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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000708-36 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-administration Group | Experimental | Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV 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. |
|
| Staggered Group | Active Comparator | Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRV PCV-free | Combination Product | 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. |
| 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 Month 3.5 (1 month post-Dose 3 of IPV) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | At Month 3.5 (1 month post-Dose 3 of IPV) | |
| Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | At Month 3.5 (1 month post-Dose 3 of IPV) |
Not provided
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 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mianyang | 610041 | China | |||
| GSK Investigational Site |
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/
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.
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.
A total of 400 participants were included in Enrolled set, out of which only 392 were included in Exposed set and started the study.
This study was conducted in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Staggered Group | Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5. |
| FG001 |
| 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 | Oct 25, 2023 | Oct 1, 2025 |
Not provided
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Not provided
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|
|
| IPV | Combination Product | 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. |
|
|
| 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 vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group) |
| Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab | At 1 month post-Dose 2 of HRV PCV-free vaccine (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 vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group) |
| Number of Participants Reporting Any Solicited Systemic Events | Solicited systemic events include cough/runny nose, diarrhoea, fever (pyrexia), irritability/fussiness, loss of appetite and vomiting. 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. | Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group) |
| Number of Participants Reporting Any 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 after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group) |
| Number of Participants Reporting Any 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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. | 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) |
| Neijiang |
| 641200 |
| China |
| GSK Investigational Site | Wenshan | 663100 | China |
| GSK Investigational Site | Wenshan | 663300 | China |
| GSK Investigational Site | Yuechi-Guang'an | 638300 | China |
| Co-administration Group |
Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Staggered Group | Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5. |
| BG001 | Co-administration Group | Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV 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. |
| 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 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. | Analysis was performed on the per protocol set (PPS) for IPV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-poliovirus types 1, 2, and 3 at 1 month post-Dose 3, participants must have pre- and post-vaccination immunogenicity data for at least one antigen and adhered to the interval between Dose 3 and blood sample at the specified timepoint. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 3.5 (1 month post-Dose 3 of IPV) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab | Analysis was performed on the PPS for IPV. Only participants with data available at the specified timepoints were included in the analysis. | Posted | Mean | 95% Confidence Interval | Titers | At Month 3.5 (1 month post-Dose 3 of IPV) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 | Analysis was performed on the PPS for IPV. Only participants with data available at the specified timepoints were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 3.5 (1 month post-Dose 3 of IPV) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Analysis was performed on the PPS for RV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-RV IgA analyses at 1 month post Dose 2 of HRV PCV-free, participants should have pre- and post-vaccination immunogenicity results and should have complied with the interval between HRV Dose 2 and the post HRV PCV-free Dose 2 blood sample at the specified timepoint. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab | Analysis was performed on the PPS for RV. Only participants with data available at the specified timepoints were included in the analysis. | Posted | Mean | 95% Confidence Interval | U/mL | At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL | Analysis was performed on the PPS for RV. Only participants with data available at the specified timepoints were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any Solicited Systemic Events | Solicited systemic events include cough/runny nose, diarrhoea, fever (pyrexia), irritability/fussiness, loss of appetite and vomiting. 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 who received at least one dose of any of the 2 study interventions and for whom solicited systemic events data were available after the corresponding vaccination for the specified timepoint. | Posted | Count of Participants | Participants | Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any 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 who received at least one dose of any of the 2 study interventions and for whom unsolicited AEs data were available after the corresponding vaccination for the specified timepoint. | Posted | Count of Participants | Participants | Within 31 days after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any 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. 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 who received at least one dose of any of the 2 study interventions and for whom SAE data were available after the corresponding vaccinations for the specified duration. | Posted | Count of Participants | Participants | 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) |
|
Solicited AEs: Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group), Unsolicited AEs: Within 31 days after each dose of HRV PCV-free vaccine. All-cause mortality and SAEs were collected throughout the study period (From Day 1 to Month 3.5).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Staggered Group | Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5. | 0 | 199 | 30 | 199 | 141 | 199 |
| EG001 | Co-administration Group | Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV 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. | 0 | 193 | 30 | 193 | 129 | 193 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Pneumonia escherichia | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | v27.1 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | v27.1 | Systematic Assessment |
| |
| Secondary thrombocytosis | Blood and lymphatic system disorders | v27.1 | Systematic Assessment |
| |
| Pelvi-ureteric obstruction | Renal and urinary disorders | v27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | v27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | v27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | v27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | v27.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | v27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | v27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | v27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | v27.1 | Systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | v27.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | v27.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | v27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | v27.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | v27.1 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | v27.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | v27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | v27.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | v27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | v27.1 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | v27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | v27.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | v27.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | v27.1 | Systematic Assessment |
| |
| Eczema infantile | Skin and subcutaneous tissue disorders | v27.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | v27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | v27.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | v27.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | v27.1 | Systematic Assessment |
| |
| Myocardial necrosis marker increased | Investigations | v27.1 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | v27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | v27.1 | Systematic Assessment |
| |
| Ureteric dilatation | Renal and urinary disorders | v27.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | v27.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | v27.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | v27.1 | Systematic Assessment |
| |
| Testicular swelling | Reproductive system and breast disorders | v27.1 | 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 | Oct 21, 2024 | Oct 1, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Male |
|
| anti-poliovirus serotype3 |
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| To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5). | Difference in seroconversion rate | -0.70 | 2-Sided | 95 | -3.86 | 2.30 | The asymptotic standardized 95% CI for the difference in seroconversion rate for IPV at month 3.5 between Co-administration group minus staggered group is computed using the method of Miettinen and Nurminen. | Non-Inferiority | NI was to be demonstrated if the LL of the 2-sided 95% CI for the group difference (Co-administration group minus Staggered group) in seroconversion rate is >= -10% for the anti-poliovirus type 2 antibodies. |
| To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5). | Difference in seroconversion rate | 0.00 | 2-Sided | 95 | -2.63 | 2.99 | The asymptotic standardized 95% CI for the difference in seroconversion rate for IPV at Month 3.5 between Co-administration group minus Staggered group is computed using the method of Miettinen and Nurminen. | Non-Inferiority | NI was to be demonstrated if the LL of the 2-sided 95% CI for the group difference (Co-administration group minus Staggered group) in seroconversion rate is >= -10% for the anti-poliovirus type 3 antibodies. |
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