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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Typhoid Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Vi-CRM, Adults

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

Group Type EXPERIMENTAL

Vi-CRM197 vaccine

Intervention Type BIOLOGICAL

Vi-PS, Adults

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

Group Type ACTIVE_COMPARATOR

Vi Polysaccharide (PS) vaccine

Intervention Type BIOLOGICAL

Vi-CRM, Children

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

Group Type EXPERIMENTAL

Vi-CRM197 vaccine

Intervention Type BIOLOGICAL

Vi-PS, Children

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

Group Type ACTIVE_COMPARATOR

Vi Polysaccharide (PS) vaccine

Intervention Type BIOLOGICAL

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Vi-CRM, Older infants

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

Group Type EXPERIMENTAL

Vi-CRM197 vaccine

Intervention Type BIOLOGICAL

PNC13, Older infants

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

Group Type ACTIVE_COMPARATOR

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Vi-CRM, Infants

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

Group Type EXPERIMENTAL

Vi-CRM197 vaccine

Intervention Type BIOLOGICAL

PNC13, Infants

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

Group Type ACTIVE_COMPARATOR

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Interventions

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Vi-CRM197 vaccine

Intervention Type BIOLOGICAL

Vi Polysaccharide (PS) vaccine

Intervention Type BIOLOGICAL

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Typherix Prevenar 13

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes