Yellow FeverPhase 3NCT05447377
A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants
A Phase 3 study testing SII Yellow Fever Vaccine and STAMARIL® in people with Yellow Fever, run by Serum Institute of India Pvt. Ltd. at 2 sites in 2 countries.
Trial summary
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV. Read more about this study
- Who is it for?
- Ages 9 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever
- What is being tested?
- SII Yellow Fever Vaccine and STAMARIL®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,216 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Sep 2022to 30 Jan 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 9 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants as established by medical history and clinical examination
- Male or female infants aged 9 to < 12 months (from the day they reach 9 months-of-age until the day before they reach 12-months/1-year-of-age)
- Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements.
- Intend to remain residing in the study area throughout study participation
- Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants 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 rescreened at least 48 hours after the last recorded fever].
- Previous history of laboratory confirmed infection with yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
- 5. Previous vaccination against yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, TBE, JE, or dengue fever.
- 6. Receipt of any vaccine within past 28 days or planned vaccination until completion of day 28 study visit 7. 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 8. Receipt of immunoglobulin therapy and/or blood products since birth or planned administration until completion of Day 28 visit 9. Current or planned participation in another interventional study at any point throughout the entire study period 10. Receipt of any other investigational product or unlicensed medication in the preceding 28 days, or planned use until completion of Day 28 visit 7. Presence of significant malnutrition (weight-for-height z-score < -3SD)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Mali1 site, 1 recruiting
- Recruiting
Center for Vaccine Development
Bamako, 251
Samba Sow, 0022376348947, ssow@cvd-mali.org
The Gambia1 site, 1 recruiting
- Recruiting
MRC Unit The Gambia at LSHTM
Banjul, 273
Ed Clarke, +2207039732, Ed.Clarke@lshtm.ac.uk
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® In Healthy Infants
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
Read the detailed description
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
A single dose of either SII-YFV or STAMARIL® will be administered concomitantly with an MMR and a Men A vaccine. The study will start only after the approval from the applicable ethics committees and national regulatory agencies. Following parental / guardian consent, participants will be screened for eligibility based on the defined inclusion and exclusion criteria for the trial. 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.
- Conditions
- Yellow Fever
- Being tested
- SII Yellow Fever Vaccine, STAMARIL®
- Medical subject headings
- Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SII Yellow Fever VaccineBiological
SII YF vaccine:
Live attenuated Yellow Fever Virus (17D-213 Strain) not less than 1000 IU/dose propagated in specific pathogen-free chick embryos.
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.
After reconstitution, 1 dose (0.5 mL) contains:
- Yellow fever virus 17D-213 strain (live, attenuated) not less than 1000 IU propagated in specific pathogen-free chick embryos
- Excipients with known effects:
- This product contains approximately 5 mg of sorbitol per dose.
STAMARIL®Biological
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.
After reconstitution, 1 dose (0.5 mL) contains:
- Yellow fever virus 17D-204 strain (live, attenuated) not less than 1000 IU propagated in specific pathogen-free chick embryos
- Excipients with known effects:
- This product contains approximately 8 mg of sorbitol (E420) per dose.
| Study group | Role | What they receive |
|---|---|---|
| SII Yellow Fever Vaccine Lot A | Experimental | SII-YFV Lot A:
SII Yellow Fever vaccine is 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
In this arm a total of 554 participants will be enrolled. All participants will receive a single dose of SII-YFV Lot A will be administered concomitantly with an MMR and a Men A vaccine. Receives: Biological: SII Yellow Fever Vaccine |
| SII Yellow Fever Vaccine Lot B | Experimental | SII-YFV Lot B:
SII Yellow Fever vaccine is 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
In this arm a total of 554 participants will be enrolled. All participants will receive a single dose of SII-YFV Lot B will be administered concomitantly with an MMR and a Men A vaccine. Receives: Biological: SII Yellow Fever Vaccine |
| SII Yellow Fever Vaccine Lot C | Experimental | SII-YFV Lot C:
SII Yellow Fever vaccine is 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
In this arm a total of 554 participants will be enrolled. All participants will receive a single dose of SII-YFV Lot C will be administered concomitantly with an MMR and a Men A vaccine. Receives: Biological: SII Yellow Fever Vaccine |
| STAMARIL® | Active comparator | STAMARIL is a 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.
In this arm a total of 554 participants will be enrolled. All participants will receive a single dose of STAMARIL will be administered concomitantly with an MMR and a Men A vaccine. 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
Non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT50).
Percentage seroconversion* on Day 28 post-vaccination
- Seroconversion is defined as a four-fold rise in YF NAb (PRNT50) titres from baseline
Measured: Day 28 post-vaccination
Secondary outcomes (1)
Yellow Fever Vaccine GMTs
GMTs on Day 0 pre-vaccination and Day 28 post-vaccination
Equivalence of the immune responses generated by three different manufacturing lots of SII-YFV
Measured: Day 0 pre-vaccination and Day 28 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start16 Sep 2022
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
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
- 2,216 participants (estimated)
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
- NCT05447377
- Sponsor's protocol ID
- YWF:02
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2022
- Last updated
- 28 Nov 2023
- 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 28 Nov 2023. 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® In Healthy Infants
- ClinicalTrials.gov ID
- NCT05447377
- Acronym / sponsor ID
- YWF:02
- Conditions
- Yellow Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,216 participants (estimated)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 7 Jul 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, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
Detailed description
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
A single dose of either SII-YFV or STAMARIL® will be administered concomitantly with an MMR and a Men A vaccine. The study will start only after the approval from the applicable ethics committees and national regulatory agencies. Following parental / guardian consent, participants will be screened for eligibility based on the defined inclusion and exclusion criteria for the trial. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SII Yellow Fever Vaccine Lot A | Experimental | Biological: SII Yellow Fever VaccineSII-YFV Lot A: SII Yellow Fever vaccine is 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 In this arm a total of 554 participants will be enrolled. All participants will receive a single dose of SII-YFV Lot A will be administered concomitantly with an MMR and a Men A vaccine. |
| SII Yellow Fever Vaccine Lot B | Experimental | Biological: SII Yellow Fever VaccineSII-YFV Lot B: SII Yellow Fever vaccine is 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 In this arm a total of 554 participants will be enrolled. All participants will receive a single dose of SII-YFV Lot B will be administered concomitantly with an MMR and a Men A vaccine. |
| SII Yellow Fever Vaccine Lot C | Experimental | Biological: SII Yellow Fever VaccineSII-YFV Lot C: SII Yellow Fever vaccine is 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 In this arm a total of 554 participants will be enrolled. All participants will receive a single dose of SII-YFV Lot C will be administered concomitantly with an MMR and a Men A vaccine. |
| STAMARIL® | Active comparator | Biological: STAMARIL®STAMARIL is a 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. In this arm a total of 554 participants will be enrolled. All participants will receive a single dose of STAMARIL will be administered concomitantly with an MMR and a Men A vaccine. |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infants as established by medical history and clinical examination
- Male or female infants aged 9 to < 12 months (from the day they reach 9 months-of-age until the day before they reach 12-months/1-year-of-age)
- Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements.
- Intend to remain residing in the study area throughout study participation
- Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants for the duration of the study
Key exclusion criteria (4 listed)
- Fever (> 37.5°C) or any clinically significant acute infection at time of vaccination [Temporary exclusion criteria - participants may be rescreened at least 48 hours after the last recorded fever].
- Previous history of laboratory confirmed infection with yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
- 5. Previous vaccination against yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, TBE, JE, or dengue fever.
- 6. Receipt of any vaccine within past 28 days or planned vaccination until completion of day 28 study visit 7. 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 8. Receipt of immunoglobulin therapy and/or blood products since birth or planned administration until completion of Day 28 visit 9. Current or planned participation in another interventional study at any point throughout the entire study period 10. Receipt of any other investigational product or unlicensed medication in the preceding 28 days, or planned use until completion of Day 28 visit 7. Presence of significant malnutrition (weight-for-height z-score < -3SD)
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 |
|---|---|---|
| SII Yellow Fever VaccineSII YF vaccine: Live attenuated Yellow Fever Virus (17D-213 Strain) not less than 1000 IU/dose propagated in specific pathogen-free chick embryos. 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. After reconstitution, 1 dose (0.5 mL) contains: * Yellow fever virus 17D-213 strain (live, attenuated) not less than 1000 IU propagated in specific pathogen-free chick embryos * Excipients with known effects: * This product contains approximately 5 mg of sorbitol per dose. | Biological | SII Yellow Fever Vaccine Lot A, SII Yellow Fever Vaccine Lot B, SII Yellow Fever Vaccine Lot C |
| STAMARIL®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. After reconstitution, 1 dose (0.5 mL) contains: * Yellow fever virus 17D-204 strain (live, attenuated) not less than 1000 IU propagated in specific pathogen-free chick embryos * Excipients with known effects: * This product contains approximately 8 mg of sorbitol (E420) per dose. | Biological | STAMARIL® |
Primary outcome
YF neutralizing antibody (NAb) seroconversion
Time frame: Day 28 post-vaccination
Non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT50). Percentage seroconversion* on Day 28 post-vaccination * Seroconversion is defined as a four-fold rise in YF NAb (PRNT50) titres from baseline
1 secondary outcome
Yellow Fever Vaccine GMTs
Time frame: Day 0 pre-vaccination and Day 28 post-vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SII Yellow Fever Vaccine and STAMARIL® in people with Yellow Fever, run by Serum Institute of India Pvt. Ltd. at 2 sites in 2 countries.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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 Mali, The Gambia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Prasad Kulkarni, MD (00912071946820, drpsk@seruminstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YF neutralizing antibody (NAb) seroconversion (time frame: Day 28 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 28 Nov 2023.