A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
Trial overview
Number of subjects reporting grade “2” or grade “3” fever, vomiting or diarrhea
Timeframe: Within the 15-day solicited follow-up period after any dose
Number of subjects reporting any unsolicited symptoms
Timeframe: Within 30 days after any dose
Number of subjects reporting any serious adverse events
Timeframe: Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3)
Number of subjects reporting each type of solicited symptom
Timeframe: Within the 15-day solicited follow-up period after each dose
The number of subjects with no evidence of immunosuppression and moderate/ severe suppression, based on CD4+ absolute cell count and CD4+ percent
Timeframe: At the screening visit and 2 months after dose 3 (Visit 4)
Human immunodeficiency virus (HIV) Viral load
Timeframe: At the screening visit and 2 months after dose 3
Number of subjects who seroconverted against rotavirus
Timeframe: Two months after dose 3
Number of subjects with vaccine take
Timeframe: Two months after dose 3
Serum rotavirus immunoglobulin A (IgA) antibody concentrations
Timeframe: Two months after dose 3
Number of subjects with anti-polyribosyl ribitol phosphate (PRP) antibody concentrations more than or equal to the cut-off value
Timeframe: Two months after dose 3
Geometric Mean Concentration for anti-PRP antibodies
Timeframe: Two months after dose 3
Number of subjects with anti-diphtheria and anti-tetanus toxoids antibody concentrations more than or equal to the cut-off value
Timeframe: Two months after dose 3
Geometric Mean Concentration for anti-diphtheria and anti-tetanus toxoids antibodies
Timeframe: Two months after dose 3
Number of subjects with anti-hepatitis B (HBs) antibody concentrations more than or equal to the cut-off value
Timeframe: Two months after dose 3
Geometric Mean Concentration for anti-HBs antibodies
Timeframe: Two months after dose 3
Number of subjects with anti-Bordetella pertussis (BPT) antibody concentrations more than or equal to the cut-off value
Timeframe: Two months after dose 3
Geometric Mean Concentration for anti-BPT antibodies
Timeframe: Two months after dose 3
Number of subjects with anti-polio types 1, 2 and 3 antibody titers more than or equal to the cut-off value
Timeframe: Two months after dose 3
Geometric Mean Titer for anti-polio types 1, 2 and 3 antibodies.
Timeframe: Two months after dose 3
Rotavirus antigen excretion in stool samples
Timeframe: At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding
Rotavirus in diarrheal stool samples
Timeframe: From Dose 1 until 2 months after dose 3 or until end of RV shedding
Rotavirus vaccine strain identification
Timeframe: From dose 1 until 2 months after dose 3 or until end of RV shedding
Enteric pathogens identification
Timeframe: From Dose 1 until 2 months after dose 3 or until end of RV shedding
Number of subjects with the RV in stool samples
Timeframe: From Dose 1 until post Dose 3
Participation criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination.
- Use of any investigational or non-registered drug or vaccine 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
- 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 or guardians of the subject
- Documented HIV status of the subject as confirmed by PCR.
- HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
- Born after a gestation period of 36 to 42 weeks.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Previous routine vaccination except OPV, BCG and HBV vaccination at birth
- 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.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Previous confirmed occurrence of RV gastroenteritis.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.