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.

The analysis was performed on the Total Vaccinated Cohort which included the vaccinated subjects for whom data were available.

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.

Analysis was performed on the Total Vaccinated Cohort.

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.

Analysis was performed on the Total Vaccinated Cohort.

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.

Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available and who had their symptom sheets completed.

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.

Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.

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).

Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.

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.

Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available.

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.

Analysis was performed on subjects from the According To Protocol Cohort for immunogenicity for whom data were available.

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

The analysis was performed on the According To Protocol Cohort for immunogenicity for whom data were available. In the Placebo group, GMCs were all < 20 U/ml, hence values were not computed.

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

The analysis was performed on the According To Protocol Cohort for immunogenicity.

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

The analysis was performed on the According to Protocol cohort for immunogenicity.

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

The analysis was performed on the According To Protocol cohort for immunogenicity.

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

The analysis was performed on the According to Protocol cohort for immunogenicity.

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

The analysis was performed on the According To Protocol cohort for immunogenicity.

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

The analysis was performed on the According to Protocol cohort for immunogenicity.

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

The analysis was performed on the According To Protocol cohort for immunogenicity.

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

The analysis was performed on the According to Protocol cohort for immunogenicity.

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.

The analysis was performed on the According To Protocol cohort for immunogenicity.

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

The analysis was performed on the According To Protocol cohort for immunogenicity.

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

The analysis was performed on the According to Protocol Cohort for immunogenicity.

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

Analysis was performed on the Total Vaccinated Cohort

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.

Analysis was performed on the Total Vaccinated Cohort.

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

The analysis was performed on the subjects from the Total Vaccinated Cohort with gastroenteritis episodes reported between the first dose and the last visit and for whom stools were collected.

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]).

Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available.