A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants

November 22, 2023 updated by: Serum Institute of India Pvt. Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

2216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Gambia
      • Banjul, Gambia, 273
        • Recruiting
        • MRC Unit The Gambia at LSHTM
        • Contact:
  • Mali
      • Bamako, Mali, 251
        • Recruiting
        • Center for Vaccine Development
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy infants as established by medical history and clinical examination
  2. 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)
  3. Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements.
  4. Intend to remain residing in the study area throughout study participation
  5. Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants for the duration of the study

Exclusion Criteria:

  1. 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].
  2. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SII Yellow Fever Vaccine Lot A

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 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.
Experimental: SII Yellow Fever Vaccine Lot B

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 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.
Experimental: SII Yellow Fever Vaccine Lot C

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

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.
Active Comparator: 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.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yellow Fever Vaccine GMTs
Time Frame: Day 0 pre-vaccination and Day 28 post-vaccination

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
Day 0 pre-vaccination and Day 28 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serum Institute of India Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YWF:02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Within 6 months of publication of the study data

IPD Sharing Access Criteria

Local regulatory authorities, ethics committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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