A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa

Symptoms reported in the table include: Fever: temperature (axillary route) > 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day.

An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Solicited symptoms included Cough, Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5°C), Irritability, Loss of appetite, and Vomiting.

Severe suppression: CD4+ cells/microliter (μl) < 750 and CD4+ percent < 15 percent (%); No evidence of suppression: CD4+ cells/μl ≥ 1500 and CD4+ percent ≥ 25%; Moderate suppression = all other CD4+ cell count and CD4+ % combinations.

The HIV viral load was expressed as mean and standard deviation of the base-10 logarithm of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL).

A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.

Vaccine take: appearance of serum IgA to rotavirus at a concentration of ≥ 20 U/ml or rotavirus shedding in any stool sample collected from the Screening Visit to 2 months after dose 3 for subjects initially negative for rotavirus.

Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.

Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL).

Anti-PRP antibody concentrations are presented as geometric mean concentrations, expressed in microgram/milliliter (μg/mL).

The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL).

Anti-diphteria and anti-tetanus toxoids antibody concentrations are presented as geometric mean concentrations, expressed in international units/milliliter (IU/mL).

The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).

Anti-HBs antibody concentrations are presented as geometric mean concentrations, expressed in milli international units/milliliter (mIU/mL).

The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter (EL.U/mL).

Anti-BPT antibody concentrations are presented as geometric mean concentrations, expressed in ELISA units/milliliter (EL.U/mL).

The cut-off value was ≥ 1:8. The lowest dilution at which serum samples were tested was 1:8, from which a test was considered positive.

Anti-polio types 1, 2 and 3 antibody titers are presented as geometric mean titers.

Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end.

Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode.

Number of gastroenteritis (GE) episodes classified by rotavirus vaccine strain/serotype. Unknown: These samples were typed post hoc and found "G1P8" vaccine type for one subject in HRV group, "G3P8" and "G2P4" for subjects in placebo group.

Number of subjects reporting gastroenteritis (GE) episodes classified by enteric pathogen tests results.

Number of subjects with presence of RV in stool samples (shedding) collected at pre-determined time points by RV type (Yes, No, Mixed type = G1V+G1WT+G2+G3+P4+P8V+P8WT and results not available [NA]).