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

Typhoid Fever Clinical Trial

Official title:

A Phase 2, Randomized, Controlled, Observer Blind, Single Center Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Children, Older Infants and Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437267
• Other study ID #: H01_05TP
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2011
• Last updated: March 5, 2014
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Typhoid Fever

Intervention

Biological:
• Vi-CRM197 vaccine

• Pneumococcal conjugate vaccine

• Vi Polysaccharide (PS) vaccine

Locations

Country	Name	City	State
Philippines	Research Institute for Tropical Medicine (RITM)	Alabang, Muntinlupa City

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

Bhutta ZA, Capeding MR, Bavdekar A, Marchetti E, Ariff S, Soofi SB, Anemona A, Habib MA, Alberto E, Juvekar S, Khan RM, Marhaba R, Ali N, Malubay N, Kawade A, Saul A, Martin LB, Podda A. Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer		At 6 months after last vaccination as compared to baseline	No
Primary	Anti-Vi ELISA Geometric Mean Concentration (GMC)		At 28 days after last vaccination	No
Primary	Anti-Vi ELISA GMC		At 6 months after last vaccination	No
Secondary	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)	During the 7-day follow-up period after vaccination	Yes