Rotavirus Gastroenteritis
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subjects who the investigator believed that their parents/guardians could and would comply with the requirements of the protocol (e.g. completion of the diary cards, returned for the follow-up visits) were enrolled in the study. -A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination. -Written informed consent obtained from the parents/guardians of the subject -Documented HIV status of the subject as confirmed by PCR. -HIV asymptomatic and HIV mildly symptomatic; Stage I and II disease according to WHO’s most recent classifi-cation for HIV stages in infants and children [30 Revised WHO clinical staging of HIV/AIDS for infants and children and 21 Guidelines for the management of HIV-infected children, 2005 or latest updated version]. -Born after a gestation period of 36 to 42 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: 100 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 drug or vac-cine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. -Previous routine vaccination except OPV, BCG and HBV vaccination at birth (should have been documented in the CRF). -Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator. -History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. -Acute disease at time of enrolment. (Acute disease was defined as the presence of moderate or severe illness with fever i.e. temperature more than or equal to 38.0°C (more than or equal to 37.5°C) as measured by a rectal (axillary) thermometer) (warrants deferral of the vaccination). -Gastroenteritis (diarrhoea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). -Previous confirmed occurrence of RV gastroenteritis. -Other conditions which in the opinion of the investigator might have potentially interfered with interpretation of study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and reactogenicity of 3 doses of GSK Biologicals’ HRV vaccine versus placebo in HIV infected infants.;Secondary Objective: To assess the immunogenicity (Geometric mean concentration (GMC), seroconversion, vaccine take) of the HRV vaccine in HIV infected infants two months after the third dose. To assess rotavirus shedding until it stops in HIV infected infants. To assess enteric pathogens in diarrhoeal stools. To assess the immune deficiency status (HIV viral load and CD4+ cell counts). To assess the immunogenicity of routine vaccines (DTPw-HBV/Hib + OPV) two months after the third dose. ;Primary end point(s): Occurrence of grade “2” or grade “3” fever, vomiting or diarrhoea within the 15-day solicited follow-up period after any doses.;Timepoint(s) of evaluation of this end point: Within 15 day after each dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reactogenicity: For each type of solicited symptoms, occurrence of the symptom within the 15-day solicited follow-up period after each dose. Occurrence of unsolicited symptoms within 31 days after any dose according to MedDRA classification. Occurrence of SAEs throughout the study period. Evaluation of immune deficiency condition: CD4+ cell count HIV Viral load Immunogenicity: Seroconversion rate defined as the percentage of subjects with anti-rotavirus IgA antibody concentration greater than or equal to 20 U/ml in subjects initially negative for RV. Vaccine take rate (seroconversion or vaccine shedding) Serum rotavirus IgA antibody concentrations. GMC/Ts for anti-PRP, anti-diphtheria and anti-tetanus toxoids, anti-BPT, anti-HBs and anti-polio types 1, 2 and 3 antibodies. Seroprotection status: anti-PRP antibody concentrations more than or equal to 0.15 and 1.0 mcg/ml anti-diphtheria toxoid antibody concentrations more than or equal to 0.1 IU/ml anti-tetanus toxoid antibody concentrations more than or equal to 0.1 IU/ml anti-HBs antibody concentrations more than or equal to 10.0 mIU/ml anti-polio types 1, 2 and 3 antibody titres more than or equal to 8 Seropositivity status: anti-BPT antibody concentrations 15 EL U/ml above the cut off level of the assay used RV shedding in stool samples by ELISA. RV typing and RV vaccine strain identification if G1 is identified (if applicable) Rotavirus in stool samples by ELISA. RV vaccine strain identification if applicable Bacteriology for enteric pathogens. ;Timepoint(s) of evaluation of this end point: Solicited symptoms: 15 day follow-up after each dose, Unsolicited: 31 day follow-up after each dose, SAE's: Throughout the study period (Day 0-more than or equal to Month 4+7 days), CD4 count and HIV viral load: At the screening visit and Visit 4 (Month 4), Seroconversion rate, vaccine take rate and Serum rotavirus IgA antibody concentrations: 2 months after the 3rd dose o | — |
Countries
South Africa
Contacts
Public ContactClinical disclosure advisor
GlaxoSmithKline Biologicals
Outcome results
None listed