weeks after the scheduled final vaccine dose
Time frame: Day 21
4 secondary outcomes
The distribution of the solicited Adverse Reactions
Time frame: Day 21
The distribution of unsolicited Adverse Reactions
Time frame: Day 21
The occurrence of any unsolicited adverse event up to two weeks after the scheduled final vaccine dose
Time frame: Day 21
The occurrence of any SAE up to two weeks after the scheduled final vaccine dose
Time frame: Day 21
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 7 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Typhoid Fever, run by Bavarian Nordic at 1 site in United States.
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 6 inclusion and 6 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 7 Jul 2023. 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 United States. 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.
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?
The occurrence of any AE up to two weeks after the scheduled final vaccine dose (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.