NCT06025695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

May 9, 2025

Completed
Last Updated

May 9, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

August 29, 2023

Results QC Date

April 23, 2025

Last Update Submit

April 23, 2025

Conditions

Gastroenteritis

Keywords

Rotavirus (RV)Human rotavirus (HRV)Rotarix Porcine circovirus (PCV)-free liquidRotarix liquidHealthy Chinese infantsImmunogenicityReactogenicitySafety

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate

    Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below \[\<\] 20 unit per milliliter \[U/mL\] prior 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).

    At Month 2 (1-month post-Dose 2)

  • Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)

    At Month 2 (1-month post-Dose 2)

Secondary Outcomes (4)

  • Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL

    At Month 2 (1-month post-Dose 2)

  • Number of Participants Reporting Solicited Systemic Events

    Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1)

  • Number of Participants Reporting Unsolicited Adverse Events (AEs)

    Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1)

  • Number of Participants Reporting Serious Adverse Events (SAEs)

    From Day 1 to Month 7

Study Arms (2)

Human Rotavirus (HRV) Group

ACTIVE COMPARATOR

Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.

Combination Product: GSK's liquid oral live attenuated HRV

HRV Porcine Circovirus (PCV)-free Group

EXPERIMENTAL

Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.

Combination Product: PCV-free liquid formulation of GSK's oral live attenuated HRV

Interventions

GSK's liquid oral live attenuated HRVCOMBINATION_PRODUCT

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.

Also known as: Rotarix
Human Rotavirus (HRV) Group
PCV-free liquid formulation of GSK's oral live attenuated HRVCOMBINATION_PRODUCT

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.

Also known as: Rotarix PCV-free
HRV Porcine Circovirus (PCV)-free Group

Eligibility Criteria

Age6 Weeks - 16 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

GSK Investigational Site

Baoshan, 678099, China

Location

GSK Investigational Site

Baoshan, 678199, China

Location

GSK Investigational Site

Baoshan, 678399, China

Location

GSK Investigational Site

Dali, 672499, China

Location

GSK Investigational Site

Honghe, 652399, China

Location

GSK Investigational Site

Mianyang, 610041, China

Location

GSK Investigational Site

Mianyang, China

Location

GSK Investigational Site

Nanbu-Nanchong, 637300, China

Location

GSK Investigational Site

Neijiang, 641200, China

Location

GSK Investigational Site

Tengchong, 679100, China

Location

GSK Investigational Site

Wenshan, 650034, China

Location

GSK Investigational Site

Wenshan, 663300, China

Location

MeSH Terms

Conditions

Gastroenteritis

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
GSKClinicalSupportHD@gsk.com
866-435-7343

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study will be conducted in an observer-blind manner.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

September 1, 2023

Primary Completion

May 28, 2024

Study Completion

October 23, 2024

Last Updated

May 9, 2025

Results First Posted

May 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

IPD for this study will be made available via the Clinical Study Data Request site.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.
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.

Locations

CN(12)