Back to resultsSafety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Primary Purpose
Typhoid Fever
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vi-CRM197 vaccine
Vi Polysaccharide (PS) vaccine
Pneumococcal conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Typhoid Fever
Eligibility 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.
Sites / Locations
- K.E.M. Hospital Research Centre
- The Aga Khan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Vi-CRM, Adults
Vi-PS, Adults
Vi-CRM, Children
Vi-PS, Children
Vi-CRM, Older infants
PNC13, Older infants
Vi-CRM, Infants
PNC13, Infants
Arm Description
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide 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
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
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: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site.
Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever.
Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01229176
Brief Title
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Official Title
A Phase 2a, Randomized, Controlled, Observer Blind, Age De-Escalation, Multicenter and Multinational Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 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 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.
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
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vi-CRM, Adults
Arm Type
Experimental
Arm Description
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
Arm Title
Vi-PS, Adults
Arm Type
Active Comparator
Arm Description
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide 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
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
Intervention Type
Biological
Intervention Name(s)
Vi-CRM197 vaccine
Intervention Type
Biological
Intervention Name(s)
Vi Polysaccharide (PS) vaccine
Other Intervention Name(s)
Typherix
Intervention Type
Biological
Intervention Name(s)
Pneumococcal conjugate vaccine
Other Intervention Name(s)
Prevenar 13
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: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site.
Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever.
Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants).
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
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NVGH
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
K.E.M. Hospital Research Centre
City
Pune
State/Province
Maharastra
ZIP/Postal Code
411011
Country
India
Facility Name
The Aga Khan University Hospital
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
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 Adults, Children, Older Infants and Infants
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