Typhoid Clinical Trial
Official title:
A Phase III, Multicenter, Observer Blind, Randomized, Controlled Study to Evaluate Immune Equivalence of Multi-dose Formulation Against Single-dose Formulation of Vi-DT Typhoid Conjugate Vaccine and Safety in Healthy Filipino......
Verified date | August 2021 |
Source | International Vaccine Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population. The study objectives are as follows: - Primary objective. Demonstrate the immune equivalence as measured by anti-Vi IgG Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of Vi-DT (18-45 year age stratum), at 4 weeks after a single dose. - Secondary objective 1. Demonstrate the immune equivalence as measured by seroconversion rates of anti-Vi IgG antibody titres of multi dose formulation against single dose formulation of Vi-DT vaccine (18-45 year age stratum) at 4 weeks after a single dose. - Secondary objective 2. Describe safety profile in all age strata combined (age 6 months - 45 years old) and in each age stratum, at 4 weeks after a single dose of SD/MD formulation/control (Meningococcal Conjugate Vaccine). There are total 5 scheduled visits as follows: - Visit 1(D-7 to 0): Screening - Visit 2(D0): Enrollment, vaccination, safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above) - Visit 3(D7): Safety follow-up - Visit 4(D28): Safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above) - V5(D168): Safety follow-up
Status | Completed |
Enrollment | 1800 |
Est. completion date | January 29, 2021 |
Est. primary completion date | September 11, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 45 Years |
Eligibility | Inclusion Criteria: 1. Healthy participants 6 months to 45 years of age at enrollment 2. Participants/Parent(s)/LAR who have voluntarily given informed consent/assent 3. Participants/Parent(s)/LAR willing to follow the study procedures of the study and available for the entire duration of the study Exclusion Criteria: 1. Child with a congenital abnormality 2. Participant who has already received meningococcal conjugate vaccine 3. Participants concomitantly enrolled or scheduled to be enrolled in another trial 4. Known history of immune function disorders including immunodeficiency diseases (Known HIV infection or other immune function disorders) 5. Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs 6. Receipt of blood or blood-derived products in the past 3 months 7. Participant with a previously ascertained or suspected disease caused by S. Typhi (confirmed either clinically, serologically or microbiologically) 8. Participant who has had household contact with and/or intimate exposure to an individual with laboratory-confirmed S. Typhi 9. Individual who has previously received a typhoid vaccine 10. Participant who has received other vaccines from 1 month prior to test vaccination or planned to receive any vaccine within 1 month (except a measles containing vaccine as per government vaccination campaign) 11. Known history or allergy to vaccines or other medications 12. History of uncontrolled coagulopathy or blood disorders 13. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives 14. Any female participant who is lactating, pregnant* or planning for pregnancy during the course of study period 15. Participants/Parent(s)/LAR planning to move from the study area before the end of study period 16. As per Investigator's medical judgement individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above |
Country | Name | City | State |
---|---|---|---|
Philippines | Lingga Health Research Center | Calamba | Laguna |
Philippines | University of the Philippines Manila-National Institutes of Health | Manila | |
Philippines | Putatan Research Center | Muntinlupa | Metro Manila |
Philippines | Magcase Health Center | San Pablo City | Laguna |
Lead Sponsor | Collaborator |
---|---|
International Vaccine Institute | Bill and Melinda Gates Foundation, SK Bioscience Co., Ltd. |
Philippines,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety endpoints by each formulation and overall and within each age stratum | Frequency of local and systemic solicited adverse events during the 7 days after each dose
Solicited local reactions at the site of injection: pain, tenderness, erythema/redness, swelling/induration and pruritus Solicited systemic reactions (adapted to each age group): fever, lethargy, irritability, nausea/vomiting, arthralgia, diarrhea, drowsiness, loss of appetite, chills, headache, fatigue, myalgia and persistent crying Frequency of unsolicited adverse events during 4 weeks (28 days) after vaccination Frequency of Serious Adverse Events during the entire study period |
Solicited AEs during the 7 days after vaccination/Unsolicited AEs during 4 weeks (28 days) after vaccination/SAEs during the entire study period | |
Primary | Geometric Mean Titers (GMT) of anti-Vi IgG | If the 95% confidence interval of the ratio of GMT estimate of Vi-DT(MD) over GMT of Vi-DT(SD) is located within the bounds of 0.67to 1.5, then Vi-DT (MD) is equivalent to Vi-DT (SD) in terms of GMT of anti-Vi IgG with significance level of 0.05. | At 4 weeks (28 days) post vaccination of Vi-DT (MD/SD) | |
Secondary | Seroconversion rates of anti-Vi IgG ELISA antibody titres | If the 95% confidence interval of the estimate of difference of seroconversion rate between Vi-DT (MD) and Vi-DT (SD) at 4 weeks (Day 28) is located within the bounds -10% to 10%, then Vi-DT (MD) is equivalent to Vi-DT (SD) in terms of sero-conversion rate, which is defined as 4 fold increase of anti Vi IgG from baseline with significance level of 0.05. | At 4 weeks (28 days) from baseline (Day 0; before vaccination of Vi-DT (MD/SD) |
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