Yellow FeverPhase 3NCT05421611
A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL
A Phase 3 study testing STAMARIL and SII-YFV in people with Yellow Fever, run by Serum Institute of India Pvt. Ltd. at 2 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever
- What is being tested?
- STAMARIL and SII-YFV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,824 participants
- Where
- 2 sitesKenya
- Study dates
- 11 May 2023to 10 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female volunteers aged ≥ 1 year
- Healthy volunteers as determined by medical history and clinical examination
- 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)
- Intend to remain residing in study area throughout the study participation
- Female participants of childbearing potential* must have practiced adequate contraception** and agree to continue adequate contraception till Day 28 post-vaccination.
- Female participants of childbearing potential must have a negative pregnancy test within 24 hours prior to IP administration.
- Be willing to avoid the use of traditional/herbal local medications and treatments for the duration of the study
Who cannot join
- Fever (> 37.5°C) or any clinically significant acute infection at time of vaccination [Temporary exclusion criteria - participants may be re-screened at least 48 hours after the last recorded fever]
- Use of systemic (oral or parenteral) antibiotics or antiviral agents within the past 7 days. [Temporary exclusion criteria - participants may be re-screened at least 7 days after last dose of antibiotics or antiviral agents]
- Use of traditional/herbal local medications and treatments in the past 7 days [Temporary exclusion criteria - participants may be re-screened at least 7 days after last consumption of traditional/herbal local medications and treatment]
- Previous history of laboratory confirmed infection with yellow fever and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
- Previous vaccination against yellow fever, TBE, JE, or dengue fever.
- Receipt of any vaccine within past 28 days or planned vaccination until completion of Day 28 visit
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- Known or suspected impairment of immunological function based on medical history and physical examination.
- Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol
- History of chronic administration (defined as more than 14 consecutive days) of immunosuppressant (> 0.5 mg/kg/day of prednisolone or equivalent) or other immune modifying drugs including the use of glucocorticoids. The use of topical/inhaled/per nasal glucocorticoids will be permitted.
- A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life-threatening reaction to any past vaccine.
- Receipt of any immunoglobulin therapy and / or blood products in the past 60 days or planned administration until completion of Day 28 visit.
- Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period
- Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit
- Uncontrolled coagulopathy or blood disorder contraindicating subcutaneous injections or blood sampling
- Be an employee of, or direct descendant (child or grandchild) of any person employed by the investigator or sponsor.
- Pregnant or lactating women
- Requirement of Yellow Fever vaccination certificate for travelling purpose
- History of thymus dysfunction including myasthenia gravis, thymoma, thymectomy
- History or presence of significant alcoholism or drug abuse in the past one year
- Major congenital or genetic defect
- Any other condition which in the opinion of the investigator will jeopardize the safety of the participant or compromise the assessment of the study objectives
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Victoria Biomedical Research Institute (VIBRI) - Kisumu County Referral Hospital
Kisumu, 7180-40100
Kenya Medical Research Institute/ Centre for Research Disease Research (CRDR)
Nairobi, 47855-00100
About this study
Official title: A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL
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.
Read the 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).
- Conditions
- Yellow Fever
- Being tested
- STAMARIL, SII-YFV
- Medical subject headings
- Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAMARILBiological
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.
SII-YFVBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| SII-YFV | Experimental | Live attenuated Yellow Fever Virus (17D-213 Strain) not less than 1000 IU/dose propagated in specific pathogen-free chick embryos
Diluent: 0.5 mL of sterile water for injection Receives: Biological: SII-YFV |
| STAMARIL | Active comparator | Live attenuated Yellow Fever Virus (17D-204 Strain) not less than 1000 IU/dose produced in specified pathogen-free chick embryos
Solvent: Sodium Chloride 2.0 mg; Water for injections up to 0.5 mL Receives: Biological: STAMARIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
YF neutralizing antibody (NAb) seroconversion rates
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.
Measured: 28 days post vaccination
Secondary outcomes (1)
GMTs achieved with SII-YFV versus STAMARIL
To compare the YF NAb geometric mean titres (GMTs) generated following SII-YFV to those generated following STAMARIL®.
Measured: 28 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start11 May 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yellow FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421611
- Sponsor's protocol ID
- YWF:03
- Status last verified
- May 2025
- First submitted
- 13 Jun 2022
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected from this study will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. other study details are available on clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL
- ClinicalTrials.gov ID
- NCT05421611
- Acronym / sponsor ID
- YWF:03
- Conditions
- Yellow Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,824 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SII-YFV | Experimental | Biological: SII-YFVLive attenuated Yellow Fever Virus (17D-213 Strain) not less than 1000 IU/dose propagated in specific pathogen-free chick embryos Diluent: 0.5 mL of sterile water for injection |
| STAMARIL | Active comparator | Biological: STAMARILLive attenuated Yellow Fever Virus (17D-204 Strain) not less than 1000 IU/dose produced in specified pathogen-free chick embryos Solvent: Sodium Chloride 2.0 mg; Water for injections up to 0.5 mL |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female volunteers aged ≥ 1 year
- Healthy volunteers as determined by medical history and clinical examination
- 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)
- Intend to remain residing in study area throughout the study participation
- Female participants of childbearing potential* must have practiced adequate contraception** and agree to continue adequate contraception till Day 28 post-vaccination.
Key exclusion criteria (21 listed)
- Fever (> 37.5°C) or any clinically significant acute infection at time of vaccination [Temporary exclusion criteria - participants may be re-screened at least 48 hours after the last recorded fever]
- Use of systemic (oral or parenteral) antibiotics or antiviral agents within the past 7 days. [Temporary exclusion criteria - participants may be re-screened at least 7 days after last dose of antibiotics or antiviral agents]
- Use of traditional/herbal local medications and treatments in the past 7 days [Temporary exclusion criteria - participants may be re-screened at least 7 days after last consumption of traditional/herbal local medications and treatment]
- Previous history of laboratory confirmed infection with yellow fever and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
- Previous vaccination against yellow fever, TBE, JE, or dengue fever.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAMARILSTAMARIL® 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. | Biological | STAMARIL |
| SII-YFVSII-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. | Biological | SII-YFV |
Primary outcome
YF neutralizing antibody (NAb) seroconversion rates
Time frame: 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.
1 secondary outcome
GMTs achieved with SII-YFV versus STAMARIL
Time frame: 28 days post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Yes. Data collected from this study will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. other study details are available on clinicaltrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STAMARIL and SII-YFV in people with Yellow Fever, run by Serum Institute of India Pvt. Ltd. at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YF neutralizing antibody (NAb) seroconversion rates (time frame: 28 days post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.