A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants

A Phase III, Open-label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Porcine Circovirus (PCV)-Free Liquid Formulation of an Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Chinese Infants

The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment.

Study Overview

• Status: Recruiting
• Conditions: Gastroenteritis
• Intervention / Treatment: Combination product: HRV PCV-free; Combination product: IPV

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Study Locations

• China
  • Wenshan, China, 663100
    • Recruiting
    • GSK Investigational Site
    • Principal Investigator: Xiaoqing Liu
    • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
    • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • GSK Investigational Site
      • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
      • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com
      • Principal Investigator: Xuecheng Liu
    • Guang'an, Sichuan, China, 638300
      • Recruiting
      • GSK Investigational Site
      • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
      • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com
      • Principal Investigator: Xuecheng Liu
    • Neijiang, Sichuan, China, 641200
      • Recruiting
      • GSK Investigational Site
      • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
      • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com
      • Principal Investigator: Yulin Jing
  • Yunnan
    • Wenshan, Yunnan, China, 663300
      • Recruiting
      • GSK Investigational Site
      • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
      • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com
      • Principal Investigator: Xiaoqiang Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.
• Healthy participants as established by medical history and clinical examination before entering into the study.
• A male or female of Chinese origin, between and including, 6 and 10 weeks (42-76 days) of age at the time of study enrolment.
• Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

Medical conditions

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Hypersensitivity to latex.
• History of severe combined immunodeficiency.
• 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.
• Any contraindications to IPV.
• Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).
• History of poliomyelitis.
• 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 last dose of study interventions 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 recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

• Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period.
• Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration 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, intra-articular and topical steroids are allowed.
• Previous vaccination against RV.
• Previous vaccination against poliomyelitis.

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 intervention.

Other exclusions

- Child in care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Co-administration Group; Participants receive 2 doses of HRV PCV-free vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.	Combination product: HRV PCV-free; 2 doses of HRV PCV-free vaccine are administered orally at Month 0.5 and Month 1.5 (Co-administration Group) and at Day 1 and Month 1 (Staggered Group), according to the immunization schedule for HRV vaccine 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.; Other Names: Rotarix PCV-free; Combination product: IPV; 3 doses of IPV vaccine are administered intramuscularly at Month 0.5, Month 1.5 and Month 2.5 (Co-administration Group and Staggered Group), according to the recommended schedule for vaccination against poliovirus in China.; Other Names: Beijing Biological Products Institute Co.,Ltd.'s Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero Cells)
Active Comparator: Staggered Group; Participants receive 2 doses of HRV PCV-free vaccine administered at Day 1 and Month 1, and 3 doses of IPV vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Combination product: HRV PCV-free; 2 doses of HRV PCV-free vaccine are administered orally at Month 0.5 and Month 1.5 (Co-administration Group) and at Day 1 and Month 1 (Staggered Group), according to the immunization schedule for HRV vaccine 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.; Other Names: Rotarix PCV-free; Combination product: IPV; 3 doses of IPV vaccine are administered intramuscularly at Month 0.5, Month 1.5 and Month 2.5 (Co-administration Group and Staggered Group), according to the recommended schedule for vaccination against poliovirus in China.; Other Names: Beijing Biological Products Institute Co.,Ltd.'s Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero Cells)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab)	Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (<) 1:8 at pre-vaccination, - >= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer >= 1:8 at pre-vaccination.	At 1 month post-Dose 3 of IPV (Month 3.5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-poliovirus types 1, 2 and 3 neutralizing Ab geometric mean titers (GMTs)		At 1 month post-Dose 3 of IPV (Month 3.5)
Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64		At 1 month post-Dose 3 of IPV (Month 3.5)
Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab	Seroconversion for anti-RV IgA Ab is defined as: anti-RV IgA Ab concentration >= 20 unit per milliliter (U/mL) at 1 month post-Dose 2 of HRV PCV-free vaccine, in participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration < 20 U/mL prior to the first dose of HRV PCV-free vaccine).	At 1 month post-Dose 2 of HRV PCV-free (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Anti-RV IgA Ab geometric mean concentrations (GMCs)		At 1 month post-Dose 2 of HRV PCV-free (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL		At 1 month post-Dose 2 of HRV PCV-free (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
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.	Within 14 days after Dose 1 and Dose 2 of HRV PCV-free and IPV (Dose 1&2 administered at Day 1 & Month 1 (HRV PCV-free) and at Month 0.5 & Month 1.5 (IPV) for Staggered Group and at Month 0.5 & Month 1.5 (HRV PCV-free & IPV) for Co-administration Group)
Percentage of participants reporting unsolicited adverse events (AEs)	Unsolicited AEs include any AE reported in addition to those solicited during the clinical study.	Within 31 days after each dose of HRV PCV-free (HRV PCV-free administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group)
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.	From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): November 19, 2024
• Study Completion (Estimated): November 19, 2024

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Inactivated poliovirus vaccine (IPV); Human rotavirus (HRV); Rotarix Porcine circovirus (PCV)-free liquid; Healthy Chinese infants
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 218485; 2022-000708-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
• 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
• product manufactured in and exported from the U.S.: No