Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso

NCT03614533 | Completed Phase 2

• 1 other identifier: HP-00081030
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Typhoid

Keywords

Typhoid in Burkina Faso; Typhoid Conjugate Vaccine

Outcome Measures

Primary Outcomes (3)

• Safety of Vi-TCV After 7 Days

  The proportion of participants who develop adverse events detected in the first 7 days after vaccination.

  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.

  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.

  Within 28 days after vaccination

Secondary Outcomes (4)

• Noninterference Vi-TCV with Yellow Fever Vaccine

  At days 0 and 28

• Noninterference of Vi-TCV with Meningitis A Vaccine

  At days 0 and 28

• Noninterference of Yellow Fever Vaccine with Vi-TCV

  At days 0 and 28

• Noninterference of Meningitis A Vaccine with Vi-TCV

  At days 0 and 28

Study Arms (2)

Vi-Typhoid Conjugate Vaccine (Vi-TCV)

EXPERIMENTAL

Children will receive a single 0.5-ml dose of Vi-TCV administered by the intramuscular route.

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.

Biological: Inactivated Poliovirus Vaccine (IPV)

Interventions

Vi-Typhoid Conjugate Vaccine (Vi-TCV) BIOLOGICAL

Single 0.5-ml intramuscular injection

Vi-Typhoid Conjugate Vaccine (Vi-TCV)

Inactivated Poliovirus Vaccine (IPV) BIOLOGICAL

Single 0.5-ml intramuscular injection

Inactivated Poliovirus Vaccine (IPV)

Eligibility Criteria

• Age: 9 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Reported fever within 24 hours before vaccination.
• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Bill and Melinda Gates Foundation: collaborator
• Groupe de Recherche Action en Sante: collaborator

Study Sites (1)

Groupe de Recherche Action en Santé (GRAS)

Ouagadougou, Burkina Faso

Location

Related Publications (1)

• 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.

  PMID: 30845330 DERIVED

MeSH Terms

Conditions

Typhoid Fever

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Laurens Matthew, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 3, 2018
• Study Start: December 3, 2018
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)