Back to resultsSafety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Primary Purpose
Typhoid Fever
Status
Completed
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
Vi-CRM197 vaccine
Pneumococcal conjugate vaccine
Vi Polysaccharide (PS) vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Typhoid Fever
Eligibility 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.
Sites / Locations
- Research Institute for Tropical Medicine (RITM)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Vi-CRM, Older infants
PNC13, Older infants
Vi-CRM, Infants
PNC13, Infants
Vi-CRM, Children
Vi-PS, Children
Arm Description
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
Outcomes
Primary Outcome Measures
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Anti-Vi ELISA GMC
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01437267
Brief Title
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid Fever
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vi-CRM, Older infants
Arm Type
Experimental
Arm Description
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Arm Title
PNC13, Older infants
Arm Type
Active Comparator
Arm Description
Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
Arm Title
Vi-CRM, Infants
Arm Type
Experimental
Arm Description
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
Arm Title
PNC13, Infants
Arm Type
Active Comparator
Arm Description
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
Arm Title
Vi-CRM, Children
Arm Type
Experimental
Arm Description
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Arm Title
Vi-PS, Children
Arm Type
Active Comparator
Arm Description
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Vi-CRM197 vaccine
Intervention Type
Biological
Intervention Name(s)
Pneumococcal conjugate vaccine
Other Intervention Name(s)
Prevenar 13
Intervention Type
Biological
Intervention Name(s)
Vi Polysaccharide (PS) vaccine
Other Intervention Name(s)
Typherix
Primary Outcome Measure Information:
Title
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
Time Frame
At 28 days after last vaccination as compared to baseline
Title
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
Time Frame
At 6 months after last vaccination as compared to baseline
Title
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Time Frame
At 28 days after last vaccination
Title
Anti-Vi ELISA GMC
Time Frame
At 6 months after last vaccination
Secondary Outcome Measure Information:
Title
Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination
Description
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)
Time Frame
During the 7-day follow-up period after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Rosario Z Capeding, MD
Organizational Affiliation
Research Institute for Tropical Medicine (RITM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute for Tropical Medicine (RITM)
City
Alabang, Muntinlupa City
ZIP/Postal Code
1781
Country
Philippines
12. IPD Sharing Statement
Citations:
PubMed Identifier
24290843
Citation
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 typhoid fever in adults, children, and infants in south and southeast Asia: results from two randomised, observer-blind, age de-escalation, phase 2 trials. Lancet Infect Dis. 2014 Feb;14(2):119-29. doi: 10.1016/S1473-3099(13)70241-X. Epub 2013 Nov 28.
Results Reference
result
Learn more about this trial
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
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