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

PHRR121206-000029

Protocol No. H01_05TP

Unspecified

A Phase 2, Randomized, Controlled, Observer Blind, Single Center Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine against S. Typhi in Children, Older Infants and Infants

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.

Start Date Duration in Months Target Completion Date Actual Completion Date
2011-10-20 10 2012-08-20 2012-08-09

Completed

Institution Classification Region LTO #
Novartis Vaccines Institute for Global Health Private Business Italy
Institution Region
Novartis Vaccines Institute for Global Health Italy
Name E-Mail Phone Number Postal Address
Leilani Sanchez, MD (Local contact to coordinate with NVGH) leilani_lee.sanchez@novartis.com +632 3687777 Novartis Healthcare Philippines, Inc. 5F Republic Glass Building, 196 Salcedo St. Legaspi Village, Makati City 1229, Philippines
Name E-Mail Phone Number Postal Address
Audino Podda, MD audino.podda@novartis.com +39 0577 243496 Novartis Vaccines Institute for Global Health (NVGH), Via Fiorentina, 1 - 53100 Siena, Italy
Name Expertise Affiliation
Maria Rosario Z. Capeding, MD Pediatric Infectious Disease Research Institute for Tropical Medicine
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
Research Institute for Tropical Medicine Department of Health Compound, FILINVEST Corporate City, Alabang, Muntinlupa City, 1781 Maria Rosario Z. Capeding, MD Pediatric Infectious Disease
Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board

Clinical Trial

Unspecified

Prevention of Typhoid Fever

To evaluate the immunogenicity profile as measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 28 days after vaccination ]

•Number of subjects reporting any post immunization reactions [ Time Frame: During the 7-day period after vaccination ] [ Designated as safety issue: Yes ] Solicited reactions collected during the 7-day period after vaccination are: Local Reactions Children: Pain, Erythema, Induration Infant groups: Tenderness, Erythema, Induration Systemic reactions Children: Lethargy, Irritability, Vomiting, Diarrhea, Loss of Appetite, Rash Infant groups: Lethargy, Irritability, Vomiting, Diarrhea, Loss of Appetite, Rash, Persistent Crying •Number of subjects reporting Adverse Events [ Time Frame: During the 28-day period after vaccination ] [ Designated as safety issue: Yes ] •Number of subjects reporting Serious Adverse Events (SAEs) [ Time Frame: During the 6-month period after last vaccination ] [ Designated as safety issue: Yes ]

Completed

  • Philippines

Protocol No. H01_05TP

Unspecified

Unspecified

0000-00-00

Protocol Code Number Protocol No. H01_05TP
Protocol Version Unspecified
Date of Protocol Version Unspecified

120

120

Unspecified

Unspecified

20 Oct 2011

•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.

Interventional

NVGH Vi-CRM197 vaccine

NVGH Vi-CRM197 is a glycoconjugated vaccine, based on chemical conjugation of the Vi polysaccharide with the CRM197 carrier protein.

None

Method of Allocation

Randomized

Masking or Blinding

Double Blind (Subject, Caregiver, Investigator, Ou

Masking Details

Unspecified

Control

Unspecified

Assignment

Parallel

Phase

Phase II

Purpose of the Study

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.

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

Unspecified

URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

Unspecified

Participant Flow

Unspecified

Adverse Events

Unspecified

Outcome Measures

Unspecified

Brief Summary

Unspecified

Utilization Utilization Info
Publication Includes publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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