Infections, Rotavirus
Conditions
Brief summary
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
HIV infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation) vaccinations will be administered concomitantly with the study vaccines. At the time of first dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine relative to the placebo.
Interventions
BIOLOGICALRotarix
Oral vaccination
BIOLOGICALPlacebo
Oral administration
BIOLOGICALTritanrix-HB+Hib
Concomitant routine vaccination, IM administration
BIOLOGICALPolio Sabin
Oral administration, concomitant routine vaccination
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study was conducted in a double-blind manner. The parents/guardians of the subjects and the study personnel were unaware of the administered treatment (HRV vaccine or placebo).
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 10 Weeks
Healthy volunteers
No
Inclusion 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. * 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.
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea | Within the 15-day solicited follow-up period after any dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration for Anti-HBs Antibodies | Two months after dose 3 | Anti-HBs antibody concentrations are presented as geometric mean concentrations, expressed in milli international units/milliliter (mIU/mL). |
| Number of Subjects Reporting Any Unsolicited Symptoms | Within 30 days after any dose | 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. |
| Number of Subjects Reporting Any Serious Adverse Events | 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) | 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. |
| Number of Subjects Reporting Each Type of Solicited Symptom | Within the 15-day solicited follow-up period after each dose | 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. |
| The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | At the screening visit and 2 months after dose 3 (Visit 4) | 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. |
| Human Immunodeficiency Virus (HIV) Viral Load | At the screening visit and 2 months after dose 3 | 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). |
| Number of Subjects Who Seroconverted Against Rotavirus | Two months after dose 3 | 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. |
| Number of Subjects With Vaccine Take | Two months after dose 3 | 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. |
| Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations | Two months after dose 3 | Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies. |
| Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value | Two months after dose 3 | Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL). |
| Geometric Mean Concentration for Anti-PRP Antibodies | Two months after dose 3 | Anti-PRP antibody concentrations are presented as geometric mean concentrations, expressed in microgram/milliliter (μg/mL). |
| Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value | Two months after dose 3 | The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL). |
| Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies | Two months after dose 3 | Anti-diphteria and anti-tetanus toxoids antibody concentrations are presented as geometric mean concentrations, expressed in international units/milliliter (IU/mL). |
| Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value | Two months after dose 3 | The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter (EL.U/mL). |
| Geometric Mean Concentration for Anti-BPT Antibodies | Two months after dose 3 | Anti-BPT antibody concentrations are presented as geometric mean concentrations, expressed in ELISA units/milliliter (EL.U/mL). |
| Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value | Two months after dose 3 | 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. |
| Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. | Two months after dose 3 | Anti-polio types 1, 2 and 3 antibody titers are presented as geometric mean titers. |
| Rotavirus Antigen Excretion in Stool Samples | 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 | Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end. |
| Rotavirus in Diarrheal Stool Samples | From Dose 1 until 2 months after dose 3 or until end of RV shedding | Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode. |
| Rotavirus Vaccine Strain Identification | From dose 1 until 2 months after dose 3 or until end of RV shedding | 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. |
| Enteric Pathogens Identification | From Dose 1 until 2 months after dose 3 or until end of RV shedding | Number of subjects reporting gastroenteritis (GE) episodes classified by enteric pathogen tests results. |
| Number of Subjects With the RV in Stool Samples | From Dose 1 until post Dose 3 | 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 \[NA\]). |
| Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value | Two months after dose 3 | The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL). |
Countries
South Africa
Participant flow
Pre-assignment details
In case of discrepancy between the HIV results (DNA PCR positive, viral load negative), performed at the Screening Visit (one week prior to first vaccination) the infants were not enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines. | 50 |
| Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 8 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Rotarix Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 7.1 weeks STANDARD_DEVIATION 1.1 | 6.9 weeks STANDARD_DEVIATION 1.02 | 7.0 weeks STANDARD_DEVIATION 1.06 |
| Sex: Female, Male Female | 28 Participants | 25 Participants | 53 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 50 | 9 / 50 |
| other Total, other adverse events | 48 / 50 | 47 / 50 |
| serious Total, serious adverse events | 17 / 50 | 12 / 50 |
Outcome results
Primary
Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea
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.
Time frame: Within the 15-day solicited follow-up period after any dose
Population: The analysis was performed on the Total Vaccinated Cohort which included the vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea | 26 Participants |
| Placebo Group | Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea | 28 Participants |
Secondary
Enteric Pathogens Identification
Number of subjects reporting gastroenteritis (GE) episodes classified by enteric pathogen tests results.
Time frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotarix Group | Enteric Pathogens Identification | Campylobacter, negative | 18 Participants |
| Rotarix Group | Enteric Pathogens Identification | Campylobacter, positive | 0 Participants |
| Rotarix Group | Enteric Pathogens Identification | Campylobacter, unknown | 11 Participants |
| Rotarix Group | Enteric Pathogens Identification | E. histolytica, negative | 18 Participants |
| Rotarix Group | Enteric Pathogens Identification | E. histolytica, positive | 0 Participants |
| Rotarix Group | Enteric Pathogens Identification | E. histolytica, unknown | 11 Participants |
| Rotarix Group | Enteric Pathogens Identification | Salmonella, negative | 17 Participants |
| Rotarix Group | Enteric Pathogens Identification | Salmonella, positive | 1 Participants |
| Rotarix Group | Enteric Pathogens Identification | Salmonella, unknown | 11 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Epec, negative | 3 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Epec, positive | 0 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Epec, unknown | 26 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto G.Lamblia, negative | 18 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto G.Lamblia, positive | 0 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto G.Lamblia, unknown | 11 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Shigella, negative | 18 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Shigella, positive | 0 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Shigella, unknown | 11 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Yersinia, negative | 18 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Yersinia, positive | 0 Participants |
| Rotarix Group | Enteric Pathogens Identification | Sto Yersinia, unknown | 11 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Epec, positive | 0 Participants |
| Placebo Group | Enteric Pathogens Identification | Campylobacter, negative | 24 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Yersinia, negative | 24 Participants |
| Placebo Group | Enteric Pathogens Identification | Campylobacter, positive | 0 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Epec, unknown | 29 Participants |
| Placebo Group | Enteric Pathogens Identification | Campylobacter, unknown | 10 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Shigella, positive | 0 Participants |
| Placebo Group | Enteric Pathogens Identification | E. histolytica, negative | 24 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto G.Lamblia, negative | 24 Participants |
| Placebo Group | Enteric Pathogens Identification | E. histolytica, positive | 0 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Yersinia, unknown | 10 Participants |
| Placebo Group | Enteric Pathogens Identification | E. histolytica, unknown | 10 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto G.Lamblia, positive | 0 Participants |
| Placebo Group | Enteric Pathogens Identification | Salmonella, negative | 24 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Shigella, unknown | 10 Participants |
| Placebo Group | Enteric Pathogens Identification | Salmonella, positive | 0 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto G.Lamblia, unknown | 10 Participants |
| Placebo Group | Enteric Pathogens Identification | Salmonella, unknown | 10 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Yersinia, positive | 0 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Epec, negative | 5 Participants |
| Placebo Group | Enteric Pathogens Identification | Sto Shigella, negative | 24 Participants |
Secondary
Geometric Mean Concentration for Anti-BPT Antibodies
Anti-BPT antibody concentrations are presented as geometric mean concentrations, expressed in ELISA units/milliliter (EL.U/mL).
Time frame: Two months after dose 3
Population: The analysis was performed on the According to Protocol cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Rotarix Group | Geometric Mean Concentration for Anti-BPT Antibodies | 28.8 ELISA-Units/milliliter |
| Placebo Group | Geometric Mean Concentration for Anti-BPT Antibodies | 18.1 ELISA-Units/milliliter |
Secondary
Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies
Anti-diphteria and anti-tetanus toxoids antibody concentrations are presented as geometric mean concentrations, expressed in international units/milliliter (IU/mL).
Time frame: Two months after dose 3
Population: The analysis was performed on the According to Protocol cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Rotarix Group | Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies | Anti-tetanus | 1.457 International Units / milliliter |
| Rotarix Group | Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies | Anti-diphtheria | 0.283 International Units / milliliter |
| Placebo Group | Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies | Anti-tetanus | 1.035 International Units / milliliter |
| Placebo Group | Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies | Anti-diphtheria | 0.219 International Units / milliliter |
Secondary
Geometric Mean Concentration for Anti-HBs Antibodies
Anti-HBs antibody concentrations are presented as geometric mean concentrations, expressed in milli international units/milliliter (mIU/mL).
Time frame: Two months after dose 3
Population: The analysis was performed on the According to Protocol cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Rotarix Group | Geometric Mean Concentration for Anti-HBs Antibodies | 25.6 Milli International Units/milliliter |
| Placebo Group | Geometric Mean Concentration for Anti-HBs Antibodies | 18.9 Milli International Units/milliliter |
Secondary
Geometric Mean Concentration for Anti-PRP Antibodies
Anti-PRP antibody concentrations are presented as geometric mean concentrations, expressed in microgram/milliliter (μg/mL).
Time frame: Two months after dose 3
Population: The analysis was performed on the According to Protocol cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Rotarix Group | Geometric Mean Concentration for Anti-PRP Antibodies | 4.641 microgram/milliliter |
| Placebo Group | Geometric Mean Concentration for Anti-PRP Antibodies | 4.865 microgram/milliliter |
Secondary
Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.
Anti-polio types 1, 2 and 3 antibody titers are presented as geometric mean titers.
Time frame: Two months after dose 3
Population: The analysis was performed on the According To Protocol cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Rotarix Group | Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. | Anti-polio 1 | 90.5 Titer |
| Rotarix Group | Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. | Anti-polio 2 | 142.6 Titer |
| Rotarix Group | Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. | Anti-polio 3 | 44.7 Titer |
| Placebo Group | Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. | Anti-polio 1 | 53.0 Titer |
| Placebo Group | Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. | Anti-polio 2 | 252.4 Titer |
| Placebo Group | Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. | Anti-polio 3 | 66.0 Titer |
Secondary
Human Immunodeficiency Virus (HIV) Viral Load
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).
Time frame: At the screening visit and 2 months after dose 3
Population: Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotarix Group | Human Immunodeficiency Virus (HIV) Viral Load | At screening | 5.7 base-10 logarithm of copies/milliliter | Standard Deviation 0.52 |
| Rotarix Group | Human Immunodeficiency Virus (HIV) Viral Load | Two months after dose 3 | 5.6 base-10 logarithm of copies/milliliter | Standard Deviation 0.77 |
| Placebo Group | Human Immunodeficiency Virus (HIV) Viral Load | At screening | 5.7 base-10 logarithm of copies/milliliter | Standard Deviation 0.51 |
| Placebo Group | Human Immunodeficiency Virus (HIV) Viral Load | Two months after dose 3 | 5.7 base-10 logarithm of copies/milliliter | Standard Deviation 0.51 |
Secondary
Number of Subjects Reporting Any Serious Adverse Events
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.
Time frame: 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)
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Any Serious Adverse Events | 17 Participants |
| Placebo Group | Number of Subjects Reporting Any Serious Adverse Events | 12 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Symptoms
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.
Time frame: Within 30 days after any dose
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Any Unsolicited Symptoms | 47 Participants |
| Placebo Group | Number of Subjects Reporting Any Unsolicited Symptoms | 48 Participants |
Secondary
Number of Subjects Reporting Each Type of Solicited Symptom
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.
Time frame: Within the 15-day solicited follow-up period after each dose
Population: Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available and who had their symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Diarrhoea, after dose 1 | 8 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Cough, after dose 2 | 18 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Irritability, after dose 3 | 17 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Diarrhoea, after dose 2 | 3 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Fever, after dose 1 | 20 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Fever, after dose 2 | 15 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Vomiting, after dose 3 | 12 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Irritability, after dose 2 | 20 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Irritability, after dose 1 | 24 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Loss of appetite, after dose 2 | 15 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Cough, after dose 1 | 24 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Vomiting, after dose 2 | 9 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Loss of appetite, after dose 1 | 18 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Cough, after dose 3 | 18 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Loss of appetite, after dose 3 | 10 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Diarrhoea, after dose 3 | 7 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Vomiting, after dose 1 | 11 Participants |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited Symptom | Fever, after dose 3 | 17 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Vomiting, after dose 1 | 10 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Fever, after dose 3 | 13 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Irritability, after dose 3 | 18 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Loss of appetite, after dose 3 | 12 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Cough, after dose 1 | 25 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Diarrhoea, after dose 1 | 8 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Fever, after dose 1 | 19 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Irritability, after dose 1 | 24 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Loss of appetite, after dose 1 | 19 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Vomiting, after dose 3 | 6 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Cough, after dose 2 | 19 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Diarrhoea, after dose 2 | 7 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Fever, after dose 2 | 12 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Irritability, after dose 2 | 19 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Loss of appetite, after dose 2 | 15 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Vomiting, after dose 2 | 10 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Cough, after dose 3 | 17 Participants |
| Placebo Group | Number of Subjects Reporting Each Type of Solicited Symptom | Diarrhoea, after dose 3 | 4 Participants |
Secondary
Number of Subjects Who Seroconverted Against Rotavirus
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.
Time frame: Two months after dose 3
Population: Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Who Seroconverted Against Rotavirus | 12 Participants |
| Placebo Group | Number of Subjects Who Seroconverted Against Rotavirus | 4 Participants |
Secondary
Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value
The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter (EL.U/mL).
Time frame: Two months after dose 3
Population: The analysis was performed on the According To Protocol cohort for immunogenicity.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value | 19 Participants |
| Placebo Group | Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value | 14 Participants |
Secondary
Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value
The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL).
Time frame: Two months after dose 3
Population: The analysis was performed on the According To Protocol cohort for immunogenicity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotarix Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value | Anti-diphtheria | 19 Participants |
| Rotarix Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value | Anti-tetanus | 23 Participants |
| Placebo Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value | Anti-tetanus | 24 Participants |
| Placebo Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value | Anti-diphtheria | 19 Participants |
Secondary
Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value
The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).
Time frame: Two months after dose 3
Population: The analysis was performed on the According To Protocol cohort for immunogenicity.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value | 15 Participants |
| Placebo Group | Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value | 11 Participants |
Secondary
Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value
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.
Time frame: Two months after dose 3
Population: The analysis was performed on the According To Protocol cohort for immunogenicity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotarix Group | Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value | Anti-polio type 1 | 19 Participants |
| Rotarix Group | Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value | Anti-polio type 2 | 23 Participants |
| Rotarix Group | Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value | Anti-polio type 3 | 18 Participants |
| Placebo Group | Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value | Anti-polio type 1 | 15 Participants |
| Placebo Group | Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value | Anti-polio type 2 | 21 Participants |
| Placebo Group | Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value | Anti-polio type 3 | 15 Participants |
Secondary
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value
Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL).
Time frame: Two months after dose 3
Population: The analysis was performed on the According To Protocol Cohort for immunogenicity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotarix Group | Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value | ≥ 0.15 µg/mL | 20 Participants |
| Rotarix Group | Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value | ≥ 1 µg/mL | 20 Participants |
| Placebo Group | Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value | ≥ 0.15 µg/mL | 23 Participants |
| Placebo Group | Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value | ≥ 1 µg/mL | 22 Participants |
Secondary
Number of Subjects With the RV in Stool Samples
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 \[NA\]).
Time frame: From Dose 1 until post Dose 3
Population: Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 7; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 21; Yes) | 1 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 7; NA) | 1 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 7; Yes ) | 7 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 14; Yes) | 2 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 14; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 14; NA) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 42; Yes) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 21; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 42; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 14; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 42; NA) | 1 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 21; NA) | 4 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Post Dose 3 (Day 0; Yes) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Post Dose 3 (Day 0; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Post Dose 3 (Day 0; NA) | 1 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Overall total (overall total; Yes) | 10 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 7; NA) | 2 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Overall total (overall total; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 14; Mixed) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Overall total (overall total; Mixed type) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 7; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Overall total (overall total; NA) | 16 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 14; NA) | 4 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 14; Yes) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 14; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 14; NA) | 1 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 21; Yes) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 21; No) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 21; NA) | 2 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 7; Yes) | 0 Participants |
| Rotarix Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 14; Yes) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 7; No) | 1 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 7; Yes ) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 7; No) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 7; NA) | 1 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 14; Yes) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 14; No) | 1 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 14; Mixed) | 1 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 14; NA) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 21; Yes) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 21; No) | 1 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 1 (Day 21; NA) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 7; Yes) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 7; No) | 1 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 2 (Day 7; NA) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 7; Yes) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Overall total (overall total; NA) | 2 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 7; NA) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 42; Yes) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 42; No) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Dose 3 (Day 42; NA) | 1 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Overall total (overall total; Yes) | 0 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Overall total (overall total; No) | 4 Participants |
| Placebo Group | Number of Subjects With the RV in Stool Samples | Overall total (overall total; Mixed type) | 1 Participants |
Secondary
Number of Subjects With Vaccine Take
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.
Time frame: Two months after dose 3
Population: Analysis was performed on subjects from the According To Protocol Cohort for immunogenicity for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects With Vaccine Take | 15 Participants |
| Placebo Group | Number of Subjects With Vaccine Take | 7 Participants |
Secondary
Rotavirus Antigen Excretion in Stool Samples
Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end.
Time frame: 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
Population: The analysis was performed on the According to Protocol Cohort for immunogenicity.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Rotavirus Antigen Excretion in Stool Samples | 11 Participants |
| Placebo Group | Rotavirus Antigen Excretion in Stool Samples | 5 Participants |
Secondary
Rotavirus in Diarrheal Stool Samples
Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode.
Time frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding
Population: Analysis was performed on the Total Vaccinated Cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Rotavirus in Diarrheal Stool Samples | 4 Participants |
| Placebo Group | Rotavirus in Diarrheal Stool Samples | 4 Participants |
Secondary
Rotavirus Vaccine Strain Identification
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.
Time frame: From dose 1 until 2 months after dose 3 or until end of RV shedding
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotarix Group | Rotavirus Vaccine Strain Identification | G2+P4 | 0 Number of episodes |
| Rotarix Group | Rotavirus Vaccine Strain Identification | GX+P6 | 1 Number of episodes |
| Rotarix Group | Rotavirus Vaccine Strain Identification | G3+P8 | 0 Number of episodes |
| Rotarix Group | Rotavirus Vaccine Strain Identification | Unknown | 1 Number of episodes |
| Rotarix Group | Rotavirus Vaccine Strain Identification | G1WT+P8WT | 2 Number of episodes |
| Placebo Group | Rotavirus Vaccine Strain Identification | Unknown | 2 Number of episodes |
| Placebo Group | Rotavirus Vaccine Strain Identification | G1WT+P8WT | 0 Number of episodes |
| Placebo Group | Rotavirus Vaccine Strain Identification | G2+P4 | 1 Number of episodes |
| Placebo Group | Rotavirus Vaccine Strain Identification | G3+P8 | 1 Number of episodes |
| Placebo Group | Rotavirus Vaccine Strain Identification | GX+P6 | 0 Number of episodes |
Secondary
Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations
Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.
Time frame: Two months after dose 3
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Rotarix Group | Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations | 75.5 Units/milliliter |
Secondary
The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent
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.
Time frame: At the screening visit and 2 months after dose 3 (Visit 4)
Population: Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotarix Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | No suppression at screening | 37 Participants |
| Rotarix Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Moderate suppression at Visit 4 | 15 Participants |
| Rotarix Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Moderate suppression at screening | 12 Participants |
| Rotarix Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | No suppression at Visit 4 | 13 Participants |
| Rotarix Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Severe suppression at Visit 4 | 11 Participants |
| Rotarix Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Unknown at Visit 4 | 4 Participants |
| Rotarix Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Severe suppression at screening | 1 Participants |
| Placebo Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Unknown at Visit 4 | 4 Participants |
| Placebo Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Severe suppression at screening | 2 Participants |
| Placebo Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Moderate suppression at screening | 15 Participants |
| Placebo Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | No suppression at screening | 33 Participants |
| Placebo Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Severe suppression at Visit 4 | 7 Participants |
| Placebo Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | Moderate suppression at Visit 4 | 18 Participants |
| Placebo Group | The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent | No suppression at Visit 4 | 10 Participants |