Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine
- Conditions
- Typhoid
- Interventions
- Biological: Vi-DTBiological: FluQuadri™Other: 0.9% sodium chloride isotonic solution
- Registration Number
- NCT03527355
- Lead Sponsor
- International Vaccine Institute
- Brief Summary
This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose.
The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age.
The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.
- Detailed Description
This study is carried out in healthy children aged 6 to 23 months at a single site. A total of 285 participants are enrolled, 114, 114 and 57 participants are randomized to either the single dose, two-dose Vi-DT regimens or placebo/comparator group, respectively within age strata. Three age strata is 6 to less than 9 months, 9 to 12 months and 13 to 23 months. The investigators allow the 9-12 months old children to receive Measles-Mumps-Rubella (MMR) vaccine concomitantly with Vi-DT vaccine and descriptive analysis of immune response to MMR only and to MMR and Vi-DT vaccines are performed to assess the possible immunological interference with MMR vaccine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
- Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical judgment of the investigator
- Birth weight ≥ 2500 g
- ≥ 37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant
- Parents aged 18 years and above and legal guardians aged 21 years and above as per the legal authorization in the Philippines, who have voluntarily given informed consent
- Parents/ legal guardians willing to follow the study procedures of the study and available for the entire duration of the study
- Child with a congenital abnormality
- Subject with abnormal routine biological values at screening
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination
- Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
- Child with a previously ascertained or suspected disease caused by S. typhi
- Child who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
- Known history or allergy to vaccines or other medications
- Know history of allergy to eggs, chicken protein, neomycin and formaldehyde
- History of uncontrolled coagulopathy or blood disorders
- Mother has known HIV infection or other immune function disorders
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the study objectives
- Child whose parents or legal guardian planning to move from the study area before the end of study period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A (Single dose) FluQuadri™ One dose of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly at first dost (Day 0). One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Week 24). One booster dose of Vi-DT 0.5 mL is administrated 2 years apart (Week 96). MMR for age group at 9-12 months. A (Single dose) Vi-DT One dose of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly at first dost (Day 0). One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Week 24). One booster dose of Vi-DT 0.5 mL is administrated 2 years apart (Week 96). MMR for age group at 9-12 months. B (Two dose) Vi-DT Two doses of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly 6 months apart (Day 0 and Day 168 (Week 24)). MMR for age group at 9-12 months. C (Placebo/Comparator) FluQuadri™ One dose of Placebo (0.9% sodium chloride isotonic solution) 0.5 mL is administrated intramuscularly at first dost (Day 0). One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Day 168; Week 24). MMR for age group at 9-12 months. C (Placebo/Comparator) 0.9% sodium chloride isotonic solution One dose of Placebo (0.9% sodium chloride isotonic solution) 0.5 mL is administrated intramuscularly at first dost (Day 0). One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Day 168; Week 24). MMR for age group at 9-12 months.
- Primary Outcome Measures
Name Time Method Safety endpoints: solicited and unsolicited adverse events and serious adverse events Solicited AE: during 7 days after each vaccination. Unsolicited AE: after the first vaccination until 4 weeks after the second vaccination. SAE will be captured after the first vaccination up to week 100 for Group A, week 96 for Group B, week 36 Group C * Frequency (percentage) of solicited local reactions at the injection site: Pain, tenderness, erythema/redness, swelling/induration and pruritus local
* Frequency (percentage) of solicited systemic reactions: Fever, lethargy, irritability, vomiting, diarrhea, drowsiness, loss of appetite, persistent crying, rash and nasopharyngitis
* Frequency (percentage) of unsolicited adverse events
* Frequency (percentage) of serious adverse events
- Secondary Outcome Measures
Name Time Method Immunogenicity Endpoints At week 28, 4 weeks after the second vaccination Seroconversion rate of anti-Vi IgG by Geometric Mean Titers (GMT) will be measured 4 weeks after the second vaccination using an in-house ELISA assay using standardized reagents and reference serum. The level of the specific anti-Vi IgG in ELISA units for each serum sample is determined by comparison to a reference serum. The number of anti-Vi IgG positive sera will be used to calculate the seroconversion rates.
Trial Locations
- Locations (1)
Research Institute for Tropical Medicine(RITM)
🇵🇭Alabang, Muntinlupa City, Philippines