> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/immunogenicity-reactogenicity-and-safety-of-glaxosmithkline-8ece3e7c-9201-4e1d-81e2-df8525658cd8 > Record changed: 2026-10-13 # 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 NCT06025695 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) Participants 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) Start date 2023-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Short 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Dates **Completion date** 2024-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **First posted** 2023-09-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Registry last updated** 2025-05-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Primary completion date** 2024-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Start date** 2023-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Size and sites **Actual participants** 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Participants** 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Identifiers **Registry ID** NCT06025695 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **ClinicalTrials.gov ID** NCT06025695 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** This study will be conducted in an observer-blind manner. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Outcomes ### Primary outcomes 1. Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate Timeframe: At Month 2 (1-month post-Dose 2) 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). 2. Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs) Timeframe: At Month 2 (1-month post-Dose 2) ### Secondary outcomes 1. Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL Timeframe: At Month 2 (1-month post-Dose 2) 2. Number of Participants Reporting Solicited Systemic Events Timeframe: Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1) Solicited systemic events include fever/pyrexia, diarrhoea, 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. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. 3. Number of Participants Reporting Unsolicited Adverse Events (AEs) Timeframe: Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1) 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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination 4. Number of Participants Reporting Serious Adverse Events (SAEs) Timeframe: From Day 1 to Month 7 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 as per medical or scientific judgment. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Weeks **Maximum age** 16 Weeks **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Sites - GSK Investigational SiteBaoshan, China - GSK Investigational SiteBaoshan, China - GSK Investigational SiteBaoshan, China - GSK Investigational SiteDali, China - GSK Investigational SiteHonghe, China - GSK Investigational SiteMianyang, China - GSK Investigational SiteMianyang, China - GSK Investigational SiteNanbu-Nanchong, China - GSK Investigational SiteNeijiang, China - GSK Investigational SiteTengchong, China - GSK Investigational SiteWenshan, China - GSK Investigational SiteWenshan, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## References ### Other registry identifiers - 2020-000972-38 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06025695) ## Related records ### Drugs (2) - [Guselkumab](https://trialight.com/data/asset/guselkumab-90846a1b-25ed-4e53-ae9c-4730391bc3c9.md) - [Polatuzumab vedotin](https://trialight.com/data/asset/polatuzumab-vedotin-0d7ba42f-27fc-4954-85ff-18eee7fdddc9.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Gastroenteritis](https://trialight.com/data/condition/gastroenteritis-6f158f22-dfd3-577b-847d-64d9cf80af87.md) Primary condition ### Targets (18) - [CD79B](https://trialight.com/data/target/cd79b-f3f16d0c-0c02-5861-9791-1481475ed6ee.md) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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