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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000972-38 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK's liquid oral live attenuated HRV | Combination 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Medical conditions
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Baoshan | 678099 | China | |||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
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 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.
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One participant was randomized to the HRV group but was vaccinated in the HRV PCV-free group. Data for this participant was analyzed in the HRV PCV-free group for all analyses.
This study was conducted in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Human Rotavirus (HRV) Group | Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1. |
| FG001 | HRV Porcine Circovirus (PCV)-Free Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2023 | Apr 23, 2025 |
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This study will be conducted in an observer-blind manner.
|
| PCV-free liquid formulation of GSK's oral live attenuated HRV | Combination 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. |
|
|
| 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) | 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 | 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) | 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. | From Day 1 to Month 7 |
| Baoshan |
| 678199 |
| China |
| GSK Investigational Site | Baoshan | 678399 | China |
| GSK Investigational Site | Dali | 672499 | China |
| GSK Investigational Site | Honghe | 652399 | China |
| GSK Investigational Site | Mianyang | 610041 | China |
| GSK Investigational Site | Mianyang | China |
| GSK Investigational Site | Nanbu-Nanchong | 637300 | China |
| GSK Investigational Site | Neijiang | 641200 | China |
| GSK Investigational Site | Tengchong | 679100 | China |
| GSK Investigational Site | Wenshan | 650034 | China |
| GSK Investigational Site | Wenshan | 663300 | China |
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.
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Human Rotavirus (HRV) Group | Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1. |
| BG001 | HRV Porcine Circovirus (PCV)-Free Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | WEEKS |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Analysis was performed on Per Protocol Set (PPS), which includes all participants who adhered to the study protocol, ensuring they received no unapproved treatments, remained blinded, had anti-RV concentration <20 U/mL before intervention, had available anti-RV results at Month 2, complied with blood sampling schedules, and had no concurrent infections. Only participants with data available at specified timepoints were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 2 (1-month post-Dose 2) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs) | Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | U/mL | At Month 2 (1-month post-Dose 2) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL | Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 2 (1-month post-Dose 2) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Solicited Systemic Events | 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. | Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and with the solicited systemic events diary card data available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis. | Posted | Count of Participants | Participants | Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number 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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination | Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom unsolicited AEs data were available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis. | Posted | Count of Participants | Participants | Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number 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 as per medical or scientific judgment. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. | Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom SAE data were available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis. | Posted | Count of Participants | Participants | From Day 1 to Month 7 |
|
Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7.
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Human Rotavirus (HRV) Group | Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1. | 1 | 998 | 251 | 998 | 596 | 998 |
| EG001 | HRV Porcine Circovirus (PCV)-Free Group | 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. | 0 | 1,002 | 262 | 1,002 | 617 | 1,002 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Laryngopharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Enterobacter pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia escherichia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Tracheobronchitis mycoplasmal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastroenteritis adenovirus | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pharyngitis bacterial | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Coxsackie viral infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pharyngitis mycoplasmal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bronchitis mycoplasmal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia moraxella | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Infantile diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Congenital megacolon | Congenital, familial and genetic disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Craniosynostosis | Congenital, familial and genetic disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vascular malformation | Congenital, familial and genetic disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Lymphangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Eczema infected | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Infantile diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gingival cyst | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Infantile colic | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyschezia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Mucous stools | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypoventilation neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sleep terror | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperlactacidaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acid-base balance disorder mixed | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vitamin K deficiency | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pityriasis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myocardial necrosis marker increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Immunoglobulins decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Bile acids increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypofibrinogenaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Secondary thrombocytosis | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypercholia | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Congenital laryngeal stridor | Congenital, familial and genetic disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Congenital laryngeal malformation | Congenital, familial and genetic disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Transient hypogammaglobulinaemia of infancy | Immune system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Transient neonatal hyperthyrotropinaemia | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2023 | Apr 23, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
Not provided
Not provided
Not provided
| Male |
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