Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants

Novartis120 enrolled

Overview

This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Typhoid Fever

Interventions

Vi-CRM197 vaccineBIOLOGICAL

Pneumococcal conjugate vaccineBIOLOGICAL

Vi Polysaccharide (PS) vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 59 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment). * Written informed consent will be obtained by the parents/ guardians before enrollment into the trial. * Infants who have been vaccinated with BCG and HBV at birth and OPV at any time since birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.

Locations (1)

Research Institute for Tropical Medicine (RITM)

Alabang, Muntinlupa City, Philippines

Outcomes

Primary Outcomes

Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer

Time frame: At 28 days after last vaccination as compared to baseline

Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer

Time frame: At 6 months after last vaccination as compared to baseline

Anti-Vi ELISA Geometric Mean Concentration (GMC)

Time frame: At 28 days after last vaccination

Anti-Vi ELISA GMC

Time frame: At 6 months after last vaccination

Secondary Outcomes

Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination

Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)

Time frame: During the 7-day follow-up period after vaccination

Data from ClinicalTrials.gov

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