Healthy volunteers (Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV))
Conditions
Interventions
Trade Name: Rotarix Oral Suspension
Pharmaceutical Form: Oral suspension
INN or Proposed INN: -
Other descriptive name: HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
Concentration unit: log10 CCID5
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believed that their parents/ Legally Acceptable Representative(s) (LARs could) can and wouldwill comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit). •A male or female infant of Chinese origin between, and including, 6 and 16 weeks (42–112 days) of age at the time of the first vaccination. •Written informed consent was obtained from the parents/LARs of the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study. •Born after a gestation period of 36 to 42 weeks inclusive. Are the trial subjects under 18? yes Number of subjects for this age range: 50 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) of immunosuppressants or other immune-modifying drugs since birth (for corticosteroids, this meant prednisone, > or equivalent to 0.5 mg/kg/day. Inhaled and topical steroids were allowed). •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the HRV vaccine or placebo except for the routine childhood vaccinations (i.e. DTP and OPV). •Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS). •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •A family history of congenital or hereditary immunodeficiency. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. •Major congenital defects or serious chronic illness. •Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe ill-ness with or without fever. The vaccine could be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature < 37.1°C as defined by the Chinese authorities). Temperature greater than or equal to this cut-off warranted deferral of the vaccination pending recovery of the subject. •History of confirmed RV GE. •GE within 7 days preceding the study vaccine or placebo administration (warranted deferral of the vaccination). •Previous vaccination with RV vaccine or planned to use during the study period. •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. •Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the reactogenicity of GSK Biologicals’ liquid HRV vaccine when compared to placebo in terms of grade “3” solicited adverse events (AEs).;Secondary Objective: •To assess the reactogenicity of GSK Biologicals’ liquid HRV vaccine when compared to placebo in terms of solicited AEs. •To assess the safety of GSK Biologicals’ liquid HRV vaccine when compared to placebo in terms of unsolicited AEs and serious adverse events (SAEs). ;Primary end point(s): Occurrence of solicited AEs (grade “3”) ;Timepoint(s) of evaluation of this end point: Within the 8-day (Day 0 to Day 7) follow-up period after each dose of liquid HRV vaccine or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of each solicited AE. Occurrence of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. Occurrence of serious adverse events (SAEs), according to the MedDRA classification. ;Timepoint(s) of evaluation of this end point: Solicited AEs: Within the 8-day (Day 0 to Day 7) follow-up period after each dose of liquid HRV vaccine or placebo. Unsolicited AEs: Within the 31-day (Day 0 to Day 30) follow-up after any dose of liquid HRV vaccine or placebo. SAEs: Throughout the study period after Dose 1 of the liquid HRV vaccine or placebo (Approximately 2 months) | — |
Countries
China
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed