Healthy volunteers (Two-dose primary vaccination at 2 and 4 months of age in healthy infants previously unin-fected with HRV infection)
Conditions
Interventions
Trade Name: Rotarix
Product Code: HRV
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: -
Other descriptive name: HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
Concen
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit). •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. •Written informed consent obtained from the parent(s)/LAR(s) of the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study. •Infants who have received a previous dose of hepatitis B immunoglobulin after birth. Are the trial subjects under 18? yes Number of subjects for this age range: 15 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 (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs with the exception of HBIG since birth. For corticosteroids, prednisone >20 mg/day, or equivalent, inhaled and topical steroids are allowed. •Child is unlikely to remain in the study area for the duration of the study. •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine. •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 product (pharmaceutical product or device). •Previous vaccination against RV. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •Family history of congenital or hereditary immunodeficiency. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. •Major congenital defects or serious chronic illness. •Acute disease and/or fever at the time of enrolment. -Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting, or = 38.0°C (100.4°F) on rectal setting. The preferred route for recording temperature in this study will be tympanic on rectal setting. -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. •Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period. •GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). •Previous confirmed occurrence of RV GE.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunogenicity of GSK Biologicals' HRV vaccine in terms of serum anti-rotavirus IgA antibody seroconversion rate, 2 months post-Dose 2 (i.e. at Visit 3) of the HRV vaccine.;Secondary Objective: •To assess the immunogenicity of GSK Biologicals' HRV vaccine in terms of serum anti-rotavirus IgA antibody concentrations 2 months post-Dose 2 (i.e. at Visit 3) of the HRV vaccine •To assess the reactogenicity of GSK Biologicals' HRV vaccine in terms of occurrence of solicited adverse events (AEs) within the 8-day (Day 0 to Day 7) follow-up period after each dose of the HRV vaccine. •To assess the safety of GSK Biologicals' HRV vaccine in terms of unsolicited AEs within 31 days after any dose of the HRV vaccine and SAEs, from Dose 1 of the HRV vaccine up to Visit 3 (Month 4). •To assess the presence of RV in gastroenteritis (GE) stools collected from Dose 1 of HRV vaccine up to Visit 3 (Month 4).;Primary end point(s): Anti-rotavirus IgA antibody seroconversion rate Serum anti-RV IgA antibody seroconversion rate ;Timepoint(s) of evaluation of this end point: At two months post-Dose 2 of the HRV vaccine (i.e. at Visit 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Serum anti-rotavirus IgA antibody concentrations. Serum anti-rotavirus IgA antibody concentrations ex-pressed as geometric mean concentration (GMC) Occurrence of each solicited symptom . Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. Occurrence of SAEs. Presence of RV in GE stools. ;Timepoint(s) of evaluation of this end point: Immunogenicity: At two months post Dose 2 of the HRV vaccine (i.e. at Visit 3) Solicited symptoms: Within the 8-day (Day 0 to Day 7) follow-up period after each dose of the HRV vaccine Unsolicited symptoms: Within the 31-day (Day 0 to Day 30) follow-up period after any dose of HRV vaccine SAEs: Throughout the study period following Dose 1 of the HRV vaccine (Day 0 to Month 4) RV in stools: After administration of first dose (i.e. at Visit 1) of HRV vaccine up to Visit 3 | — |
Countries
Taiwan
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed