Immunogenicity and Safety of Typhoid Conjugate Vaccine in Healthy Indian Subjects: A Randomized, Active-controlled, Comparative Clinical Trial.
Indian Pediatr
; 57(7): 625-630, 2020 07 15.
Article
em En
| MEDLINE
| ID: mdl-32727938
ABSTRACT
OBJECTIVE:
To compare the immunogenicity and safety of an investigational typhoid Vi conjugate vaccine (Test TCV) with a marketed typhoid Vi conjugate vaccine (Comparator TCV).DESIGN:
Randomized, controlled trial.SETTING:
Tertiary care and multispecialty hospitals.PARTICIPANTS:
240 healthy subjects of 6 months to 45 years. Pediatric (<18 years) subjects were enrolled after day 21 safety assessment of adult subjects. INTERVENTION Participants received a single-dose of test TCV or comparator TCV at baseline and were followed up for 6 weeks post-vaccination. MAIN OUTCOMEMEASURE:
Primary variable was to demonstrate non-inferiority of the test TCV with the comparator TCV for seroconversion post-vaccination (³4-fold rise in antibody titre). Secondary variables were seroconversion in the adult and pediatric cohorts, and geometric mean titre of antibodies while the safety was based on reported adverse events.RESULTS:
A total of 117 subjects (Adult-58, Pediatric-59) and 119 subjects (Adult-60, Pediatric-59) in test and comparator group, respectively completed the study. The seroconversion rate with test TCV (overall-94.8%, adult-96.6% and pediatric-93.1%) was non-inferior to comparator TCV (overall-91.6%, adult-91.7% and pediatric-91.5%). The geometric mean titres of antibodies (EU/mL) at baseline (test TCV overall-7.6, adult-10.0, and pediatric-5.7; and comparator TCV overall-8.0, adult-12.0, and pediatric-5.3) and at end of study (test TCV overall-1121.0, adult-1411.0 and pediatric-891.1; and comparator TCV overall-1104.0, adult-1199.0 and pediatric-1014.0) were also comparable between the groups (P>0.05 for all). The most common adverse event was injection-site pain followed by fever in both the groups.CONCLUSIONS:
The immunogenicity and safety of test TCV is comparable to already marketed comparator TCV.
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Base de dados:
MEDLINE
Assunto principal:
Febre Tifoide
/
Vacinas Tíficas-Paratíficas
/
Vacinas Conjugadas
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article