TyphoidPhase 2NCT03614533
Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso
A Phase 2 study testing Vi-Typhoid Conjugate Vaccine (Vi-TCV) and Inactivated Poliovirus Vaccine (IPV) in people with Typhoid, run by University of Maryland, Baltimore at 1 site in Burkina Faso.
Trial summary
Typhoid fever is an illness that may cause mild effects in children, such as fever and feeling tired, or it may cause serious effects-- even death. A new typhoid vaccine has recently been recommended by the World Health Organization (WHO) to prevent typhoid in children. Read more about this study
- Who is it for?
- Ages 9 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Typhoid
- What is being tested?
- Vi-Typhoid Conjugate Vaccine (Vi-TCV) and Inactivated Poliovirus Vaccine (IPV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 3 Dec 2018to 22 Aug 2024
- 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 9 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: Each subject receiving study vaccine (Vi-TCV or IPV) must satisfy the following inclusion criteria at study entry:
- Male or female child 9 through11 months of age for cohort 1, or 15 months through 23 months of age for cohort 2, and in good health at the time of study vaccination.
- A child whose parent or guardian resides primarily within the study area at the time of study vaccinations and who intends to be present in the area for the duration of the trial.
- A child whose parent or guardian has voluntarily given informed consent.
Exclusion Criteria: No subject receiving study vaccine (Vi-TCV or IPV) may have any of the following exclusion criteria at study entry:
- History of documented hypersensitivity to any component of the vaccine.
- Prior receipt of any typhoid vaccine.
- History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness.
- Severe malnutrition as determined by a MUAC < 12.5 cm.
- Receipt of any other investigational intervention in the last 6 months or anticipated during the course of the study.
- Receipt of blood products in the last 6 months.
- Known HIV infection or exposure or other immunosuppressive conditions.
- Receipt of systemic immunosuppressant or systemic corticosteroids.
- Receipt of any measles-rubella-containing vaccine for children younger than 1 year of age.
- Any condition determined by the investigator likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study.
Temporary Exclusion Criteria: The following will be considered a temporary contraindication to enrollment and vaccination. If this applies, the participant will be temporarily excluded for vaccination until 48 hours has passed. A re-assessment will be needed to ensure the temporary exclusion criteria no longer exist:
- Reported fever within 24 hours before vaccination.
An additional temporary exclusion criteria for cohort 2 will be:
- Receipt of measles-rubella vaccine in the one month before enrollment, as determined by parental history or vaccination card. A child may be reassessed after 30 days has passed since receipt of MR vaccine.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Groupe de Recherche Action en Santé (GRAS)
Ouagadougou
About this study
Official title: A Phase 2 Randomized, Double-Blind, Controlled Trial of the Safety and Immunogenicity of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso
Typhoid fever is an illness that may cause mild effects in children, such as fever and feeling tired, or it may cause serious effects-- even death. A new typhoid vaccine has recently been recommended by the World Health Organization (WHO) to prevent typhoid in children. But this new typhoid vaccine has not been tested with all of the vaccines given to children in Burkina Faso. The investigators want to look at this new vaccine, and study how safe it is in children in Burkina Faso and how their immune systems respond to the vaccine when given with other vaccines, such as yellow fever and meningitis A vaccines.
The investigators plan to vaccinate 100 children between the ages of 9-11 months, and 150 children between the ages of 15 months and 2 years, in Ouagadougou, Burkina Faso, with either the typhoid vaccine or a vaccine against another illness called polio.
Children will have follow-up visits on days 3, 7, 28 and 180. One teaspoon of blood will be collected on days 0 and 28.
Read the detailed description
This study will be divided into two cohorts, by age, with separate study designs. The first cohort will include children 9 through 11 months of age. The second cohort will comprise children 15 through 23 months of age. The purpose of this detailed evaluation of safety and immunogenicity is to assess the reactogenicity of the vaccine and the immune responses to Vi-TCV. Serum specimens will be collected from all participants on study day 0 (before vaccination) and on post-vaccination study day 28 to quantify anti-Vi and anti-tetanus toxoid antibodies. All children will have an additional 0.5 mL of blood collected on study day 0 before study vaccination to test for the presence of malaria parasitemia at baseline.
Children 9 through 11 months of age in the Ouagadougou study area will be eligible for the first age cohort, which will be a double-blind, individually randomized, controlled trial. Up to 100 children in this cohort will be randomized in a 1:1 ratio to receive Vi-TCV (Group 1) or IPV (Group 2). Participants will be unaware of which study vaccine, Vi-TCV or IPV, is received. Vi-TCV or IPV will be administered with measles-rubella vaccine (MR) and YFV, as per Burkina Faso Expanded Programme on Immunization (EPI) schedule. These 9 through 11-month-old children will have immunogenicity to Vi-TCV, YFV, and tetanus toxoid assessed on study days 0 and 28.
Children 15 through 23 months of age in the Ouagadougou study area will be eligible for the second cohort, a randomized study of the safety and immunogenicity of Vi-TCV when co-administered with routine Expanded Programme on Immunisation (EPI) vaccines (MAV and MR) or given alone, and MAV immunogenicity when co-adminstered or given alone. Participants in this cohort (up to 150) will be randomized 1:1:1 to one of three treatment groups, as follows. The first group of participants (Group A) will receive Vi-TCV and IPV at study day 0, with a subsequent dose of MAV at study day 28; the second group of participants (Group B) will receive MAV and Vi-TCV at study day 0; the third group (Group C) will receive MAV and IPV at study day 0. All children will receive MR at study day 0. Cohort 1 will be unblinded on day 28 for safety and follow-up and to ensure MAV receipt in Group A. These 15 through 23-month-old children will have antibody to meningococcal A vaccine, anti-Vi antibody, and tetanus toxoid antibody assessed on study days 0 and 28.
Participants in both cohorts will have home or clinic visits on days 3 and 7 following vaccination for solicitation of local and systemic adverse events. Non-serious adverse events will be assessed up until the study day 28 visit. Serious adverse events will be captured throughout study follow-up and actively during the study day 180 visit.
- Conditions
- Typhoid
- Being tested
- Vi-Typhoid Conjugate Vaccine (Vi-TCV), Inactivated Poliovirus Vaccine (IPV)
- Keywords
- Typhoid in Burkina Faso, Typhoid Conjugate 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-Typhoid Conjugate Vaccine (Vi-TCV)Biological
Single 0.5-ml intramuscular injection
Inactivated Poliovirus Vaccine (IPV)Biological
Single 0.5-ml intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Vi-Typhoid Conjugate Vaccine (Vi-TCV) | Experimental | Children will receive a single 0.5-ml dose of Vi-TCV administered by the intramuscular route. Receives: Biological: Vi-Typhoid Conjugate Vaccine (Vi-TCV) |
| Inactivated Poliovirus Vaccine (IPV) | Active comparator | Children will receive a single 0.5-ml dose of Inactivated Poliovirus Vaccine (IPV) by the intramuscular route. Receives: Biological: Inactivated Poliovirus Vaccine (IPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Vi-TCV After 7 Days
The proportion of participants who develop adverse events detected in the first 7 days after vaccination.
Measured: Within 7 days after vaccination
Safety of Vi-TCV After 6 Months
The proportion of participants who experience serious adverse events within 6 months of vaccination in all participants.
Measured: Within 6 months after vaccination
Safety of Vi-TCV After 28 Days
The proportion of participants who experience other non-serious adverse events up to 28 days following vaccination, in a subset of participants.
Measured: Within 28 days after vaccination
Secondary outcomes (4)
Noninterference Vi-TCV with Yellow Fever Vaccine
The immunogenicity of YF when given with and without Vi-TCV, measured by yellow fever plaque reduction neutralization test at study days 0 and 28 among children in cohort 1, groups 1 and 2.
Measured: At days 0 and 28
Noninterference of Vi-TCV with Meningitis A Vaccine
The immunogenicity of MAV when given with and without Vi-TCV, measured by serum bactericidal antibody at study days 0 and 28 among children in cohort 2, groups 4 and 5.
Measured: At days 0 and 28
Noninterference of Yellow Fever Vaccine with Vi-TCV
The immunogenicity of Vi-TCV when given with YF, measured by ELISA for anti-Vi percent seroconversion (>4-fold increase in geometric mean titer (GMT)) and GMT at study days 0 and 28 among children in cohort 1, groups 1 and 2.
Measured: At days 0 and 28
Noninterference of Meningitis A Vaccine with Vi-TCV
The immunogenicity of Vi-TCV when given with and without MAV, measured by ELISA for anti-Vi percent seroconversion (>4-fold increase in GMT) and GMT at study days 0 and 28 among children in cohort 2, groups 3 and 4.
Measured: At days 0 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start3 Dec 2018
- Primary completion22 Aug 2019
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TyphoidStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Groupe de Recherche Action en Sante
- Responsible party
- Principal investigator, Matthew Laurens, University of Maryland, Baltimore
- Investigators
- Laurens Matthew, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614533
- Sponsor's protocol ID
- HP-00081030
- Status last verified
- May 2025
- First submitted
- 11 Jul 2018
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laurens MB, Sirima SB, Rotrosen ET, Siribie M, Tiono A, Ouedraogo A, Liang Y, Jamka LP, Kotloff KL, Neuzil KM. A Phase II, Randomized, Double-blind, Controlled Safety and Immunogenicity Trial of Typhoid Conjugate Vaccine in Children Under 2 Years of Age in Ouagadougou, Burkina Faso: A Methods Paper. Clin Infect Dis. 2019 Mar 7;68(Suppl 2):S59-S66. doi: 10.1093/cid/ciy1104.
PubMed 30845330
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Controlled Trial of the Safety and Immunogenicity of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso
- ClinicalTrials.gov ID
- NCT03614533
- Acronym / sponsor ID
- HP-00081030
- Conditions
- Typhoid
- Keywords
- Typhoid in Burkina Faso, Typhoid Conjugate Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Groupe de Recherche Action en Sante
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 3 Aug 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.
Typhoid fever is an illness that may cause mild effects in children, such as fever and feeling tired, or it may cause serious effects-- even death. A new typhoid vaccine has recently been recommended by the World Health Organization (WHO) to prevent typhoid in children. But this new typhoid vaccine has not been tested with all of the vaccines given to children in Burkina Faso. The investigators want to look at this new vaccine, and study how safe it is in children in Burkina Faso and how their immune systems respond to the vaccine when given with other vaccines, such as yellow fever and meningitis A vaccines.
The investigators plan to vaccinate 100 children between the ages of 9-11 months, and 150 children between the ages of 15 months and 2 years, in Ouagadougou, Burkina Faso, with either the typhoid vaccine or a vaccine against another illness called polio.
Children will have follow-up visits on days 3, 7, 28 and 180. One teaspoon of blood will be collected on days 0 and 28.
Detailed description
This study will be divided into two cohorts, by age, with separate study designs. The first cohort will include children 9 through 11 months of age. The second cohort will comprise children 15 through 23 months of age. The purpose of this detailed evaluation of safety and immunogenicity is to assess the reactogenicity of the vaccine and the immune responses to Vi-TCV. Serum specimens will be collected from all participants on study day 0 (before vaccination) and on post-vaccination study day 28 to quantify anti-Vi and anti-tetanus toxoid antibodies. All children will have an additional 0.5 mL of blood collected on study day 0 before study vaccination to test for the presence of malaria parasitemia at baseline.
Children 9 through 11 months of age in the Ouagadougou study area will be eligible for the first age cohort, which will be a double-blind, individually randomized, controlled trial. Up to 100 children in this cohort will be randomized in a 1:1 ratio to receive Vi-TCV (Group 1) or IPV (Group 2). Participants will be unaware of which study vaccine, Vi-TCV or IPV, is received. Vi-TCV or IPV will be administered with measles-rubella vaccine (MR) and YFV, as per Burkina Faso Expanded Programme on Immunization (EPI) schedule. These 9 through 11-month-old children will have immunogenicity to Vi-TCV, YFV, and tetanus toxoid assessed on study days 0 and 28.
Children 15 through 23 months of age in the Ouagadougou study area will be eligible for the second cohort, a randomized study of the safety and immunogenicity of Vi-TCV when co-administered with routine Expanded Programme on Immunisation (EPI) vaccines (MAV and MR) or given alone, and MAV immunogenicity when co-adminstered or given alone. Participants in this cohort (up to 150) will be randomized 1:1:1 to one of three treatment groups, as follows. The first group of participants (Group A) will receive Vi-TCV and IPV at study day 0, with a subsequent dose of MAV at study day 28; the second group of participants (Group B) will receive MAV and Vi-TCV at study day 0; the third group (Group C) will receive MAV and IPV at study day 0. All children will receive MR at study day 0. Cohort 1 will be unblinded on day 28 for safety and follow-up and to ensure MAV receipt in Group A. These 15 through 23-month-old children will have antibody to meningococcal A vaccine, anti-Vi antibody, and tetanus toxoid antibody assessed on study days 0 and 28.
Participants in both cohorts will have home or clinic visits on days 3 and 7 following vaccination for solicitation of local and systemic adverse events. Non-serious adverse events will be assessed up until the study day 28 visit. Serious adverse events will be captured throughout study follow-up and actively during the study day 180 visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vi-Typhoid Conjugate Vaccine (Vi-TCV) | Experimental | Biological: Vi-Typhoid Conjugate Vaccine (Vi-TCV)Children will receive a single 0.5-ml dose of Vi-TCV administered by the intramuscular route. |
| Inactivated Poliovirus Vaccine (IPV) | Active comparator | Biological: Inactivated Poliovirus Vaccine (IPV)Children will receive a single 0.5-ml dose of Inactivated Poliovirus Vaccine (IPV) by the intramuscular route. |
Who may qualify
- Ages
- 9 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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-Typhoid Conjugate Vaccine (Vi-TCV)Single 0.5-ml intramuscular injection | Biological | Vi-Typhoid Conjugate Vaccine (Vi-TCV) |
| Inactivated Poliovirus Vaccine (IPV)Single 0.5-ml intramuscular injection | Biological | Inactivated Poliovirus Vaccine (IPV) |
Primary outcome
Safety of Vi-TCV After 7 Days
Time frame: Within 7 days after vaccination
The proportion of participants who develop adverse events detected in the first 7 days after vaccination.
Safety of Vi-TCV After 6 Months
Time frame: Within 6 months after vaccination
The proportion of participants who experience serious adverse events within 6 months of vaccination in all participants.
Safety of Vi-TCV After 28 Days
Time frame: Within 28 days after vaccination
The proportion of participants who experience other non-serious adverse events up to 28 days following vaccination, in a subset of participants.
4 secondary outcomes
Noninterference Vi-TCV with Yellow Fever Vaccine
Time frame: At days 0 and 28
Noninterference of Vi-TCV with Meningitis A Vaccine
Time frame: At days 0 and 28
Noninterference of Yellow Fever Vaccine with Vi-TCV
Time frame: At days 0 and 28
Noninterference of Meningitis A Vaccine with Vi-TCV
Time frame: At days 0 and 28
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 30 May 2025.
- Derived from this study: PubMed 30845330Laurens MB, Sirima SB, Rotrosen ET, Siribie M, Tiono A, Ouedraogo A, Liang Y, Jamka LP, Kotloff KL, Neuzil KM. A Phase II, Randomized, Double-blind, Controlled Safety and Immunogenicity Trial of Typhoid Conjugate Vaccine in Children Under 2 Years of Age in Ouagadougou, Burkina Faso: A Methods Paper. Clin Infect Dis. 2019 Mar 7;68(Suppl 2):S59-S66. doi: 10.1093/cid/ciy1104.
- 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.
Laurens Matthew, MD principal investigator
University of Maryland, Baltimore
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-Typhoid Conjugate Vaccine (Vi-TCV) and Inactivated Poliovirus Vaccine (IPV) in people with Typhoid, run by University of Maryland, Baltimore at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 May 2025. 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 Burkina Faso. 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?
Safety of Vi-TCV After 7 Days (time frame: Within 7 days after vaccination). The study lists 3 primary outcomes in all. 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 NCT03614533, which also lists 1 linked publication.
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 30 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.