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

NCT01229176 | Completed Phase 2 Results DMC

• 1 other identifier: H01_02TP
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

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.

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  During the 7-day follow-up period after vaccination

Study Arms (8)

Vi-CRM, Adults

EXPERIMENTAL

Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine

Biological: Vi-CRM197 vaccine

Vi-PS, Adults

ACTIVE COMPARATOR

Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine

Biological: Vi Polysaccharide (PS) vaccine

Vi-CRM, Children

EXPERIMENTAL

Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine

Biological: Vi-CRM197 vaccine

Vi-PS, Children

ACTIVE COMPARATOR

Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine

Biological: Vi Polysaccharide (PS) vaccine; Biological: Pneumococcal conjugate vaccine

Vi-CRM, Older infants

EXPERIMENTAL

Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine

Biological: Vi-CRM197 vaccine

PNC13, Older infants

ACTIVE COMPARATOR

Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine

Biological: Pneumococcal conjugate vaccine

Vi-CRM, Infants

EXPERIMENTAL

Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine

Biological: Vi-CRM197 vaccine

PNC13, Infants

ACTIVE COMPARATOR

Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine

Biological: Pneumococcal conjugate vaccine

Interventions

Vi-CRM197 vaccine BIOLOGICAL

Vi-CRM, Adults; Vi-CRM, Children; Vi-CRM, Infants; Vi-CRM, Older infants

Vi Polysaccharide (PS) vaccine BIOLOGICAL

Also known as: Typherix

Vi-PS, Adults; Vi-PS, Children

Pneumococcal conjugate vaccine BIOLOGICAL

Also known as: Prevenar 13

PNC13, Infants; PNC13, Older infants; Vi-PS, Children

Eligibility Criteria

• Age: 6 Weeks - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

K.E.M. Hospital Research Centre

Pune, Maharashtra, 411011, India

Location

The Aga Khan University Hospital

Karachi, 74800, Pakistan

Location

Related 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 typhoid fever in adults, children, and infants in south and southeast Asia: results from two randomised, observer-blind, age de-escalation, phase 2 trials. Lancet Infect Dis. 2014 Feb;14(2):119-29. doi: 10.1016/S1473-3099(13)70241-X. Epub 2013 Nov 28.

  PMID: 24290843 RESULT

MeSH Terms

Conditions

Typhoid Fever

Interventions

Polysaccharides; Vaccines; Pneumococcal Vaccines; 13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Carbohydrates; Biological Products; Complex Mixtures; Streptococcal Vaccines; Bacterial Vaccines

Results Point of Contact

• Title: Dr. Audino Podda
• Organization: Novartis Vaccines Institute for Global Health

audino.podda@novartis.com

+39 0577 243496

Study Officials

• NVGH

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 27, 2010
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 1, 2014
• Results First Posted: April 10, 2014

Record last verified: 2014-04

Locations

PA (1); IN (1)