Clinical trial NCT01229176: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Typhoid Fever
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
timeFrame: At 28 days after last vaccination as compared to baseline
measure: Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
timeFrame: At 6 months after last vaccination as compared to baseline
measure: Anti-Vi ELISA Geometric Mean Concentration (GMC)
timeFrame: At 28 days after last vaccination
measure: Anti-Vi ELISA GMC
timeFrame: At 6 months after last vaccination
Secondary outcomes:
measure: Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination
timeFrame: During the 7-day follow-up period after vaccination
Other outcomes:
Locations:
city: Pune
country: India
facility: K.E.M. Hospital Research Centre
state: Maharastra
city: Karachi
country: Pakistan
facility: The Aga Khan University Hospital
Study officials:
affiliation: Novartis
name: NVGH
role: STUDY_DIRECTOR
References:
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.