This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose. The study objectives are: I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT) II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose.
Subjects will be stratified according to age. The study procedure is as follows: Visit 1 (day-1 to -7): Screen participants by medical/medications history, physical examination, Vital signs, Urine pregnancy test (UPT) Visit 2 (day 0): Enroll, randomize and administer vaccine to eligible participants and assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments. Visit 3 (day 7): Check solicited adverse reaction 7 days post vaccination and Assess participant safety by physical examination and Vital signs Visit 4 (day 28): Assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments Visit 5 (day 84): Assess participant safety by physical examination and Vital signs Visit 6 (day 168): Assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments, and fill in study completion form in the absence of any safety concern. This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator. For retention: After vaccination, field health worker/designee will contact participant every day till Day 7 by physical visit or by phone call. Follow-up reminder calls will be done very frequently as per discretion of study staff until 24 weeks for all participant to assess participant safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
* Manufacturer: SK Bioscience Co., Ltd. * Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid * Dose: 25 µg of Vi polysaccharide/0.5 mL, presented in 3 mL multi-dose glass vial
* Manufacturer: Bharat Biotech * Ingredient: Purified Vi capsular polysaccharide of Salmonella Ty2 conjugated to tetanus toxoid protein * Dose: 0.5 ml
Nepalgunj medical college
Bānke, City- Nepalgunj, Nepal
B.P.Koirala Institute of Health Sciences
Rautahat, Dharan, Nepal
Dhulikhel Hospital
Kavre, Dhulikhel, Nepal
Kanti Children's Hospital
Kathmandu, Sukedhara, Nepal
Seroconversion rate1
Defined as a 4-fold increase of serum anti-Vi IgG antibody titer
Time frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0)
Geometric Mean Titers (GMT)1
Measurement of the Geometric Mean Titers (GMT) following 4 weeks after vaccination of three lots of Vi-DT
Time frame: 4 weeks after vaccination of Vi-DT
Geometric Mean Titers (GMT) 2
Measurement of the Geometric Mean Titers (GMT) following 4 weeks (28 days) and 24 weeks(168 days) after vaccination of Vi-DT (pooled)/ Typbar TCV®
Time frame: 4 weeks and 24 weeks after vaccination of Vi-DT(pooled)/ Typbar TCV®
Seroconversion rate 2
Defined as a 4-fold increase of serum anti-Vi IgG antibody titer
Time frame: 24 weeks (168 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0).
Seroconversion rate 3
Definded as a Seroconversion rates of anti-Vi IgG ELISA antibody titers after vaccination of three lots of Vi-DT.
Time frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled)
Seroconversion rate 4
Definded as a Seroconversion rates of anti-Vi IgG ELISA antibody titers at 4 weeks (28 days) after vaccination of three lots of Vi-DT in each age strata
Time frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled)
Seroconversion rate 5
Definded as IgG ELISA antibody titers for Measles (M), and Rubella (R) following single dose of MR a vaccine at baseline D0 and 4 weeks
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Enrollment
1,800
Time frame: 4 weeks (28 days) after vaccination of MR compared to baseline (D0)
Safety endpoints for solicited adverse events (reactogenicity)
Proportion of participants with local and systemic solicited adverse events
Time frame: 7days after vaccination of Vi-DT(pooled)/ Typbar TCV®