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

Novartis

Status and phase: Completed; Phase 2

Conditions: Typhoid Fever

Treatments: Biological: Pneumococcal conjugate vaccine; Biological: Vi Polysaccharide (PS) vaccine; Biological: Vi-CRM197 vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229176

H01_02TP

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 6 weeks to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 8 patient groups

Vi-CRM, Adults

Experimental group

Description:

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

Treatment:

Biological: Vi-CRM197 vaccine

Vi-PS, Adults

Active Comparator group

Description:

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

Treatment:

Biological: Vi Polysaccharide (PS) vaccine

Vi-CRM, Children

Experimental group

Description:

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

Treatment:

Biological: Vi-CRM197 vaccine

Vi-PS, Children

Active Comparator group

Description:

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

Treatment:

Biological: Vi Polysaccharide (PS) vaccine

Biological: Pneumococcal conjugate vaccine

Vi-CRM, Older infants

Experimental group

Description:

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

Treatment:

Biological: Vi-CRM197 vaccine

PNC13, Older infants

Active Comparator group

Description:

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

Treatment:

Biological: Pneumococcal conjugate vaccine

Vi-CRM, Infants

Experimental group

Description:

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

Treatment:

Biological: Vi-CRM197 vaccine

PNC13, Infants

Active Comparator group

Description:

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

Treatment:

Biological: Pneumococcal conjugate vaccine