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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01437267
Other study ID # H01_05TP
Secondary ID
Status Completed
Phase Phase 2
First received September 19, 2011
Last updated March 5, 2014
Start date October 2011
Est. completion date August 2012

Study information

Verified date March 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 59 Months
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Vi-CRM197 vaccine

Pneumococcal conjugate vaccine

Vi Polysaccharide (PS) vaccine


Locations

Country Name City State
Philippines Research Institute for Tropical Medicine (RITM) Alabang, Muntinlupa City

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Philippines, 

References & 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer At 6 months after last vaccination as compared to baseline No
Primary Anti-Vi ELISA Geometric Mean Concentration (GMC) At 28 days after last vaccination No
Primary Anti-Vi ELISA GMC At 6 months after last vaccination No
Secondary Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group) During the 7-day follow-up period after vaccination Yes
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