Yellow Fever
Conditions
Brief summary
The study is designed as a Phase III, double-blind, multicenter, randomized, active-controlled, parallel-group design in which two groups of participants will receive either SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV. The study will start only after the approval from the applicable ethics committees and national regulatory agencies.
Detailed description
There will be three scheduled visits during the study. A screening and vaccination visit (Day 0) followed by additional study visits on Day 28 and on Day 180 post-vaccination. Throughout the study, participants/parent/guardian will be encouraged to contact the study team if the participant is unwell and the study team will additionally maintain contact with study participants. The participant or parent/guardian will be contacted telephonically on Day 90 to enquire about participant's health and occurrence of any serious adverse events (SAEs). Active surveillance for vaccine reactogenicity will be conducted in reactogenicity cohort from the time of vaccination (Day 0) until Day 10 following vaccination. Unsolicited AE will be collected from all study participants until Day 28 post vaccination. SAEs will be collected from all participants throughout the study (to Day 180).
Interventions
BIOLOGICALSTAMARIL
STAMARIL® contains the 17D-204 vaccine strain, which is used in many currently produced yellow fever vaccines. STAMARIL is specific pathogen free embryonated hen's egg based and is prepared by harvesting and stabilizing the virus collected from the homogenized chicken embryos infected with YF vaccine virus. STAMARIL® will be used as a comparator in the study. It is a live, attenuated, freeze-dried (lyophilized) vaccine and is to be reconstituted with solvent.
BIOLOGICALSII-YFV
SII-YFV contains the 17D-213 vaccine strain, a derivative of 17D-204 strain which is used in many currently produced yellow fever vaccines. SIIPL imported the YF WHO Primary Seed Virus lot 213-77 from National Institute for Biological Standards and Control (NIBSC) for preparation of the master seed virus, working seed virus and the vaccine. The SII-YFV is specific pathogen free embryonated hen's egg based and is prepared by harvesting and stabilizing the virus collected from the homogenized chicken embryos infected with YF working seed virus. SII-YFV will be provided in vial presentation for the study. It is a live, attenuated, freeze-dried (lyophilized) vaccine and is to be reconstituted with sterile water for injection.
Sponsors
Serum Institute of India Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female volunteers aged ≥ 1 year 2. Healthy volunteers as determined by medical history and clinical examination 3. Participants willing to adhere to the protocol requirements and to provide informed consent for participants ≥ 18 years of age. For participants \< 18 years of age, parental/guardian ability and willingness to provide informed consent (as per local requirements/procedures) and additional informed assent from participants, as appropriate for participating community (i.e. participants at least 7 years of age in Kenya) 4. Intend to remain residing in study area throughout the study participation 5. Female participants of childbearing potential\* must have practiced adequate contraception\*\* and agree to continue adequate contraception till Day 28 post-vaccination. 6. Female participants of childbearing potential must have a negative pregnancy test within 24 hours prior to IP administration. 7. Be willing to avoid the use of traditional/herbal local medications and treatments for the duration of the study
Exclusion criteria
1. Fever (\> 37.5°C) or any clinically significant acute infection at time of vaccination \[Temporary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| YF neutralizing antibody (NAb) seroconversion rates | 28 days post vaccination | NI comparison for primary objective of the study will be based on seroconversion rate at 28 days post vaccination i.e. percentage of participants achieving seroconversion. Seroconversion is defined as a fourfold increase in neutralizing antibody from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs achieved with SII-YFV versus STAMARIL | 28 days post vaccination | To compare the YF NAb geometric mean titres (GMTs) generated following SII-YFV to those generated following STAMARIL®. |
Countries
Kenya
Outcome results
None listed