Phase 2
Completed N=200
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Source: ClinicalTrials.gov NCT01229176 ↗Enrolled (actual)
200
Serious AEs
10.1%
Results posted
Apr 2014
Primary outcomePrimary: Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer — 100; 85; 100; 89 percentage of subjects
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.
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; 85; 100; 89; 95; 0 | — |
| PRIMARY Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer |
90; 81; 95; 68; 89; 6 | — |
| PRIMARY Anti-Vi ELISA Geometric Mean Concentration (GMC) |
153; 44; 136; 53; 109; 1.43 | — |
| PRIMARY Anti-Vi ELISA GMC |
59; 36; 23; 25; 22; 3.12 | — |
| SECONDARY Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination |
24; 27; 18; 17; 14; 19 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01229176). 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. Informational only — not medical advice.