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

Novartis

Status and phase: Completed; Phase 2

Conditions: Typhoid Fever

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437267

H01_05TP

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 6 weeks to 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 6 patient groups

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

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