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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-08-31

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 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.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Vi Polysaccharide (PS) vaccine

Intervention Type BIOLOGICAL

Interventions

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Vi-CRM197 vaccine

Intervention Type BIOLOGICAL

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Vi Polysaccharide (PS) vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Prevenar 13 Typherix

Eligibility Criteria

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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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes