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Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks

Primary Purpose

Gastroenteritis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
GSK's liquid oral live attenuated HRV
PCV-free liquid formulation of GSK's oral live attenuated HRV
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroenteritis focused on measuring Rotavirus (RV), Human rotavirus (HRV), Rotarix Porcine circovirus (PCV)-free liquid, Rotarix liquid, Healthy Chinese infants, Immunogenicity, Reactogenicity, Safety

Eligibility Criteria

6 Weeks - 16 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants' parent(s)/legally acceptable representative(s) [LAR(s)], who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. A male or female with Chinese origin, between, and including, 6 and 16 weeks (42-112 days) of age at the time of the first study intervention administration. Healthy participants as established by medical history and clinical examination before entering into the study. Born after a gestation period of 36 to 42 weeks inclusive. Exclusion Criteria: Medical conditions Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). History of severe combined immunodeficiency. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. History of seizures or progressive neurological disease. Family history of congenital or hereditary immunodeficiency. Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS). History of IS. Major congenital defects, or serious chronic illness as assessed by the investigator. Previous confirmed occurrence of rotavirus gastroenteritis (RVGE). Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19). Prior/Concomitant therapy Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the second dose of study intervention administration*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations. *In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization programme, the time period described above can be reduced if, necessary for that mass vaccination vaccine, provided it is licensed and used according to its Product Information. Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period. Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled and topical steroids are allowed. Previous vaccination against RV. Prior/Concurrent clinical study experience - Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product. Other exclusions - Child in care.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational SiteRecruiting
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HRV Group

HRV PCV-free Group

Arm Description

Participants receive 2 doses of GSK's liquid oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.

Participants receive 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.

Outcomes

Primary Outcome Measures

Percentage of seroconverted participants for anti-rotavirus (RV) immunoglobulin A (IgA) antibody (Ab)
A seroconverted participant is a participant who was initially seronegative (i.e., with anti-RV IgA Ab concentration below [<] 20 unit per milliliter [U/mL] prior to the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (>=) 20 U/mL at Month 2 (1 month post Dose 2).
Serum anti-RV IgA Ab concentrations expressed as geometric mean concentrations (GMCs)

Secondary Outcome Measures

Percentage of participants with serum anti-RV IgA Ab concentrations >= 90 U/mL
Percentage of participants reporting solicited systemic events
Solicited systemic events include fever, diarrhea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature >= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla.
Percentage of participants reporting unsolicited adverse events (AEs)
Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Percentage of participants reporting serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious per medical or scientific judgment.

Full Information

First Posted
August 29, 2023
Last Updated
September 7, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT06025695
Brief Title
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
Official Title
A Phase III, Observer-blind, Randomized, Multicenter Study to Evaluate Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid as Compared to GSK's Rotarix Liquid, Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
April 22, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK) oral live attenuated human rotavirus (HRV) study intervention compared to GSK's liquid oral live attenuated HRV study intervention in healthy Chinese infants 6 to 16 weeks of age at the time of the first study intervention administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
Rotavirus (RV), Human rotavirus (HRV), Rotarix Porcine circovirus (PCV)-free liquid, Rotarix liquid, Healthy Chinese infants, Immunogenicity, Reactogenicity, Safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study will be conducted in an observer-blind manner.
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HRV Group
Arm Type
Active Comparator
Arm Description
Participants receive 2 doses of GSK's liquid oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
Arm Title
HRV PCV-free Group
Arm Type
Experimental
Arm Description
Participants receive 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
Intervention Type
Combination Product
Intervention Name(s)
GSK's liquid oral live attenuated HRV
Other Intervention Name(s)
Rotarix
Intervention Description
2 doses of GSK's liquid oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
Intervention Type
Combination Product
Intervention Name(s)
PCV-free liquid formulation of GSK's oral live attenuated HRV
Other Intervention Name(s)
Rotarix PCV-free
Intervention Description
2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
Primary Outcome Measure Information:
Title
Percentage of seroconverted participants for anti-rotavirus (RV) immunoglobulin A (IgA) antibody (Ab)
Description
A seroconverted participant is a participant who was initially seronegative (i.e., with anti-RV IgA Ab concentration below [<] 20 unit per milliliter [U/mL] prior to the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (>=) 20 U/mL at Month 2 (1 month post Dose 2).
Time Frame
At Month 2 (1 month post-Dose 2)
Title
Serum anti-RV IgA Ab concentrations expressed as geometric mean concentrations (GMCs)
Time Frame
At Month 2 (1 month post-Dose 2)
Secondary Outcome Measure Information:
Title
Percentage of participants with serum anti-RV IgA Ab concentrations >= 90 U/mL
Time Frame
At Month 2 (1 month post-Dose 2)
Title
Percentage of participants reporting solicited systemic events
Description
Solicited systemic events include fever, diarrhea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature >= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla.
Time Frame
Within 14 days after each study intervention administration occurring at Day 1 and Month 1
Title
Percentage of participants reporting unsolicited adverse events (AEs)
Description
Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Time Frame
Within 31 days after each study intervention administration occurring at Day 1 and Month 1
Title
Percentage of participants reporting serious adverse events (SAEs)
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious per medical or scientific judgment.
Time Frame
From Dose 1 (Day 1) of the study intervention up to study end (Month 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants' parent(s)/legally acceptable representative(s) [LAR(s)], who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. A male or female with Chinese origin, between, and including, 6 and 16 weeks (42-112 days) of age at the time of the first study intervention administration. Healthy participants as established by medical history and clinical examination before entering into the study. Born after a gestation period of 36 to 42 weeks inclusive. Exclusion Criteria: Medical conditions Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). History of severe combined immunodeficiency. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. History of seizures or progressive neurological disease. Family history of congenital or hereditary immunodeficiency. Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS). History of IS. Major congenital defects, or serious chronic illness as assessed by the investigator. Previous confirmed occurrence of rotavirus gastroenteritis (RVGE). Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19). Prior/Concomitant therapy Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the second dose of study intervention administration*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations. *In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization programme, the time period described above can be reduced if, necessary for that mass vaccination vaccine, provided it is licensed and used according to its Product Information. Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period. Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled and topical steroids are allowed. Previous vaccination against RV. Prior/Concurrent clinical study experience - Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product. Other exclusions - Child in care.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Facility Information:
Facility Name
GSK Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Mianyang
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637300
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Neijiang
State/Province
Sichuan
ZIP/Postal Code
641200
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Miyang Town, Mile City, Honghe Autonomous Prefectu
State/Province
Yunnan
ZIP/Postal Code
652399
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Wenshan
State/Province
Yunnan
ZIP/Postal Code
663300
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Tengchong
ZIP/Postal Code
679100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks

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