Rotarix is indicated to prevent infants against gastroenteritis (GE) due to rotavirus (RV). MedDRA version: 19.0 Level: LLT Classification code 10039232 Term: Rotavirus gastroenteritis System Organ Class: 100000004862
Conditions
Interventions
Product Name: HRV PCV-free liquid vaccine
Product Code: HRV PCV-free liquid vaccine
Pharmaceutical Form: Oral suspension
INN or Proposed INN: -
Other descriptive name: HUMAN ROTAVIRUS RIX4414 STRAIN (
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects’ parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol. •Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. •A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination. •Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days). •Healthy subjects as established by medical history and clinical examination before entering into the study. Are the trial subjects under 18? yes Number of subjects for this age range: 1600 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Child in care •Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), or planned use during the study period. •Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed. •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. •Administration of long-acting immune-modifying drugs at any time 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 of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations. •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. •Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS). •History of IS. •Family history of congenital or hereditary immunodeficiency. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. •Major congenital defects or serious chronic illness. •Previous vaccination against RV. •Previous confirmed occurrence of RVGE. •GE within 7 days preceding the study vaccine administration. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. •Hypersensitivity to latex. •Acute disease and/or fever at the time of enrolment. -Fever is defined as temperature = 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum. -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate the lot-to-lot consistency of the PCV-free liquid HRV vaccine in terms of immunogenicity as measured by serum anti-RV IgA antibody concentrations 1-2 months after Dose 2. •To demonstrate the immunological non-inferiority of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine in terms of seroconversion rates 1-2 months after Dose 2. •To demonstrate the non-inferiority of the PCV-free liquid HRV vaccine to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2. ;Secondary Objective: Reactogenicity and safety •To evaluate the reactogenicity of the liquid HRV vaccine and currently licensed lyophilised HRV vaccine in terms of solicited AEs during the 8 days (Day 0-Day 7) follow-up period after each vaccination. •To assess the safety of the study vaccines in terms of unsolicited AEs during the 31 days (Day 0-Day 30) follow-up period after each vaccination and Serious Adverse Events (SAEs) during the entire study period. Immunogenicity •To assess the immunogenicity of the PCV-free liquid HRV vaccine and the currently licensed lyophilised HRV vaccine, in terms of percentage of subjects with anti-RV IgA antibody concentrations = 90 U/mL 1-2 months after Dose 2.;Primary end point(s): Evaluation of immunogenicity in terms of anti-RV antibody concentrations. -Serum anti-RV IgA antibody concentrations expressed as GMCs in each of the HRV liquid formulation groups (Liq_A, Liq_B and Liq_C). -Anti-RV IgA antibody seroconversion rate* in the lyophilised and pooled liquid groups. -Serum anti-RV IgA antibody concentrations expressed as GMCs in the lyophilised and pooled liquid groups. *Seroconversion rate is defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration < 20 U/mL prior the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration = 20 U/mL at Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of subjects with solicited adverse events. 2. Number of subjects with unsolicited adverse events. 3. Number of subjects with serious adverse events. 4. Number of subjects with serum anti-RV IgA antibody concentrations = 90 U/mL in the lyophilised and pooled liquid groups.;Timepoint(s) of evaluation of this end point: 1. Within the 8 days (Day 0-Day 7) follow-up period 2. Within 31 days (Day 0-Day 30) after any dose of HRV vaccine 3. Dose 1 up to the study end 4. 1-2 months after Dose 2 | — |
Countries
Costa Rica, Finland, Germany, Japan, Korea, Democratic People's Republic of, Spain, Taiwan, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed