A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Typhoid
- Sponsor
- International Vaccine Institute
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- Safety endpoints: solicited and unsolicited adverse events and serious adverse events
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Safety endpoints: solicited and unsolicited adverse events and serious adverse events
Time Frame: 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 Outcomes
- Immunogenicity Endpoints(At week 28, 4 weeks after the second vaccination)