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

Typhoid Fever Clinical Trial

Official title:

A Phase 2a, Randomized, Controlled, Observer Blind, Age De-Escalation, Multicenter and Multinational Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229176
• Other study ID #: H01_02TP
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2010
• Last updated: April 11, 2014
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of HealthIndia: Drugs Controller General of India
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 45 Years

Eligibility

Main eligibility criteria:

• Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), 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 all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial.

• Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial.

• Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV 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: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Typhoid Fever

Intervention

Biological:
• Vi-CRM197 vaccine

• Vi Polysaccharide (PS) vaccine

• Pneumococcal conjugate vaccine

Locations

Country	Name	City	State
India	K.E.M. Hospital Research Centre	Pune	Maharastra
Pakistan	The Aga Khan University Hospital	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

India,  Pakistan, 

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: 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).	During the 7-day follow-up period after vaccination	Yes