| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (active immunization of infants against gastroenteritis due to rotavirus infection) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Rotavirus is a contagious virus that causes diarrhea and other intestinal symptoms among infants and young children. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| - To demonstrate the immunological non-inferiority of IPV when co-administered with Rotarix PCV-free compared with IPV administered alone. |
|
| E.2.2 | Secondary objectives of the trial |
- To evaluate the immunogenicity of IPV when co-administered with Rotarix PCV-free and when administered alone.
- To evaluate the immunogenicity of Rotarix PCV-free when co-administered with IPV and when administered alone.
- To evaluate the reactogenicity of Rotarix PCV-free and IPV in terms of solicited systemic events.
- To assess the safety of Rotarix PCV-free in terms of unsolicited adverse events (AEs) and serious adverse events (SAEs) and safety of IPV in terms of SAEs.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Participants’ parent(s)/Legally Acceptable Representative(s) (LAR), who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- Healthy participants as established by medical history and clinical examination before entering into the study.
- A male or female of Chinese origin, between and including, 6 and 10 weeks (42-76 days) of age at the time of study enrolment.
- Born after a gestation period of 36 to 42 weeks inclusive. |
|
| E.4 | Principal exclusion criteria |
Medical conditions
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Hypersensitivity to latex.
- History of severe combined immunodeficiency.
- History of seizures or progressive neurological disease.
- Family history of congenital or hereditary immunodeficiency.
- Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS).
- History of IS.
- Major congenital defects, or serious chronic illness as assessed by the investigator.
- Any contraindications to IPV.
- Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).
- History of poliomyelitis.
- Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19).
Prior/Concomitant therapy
- Use of any investigational or non-registered product) other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study interventions administration*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
- Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period.
- Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled, intra-articular and topical steroids are allowed.
- Previous vaccination against RV.
- Previous vaccination against poliomyelitis.
Prior/Concurrent clinical study experience
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
Other exclusions
- Child in care. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab)
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| At 1 month post Dose 3 of IPV (Month 3.5) |
|
| E.5.2 | Secondary end point(s) |
A. Anti-poliovirus types 1, 2 and 3 neutralizing Ab geometric mean titers (GMTs)
B. Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64
C. Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab
D. Anti-RV IgA Ab geometric mean concentrations (GMCs)
E. Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL
F. Percentage of participants reporting solicited systemic events
G. Percentage of participants reporting unsolicited adverse events (AEs)
H. Percentage of participants reporting serious adverse events (SAEs)
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
A, B. At 1 month post Dose 3 of IPV (Month 3.5)
C, D, E. At 1 month post Dose 2 of PCV-free liquid formulation of GSK’s oral live attenuated HRV (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
F. Within 14 days after Dose 1 and Dose 2 of PCV-free liquid formulation of GSK’s oral live attenuated HRV and IPV study interventions administration
G. Within 31 days after each dose of PCV-free liquid formulation of GSK’s oral live attenuated HRV study intervention administration
H. 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) |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| EoS is defined as last subject last visit (LSLV) (Visit 7) or date of the last testing/reading released of the Human Biological Samples, related to primary and secondary endpoints, whichever occurs later. EoS must be achieved no later than 8 months after LSLV. EoS cannot be before LSLV. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 19 |
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