Healthy volunteers
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. •A male or female between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo (parents must be able to provide a copy of birth certificate of the subject). •Birth weight of the subject should be > 2000 grams. •Written informed consent obtained from the parent or guardian of the subject. •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: 375 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: •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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For cor-ticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) •Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. BCG is administered at birth according to the local EPI. However, it can be administered at Visit 1. •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). •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo. •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).Temperature greater than or equal to this cut-off warrants deferral of the vaccination pending recovery of the subject. •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunogenicity of GSK Biologicals’ HRV liquid vaccine versus placebo, in terms of anti-rotavirus Immunoglobulin A (IgA) antibody seroconversion at Month 3 (i.e. Visit 4), when administered concomitantly with the second and third routine EPI immunization;Primary end point(s): Anti-RV IgA antibody seroconversion, when administered concomitantly with the second and third routine EPI immunization;Timepoint(s) of evaluation of this end point: Month 3 (i.e. Visit 4);Secondary Objective: •To assess immunogenicity of GSK Biologicals’ HRV liquid vaccine versus placebo, in terms of anti-RV IgA antibody seroconversion at Month 3 (i.e. Visit 4), when administered concomitantly with the first and third routine EPI immunization. •To assess immunogenicity of GSK Biologicals’ HRV liquid vaccine in terms of anti-RV IgA geometric mean concentrations (GMCs) at Month 3 (i.e. Visit 4), when administered concomitantly with the second and third routine EPI immunization. •To assess immunogenicity of GSK Biologicals’ HRV liquid vaccine, in terms of anti-RV IgA GMC at Month 3 (i.e. Visit 4), when administered concomitantly with the first and third routine EPI immunization. •To assess the safety and reactogenicity of each dose of GSK Biologicals’ HRV liquid vaccine versus placebo. •To assess the presence of RV in GE stools collected after administration of first dose (i.e. Visit 1) of GSK Biologicals’ HRV liquid vaccine or placebo, up to Visit 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Anti-RV IgA antibody seroconversion, when administered concomitantly with the first and third routine EPI immunization Serum anti-RV IgA antibody concentration Occurrence of grade “2” or grade “3” fever, vomiting or diarrhea. For each type of solicited symptom, occurrence of the symptom. Occurrence of unsolicited adverse events, according to Medical Dictionary for Regulatory Activities (MedDRA) classification Occurrence of serious adverse events (SAEs) Presence of RV in GE stools collected.;Timepoint(s) of evaluation of this end point: Immunogenicity: At Month 3 (i.e. Visit 4) Fever etc: Within the 8-day solicited follow-up period (Day 0-Day 7) after each dose of HRV liquid vaccine or placebo Solicited symptoms: Within the 8-day solicited follow-up period after each dose of HRV liquid vaccine or placebo (Day 0-Day 7) Unsolicited symptoms: Within 31 days after any doses of HRV liquid vaccine or placebo (Day 0-Day 30) SAEs: Throughout the study period. RV GE in stools: At Visit 1 | — |
Countries
Philippines
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed