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 Rotarix PCV-free as compared to Rotarix in terms of seroconversion rates 1 month post Dose 2. - To demonstrate the non-inferiority of Rotarix PCV free as compared to Rotarix in terms of serum anti-rotavirus immunoglobulin A (RV IgA) antibody (Ab) concentrations 1 month post Dose 2.
|
|
E.2.2 | Secondary objectives of the trial |
- To assess the immunological non-inferiority of Rotarix PCV-free as compared to Rotarix in terms of percentage of participants with anti-RV IgA antibody concentrations >=90 unit per milliliter (U/mL) 1 month post Dose 2. - To evaluate the reactogenicity of Rotarix PCV-free and Rotarix in terms of solicited systemic events. - To assess the safety of Rotarix PCV-free and Rotarix in terms of unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants’ parent(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.
|
|
E.4 | Principal 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 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Outcome measure title Percentage of seroconverted participants for anti-rotavirus (RV) immunoglobulin A (IgA) antibody (Ab) 2. Serum anti-RV IgA Ab concentrations expressed as geometric mean concentrations (GMCs) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. At Month 2 (1 month post Dose 2) 2. At Month 2 (1 month post Dose 2) |
|
E.5.2 | Secondary end point(s) |
1. Percentage of participants with serum anti-RV IgA Ab concentrations >= 90 U/mL 2. Percentage of participants reporting solicited systemic events 3. Percentage of participants reporting unsolicited adverse events (AEs) 4. Percentage of participants reporting serious adverse events (SAEs) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. At Month 2 (1 month post Dose 2) 2. Within 14 days after each study intervention administration occurring at Day 1 and Month 1 3. Within 31 days after each study intervention administration occurring at Day 1 and Month 1 4. From Dose 1 (Day 1) of the study intervention up to study end (Month 7)
|
|
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 |
Immunogenicity Reactogenicity
|
|
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
This study will be conducted in an observer-blin |
|
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 contact (Month 7). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |