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

Phase 2

Completed

• Conditions: Typhoid Fever
• Interventions: Biological: Vi-CRM197 vaccine; Biological: Pneumococcal conjugate vaccine; Biological: Vi Polysaccharide (PS) vaccine

• Registration Number: NCT01437267
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Study Start: 2011-10
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-03
• Results First Submitted: 2014-03-05
• Results First Submitted QC: 2014-03-05
• Last Update Submitted: 2014-03-05
• Results First Posted: 2014-04-10
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vi-CRM, Older infants	Vi-CRM197 vaccine	Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
PNC13, Older infants	Pneumococcal conjugate vaccine	Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
Vi-CRM, Infants	Vi-CRM197 vaccine	Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
PNC13, Infants	Pneumococcal conjugate vaccine	Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
Vi-CRM, Children	Vi-CRM197 vaccine	Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Vi-PS, Children	Pneumococcal conjugate vaccine	Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
Vi-PS, Children	Vi Polysaccharide (PS) vaccine	Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine

Primary Outcome Measures

Name	Time	Method
Anti-Vi ELISA GMC	At 6 months after last vaccination
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer	At 6 months after last vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer	At 28 days after last vaccination as compared to baseline
Anti-Vi ELISA Geometric Mean Concentration (GMC)	At 28 days after last vaccination

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination	During the 7-day follow-up period after 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)

Trial Locations

Locations (1)

Research Institute for Tropical Medicine (RITM); 🇵🇭 Alabang, Muntinlupa City, Philippines