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

Primary Purpose

Yellow Fever

Status

Not yet recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

SII Yellow Fever Vaccine

STAMARIL®

About this trial

This is an interventional prevention trial for Yellow Fever

Eligibility Criteria

9 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

MRC Unit The Gambia at LSHTM
Center for Vaccine Development

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

SII Yellow Fever Vaccine Lot A

SII Yellow Fever Vaccine Lot B

SII Yellow Fever Vaccine Lot C

STAMARIL®

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05447377

First Posted

June 21, 2022

Last Updated

July 1, 2022

Sponsor

Serum Institute of India Pvt. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05447377

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 30, 2022 (Anticipated)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Serum Institute of India Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Yellow Fever

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SII Yellow Fever Vaccine Lot A

Arm Type

Experimental

Arm Description

Arm Title

SII Yellow Fever Vaccine Lot B

Arm Type

Experimental

Arm Description

Arm Title

SII Yellow Fever Vaccine Lot C

Arm Type

Experimental

Arm Description

Arm Title

STAMARIL®

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

SII Yellow Fever Vaccine

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

STAMARIL®

Intervention Description

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.

Primary Outcome Measure Information:

Title

YF neutralizing antibody (NAb) seroconversion

Description

Time Frame

Day 28 post-vaccination

Secondary Outcome Measure Information:

Title

Yellow Fever Vaccine GMTs

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Months

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dr Prasad Kulkarni, MD

Phone

00912071946820

drpsk@seruminstitute.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dr Sajjad Desai, MD

Phone

00912071946821

sajjad.desai@seruminstitute.com

Facility Information:

Facility Name

MRC Unit The Gambia at LSHTM

City

Banjul

ZIP/Postal Code

273

Country

Gambia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ed Clarke

Phone

+2207039732

Ed.Clarke@lshtm.ac.uk

Facility Name

Center for Vaccine Development

City

Bamako

ZIP/Postal Code

251

Country

Mali

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samba Sow

Phone

0022376348947

ssow@cvd-mali.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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