Phase 2
N=120
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Typhoid Fever
Bottom Line
View on ClinicalTrials.gov: NCT01437267 ↗Enrolled (actual)
120
Serious AEs
1.7%
Results posted
Apr 2014
Primary outcome: Primary: Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer — 100; 100; 100; 11 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vi-CRM197 vaccine (Biological); Pneumococcal conjugate vaccine (Biological); Vi Polysaccharide (PS) vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer |
100; 100; 100; 11; 100; 10 | — |
| PRIMARY Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer |
90; 95; 70; 11; 70; 5 | — |
| PRIMARY Anti-Vi ELISA Geometric Mean Concentration (GMC) |
255; 107; 129; 3.79; 103; 5.05 | — |
| PRIMARY Anti-Vi ELISA GMC |
51; 45; 21; 3.69; 21; 2.64 | — |
| SECONDARY Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination |
11; 10; 12; 17; 20; 19 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01437267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.