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

Phase 2

Completed

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

• Registration Number: NCT01229176
• Lead Sponsor: Novartis

Brief Summary

This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan 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: 2010-10-25
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Study Start: 2011-03
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2014-03-05
• Results First Submitted QC: 2014-03-05
• Status Verified: 2014-04
• Results First Posted: 2014-04-10
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vi-CRM, Adults	Vi-CRM197 vaccine	Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
Vi-CRM, Children	Vi-CRM197 vaccine	Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Vi-CRM, Older infants	Vi-CRM197 vaccine	Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Vi-PS, Adults	Vi Polysaccharide (PS) vaccine	Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide 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
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-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
PNC13, Older infants	Pneumococcal conjugate vaccine	Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine

Primary Outcome Measures

Name	Time	Method
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
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer	At 6 months after last vaccination as compared to baseline
Anti-Vi ELISA Geometric Mean Concentration (GMC)	At 28 days after last vaccination
Anti-Vi ELISA GMC	At 6 months 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: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site.; Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever.; Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants).

Trial Locations

Locations (2)

K.E.M. Hospital Research Centre; 🇮🇳 Pune, Maharastra, India

The Aga Khan University Hospital; 🇵🇰 Karachi, Pakistan