A Phase 3 interventional study of SII Yellow Fever Vaccine and STAMARIL® in Yellow Fever, sponsored by Serum Institute of India Pvt. Ltd.. Recruiting at 2 sites in 2 countries. Open to participants aged 9 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Serum Institute of India Pvt. Ltd. · Phase 3, Interventional, and Prevention
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.
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.
52 studies on the registry are indexed under Yellow Fever; 10 are open to participants now.
This study's planned enrollment of 2,216 is above the median of 112 across 43 interventional studies indexed under Yellow Fever.
Browse Yellow Fever studies →Serum Institute of India Pvt. Ltd. is the lead sponsor of 26 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: SII Yellow Fever Vaccine
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.
Biological: SII Yellow Fever Vaccine
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.
Biological: SII Yellow Fever Vaccine
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.
Biological: STAMARIL®
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® 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.
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
Time frame: Day 28 post-vaccination
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
Time frame: Day 0 pre-vaccination and Day 28 post-vaccination
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Within 6 months of publication of the study data
Access criteria: Local regulatory authorities, ethics committee
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