Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| INV 030857 | Other Grant/Funding Number | Gates Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Groupe de Recherche Action en Sante | OTHER |
Not provided
Not provided
Not provided
Not provided
This study evaluated the persistence of immunity following primary typhoid conjugate vaccination in early childhood and assessed the immunogenicity and safety of a booster dose administered 5-6 years later. Children previously enrolled in a Phase 2 randomized clinical trial of Vi-tetanus toxoid conjugate vaccine (Vi-TT) were re-enrolled at 6-7 years of age. Participants who previously received Vi-TT received a booster dose of Vi-CRM, while control participants received their first TCV dose.
Anti-Vi IgG antibody responses were measured at baseline and 28 days post-vaccination. Safety was assessed through solicited and unsolicited adverse events. This study provides data on durability of TCV immunity and the potential role of booster dosing in endemic settings.
This prospective, open-label interventional study followed children previously enrolled in a Phase 2 randomized controlled trial of Vi-TT administered in infancy. Approximately 5-6 years later, participants were re-contacted and assigned to receive either a booster TCV dose (Vi-CRM) or a first TCV dose depending on prior vaccination status.
Immunogenicity was assessed using anti-Vi IgG ELISA assays at baseline and 28 days post-vaccination. Safety outcomes included solicited and unsolicited adverse events and serious adverse events. The study was conducted at a single clinical site in Ouagadougou, Burkina Faso.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| typhoid conjugate vaccine (TCV) | Experimental | Received one intramuscular dose of Vi-CRM (TYPHIBEV®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM | Biological | Typhoid conjugate vaccine: Vi capsular polysaccharide conjugated to CRM197 carrier protein, administered as 0.5mL intramuscularly |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Vi IgG Antibody Response (Immunogenicity) | Geometric Mean Titers (GMT) and fold-rise in anti-Vi IgG | Baseline (Day 0) and Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | Proportion of participants achieving ≥4-fold increase in anti-Vi IgG | Day 28 |
| Solicited adverse events | Local and systemic adverse events within 7 days post-vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schiphra Protestant Hospital | Ouagadougou | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30845330 | Background | 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. | |
| 33176205 |
Not provided
Not provided
Individual participant data will be available, after de-identification, via the Vivli platform upon approved request.
Upon study publication and for the subsequent 24 months.
Persons who submit an approved request via the Vivli platform online will be able to access individual participant data after de-identification.
Not provided
Participants vaccinated previously at age 9-23 months with either typhoid conjugate vaccine (Vi-TT typhoid conjugate vaccine) or control vaccine (inactivated polio vaccine) as part of a clinical trial receive a dose of typhoid conjugate vaccine (Vi-CRM typhoid conjugate vaccine) as a first or second typhoid conjugate vaccine dose, respectively.
Not provided
Not provided
Not provided
Not provided
| Days 0-7 |
| Unsolicited adverse events | Any non-solicited adverse events | Days 0-28 |
| Serious adverse events | Any serious adverse events | Days 0-28 |
| Background |
| Sirima SB, Ouedraogo A, Barry N, Siribie M, Tiono AB, Nebie I, Konate AT, Berges GD, Diarra A, Ouedraogo M, Soulama I, Hema A, Datta S, Liang Y, Rotrosen ET, Tracy JK, Jamka LP, Neuzil KM, Laurens MB. Safety and immunogenicity of co-administration of meningococcal type A and measles-rubella vaccines with typhoid conjugate vaccine in children aged 15-23 months in Burkina Faso. Int J Infect Dis. 2021 Jan;102:517-523. doi: 10.1016/j.ijid.2020.10.103. Epub 2020 Nov 8. |
| 34082090 | Background | Sirima SB, Ouedraogo A, Barry N, Siribie M, Tiono A, Nebie I, Konate A, Berges GD, Diarra A, Ouedraogo M, Bougouma EC, Soulama I, Hema A, Datta S, Liang Y, Rotrosen ET, Tracy JK, Jamka LP, Oshinsky JJ, Pasetti MF, Neuzil KM, Laurens MB. Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial. Int J Infect Dis. 2021 Jul;108:465-472. doi: 10.1016/j.ijid.2021.05.061. Epub 2021 Jun 1. |
| 37589596 | Background | Ouedraogo A, Diarra A, Nebie I, Barry N, Kabore JM, Tiono AB, Datta S, Liang Y, Mayo I, Oshinsky JJ, Tracy JK, Girmay T, Pasetti MF, Jamka LP, Neuzil KM, Sirima SB, Laurens MB. Durable Anti-Vi IgG and IgA Antibody Responses in 15-Month-Old Children Vaccinated With Typhoid Conjugate Vaccine in Burkina Faso. J Pediatric Infect Dis Soc. 2023 Sep 27;12(9):513-518. doi: 10.1093/jpids/piad058. |
| Result | Sawadogo JW, Hema A, Diarra A, Kabore JM, Hien D, Kouraogo L, Zou AR, Ouedraogo AZ, Tiono AB, Datta S, Pasetti MF, Neuzil KM, Sirima SB, Ouedraogo A, Laurens MB#. Immunogenicity and tolerability of booster typhoid conjugate vaccine (TCV) five to six years after initial dose in Burkinabe children. medRxiv [Preprint]. 2026 Apr 21. doi:10.64898/2026.04.19.26351224. |
| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided