Trial Outcomes & Findings for A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa (NCT NCT00263666)

NCT ID: NCT00263666

Last Updated: 2020-11-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: Within the 15-day solicited follow-up period after any dose
• Results posted on: 2020-11-23

Participant Flow

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.

Participant milestones

Measure	Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Overall Study STARTED	50	50
Overall Study COMPLETED	43	39
Overall Study NOT COMPLETED	7	11

Reasons for withdrawal

Measure	Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Overall Study Adverse Event	6	8
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Total n=100 Participants Total of all reporting groups
Age, Continuous	7.1 weeks STANDARD_DEVIATION 1.10 • n=5 Participants	6.9 weeks STANDARD_DEVIATION 1.02 • n=7 Participants	7.0 weeks STANDARD_DEVIATION 1.06 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea	26 Participants	28 Participants

SECONDARY outcome

Timeframe: Within 30 days after any dose

Population: Analysis was performed on the Total Vaccinated Cohort.

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.

Outcome measures

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects Reporting Any Unsolicited Symptoms	47 Participants	48 Participants

SECONDARY outcome

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)

Population: 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.

Outcome measures

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects Reporting Any Serious Adverse Events	17 Participants	12 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects Reporting Each Type of Solicited Symptom Cough, after dose 1	24 Participants	25 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Diarrhoea, after dose 1	8 Participants	8 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Fever, after dose 1	20 Participants	19 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Irritability, after dose 1	24 Participants	24 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Loss of appetite, after dose 1	18 Participants	19 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Vomiting, after dose 1	11 Participants	10 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Cough, after dose 2	18 Participants	19 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Diarrhoea, after dose 2	3 Participants	7 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Fever, after dose 2	15 Participants	12 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Irritability, after dose 2	20 Participants	19 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Loss of appetite, after dose 2	15 Participants	15 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Vomiting, after dose 2	9 Participants	10 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Cough, after dose 3	18 Participants	17 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Diarrhoea, after dose 3	7 Participants	4 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Fever, after dose 3	17 Participants	13 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Irritability, after dose 3	17 Participants	18 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Loss of appetite, after dose 3	10 Participants	12 Participants
Number of Subjects Reporting Each Type of Solicited Symptom Vomiting, after dose 3	12 Participants	6 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
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	2 Participants
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	15 Participants
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	33 Participants
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	7 Participants
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	18 Participants
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	10 Participants
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	4 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Human Immunodeficiency Virus (HIV) Viral Load At screening	5.7 base-10 logarithm of copies/milliliter Standard Deviation 0.52	5.7 base-10 logarithm of copies/milliliter Standard Deviation 0.51
Human Immunodeficiency Virus (HIV) Viral Load Two months after dose 3	5.6 base-10 logarithm of copies/milliliter Standard Deviation 0.77	5.7 base-10 logarithm of copies/milliliter Standard Deviation 0.51

SECONDARY outcome

Timeframe: Two months after dose 3

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

Outcome measures

Measure	Rotarix Group n=21 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=22 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects Who Seroconverted Against Rotavirus	12 Participants	4 Participants

SECONDARY outcome

Timeframe: Two months after dose 3

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

Outcome measures

Measure	Rotarix Group n=23 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=22 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects With Vaccine Take	15 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Rotarix Group n=21 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations	75.5 Units/milliliter Interval 29.1 to 195.7	—

SECONDARY outcome

Timeframe: Two months after dose 3

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

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

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=24 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
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	23 Participants
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	22 Participants

SECONDARY outcome

Timeframe: Two months after dose 3

Population: 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).

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=24 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Geometric Mean Concentration for Anti-PRP Antibodies	4.641 microgram/milliliter Interval 1.764 to 12.215	4.865 microgram/milliliter Interval 2.322 to 10.192

SECONDARY outcome

Timeframe: Two months after dose 3

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

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

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=25 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
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	19 Participants
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	24 Participants

SECONDARY outcome

Timeframe: Two months after dose 3

Population: 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).

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=25 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies Anti-tetanus	1.457 International Units / milliliter Interval 0.794 to 2.674	1.035 International Units / milliliter Interval 0.647 to 1.656
Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies Anti-diphtheria	0.283 International Units / milliliter Interval 0.167 to 0.481	0.219 International Units / milliliter Interval 0.143 to 0.337

SECONDARY outcome

Timeframe: Two months after dose 3

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

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

Outcome measures

Measure	Rotarix Group n=23 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=20 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value	15 Participants	11 Participants

SECONDARY outcome

Timeframe: Two months after dose 3

Population: 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).

Outcome measures

Measure	Rotarix Group n=23 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=20 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Geometric Mean Concentration for Anti-HBs Antibodies	25.6 Milli International Units/milliliter Interval 14.3 to 45.8	18.9 Milli International Units/milliliter Interval 9.9 to 36.1

SECONDARY outcome

Timeframe: Two months after dose 3

Population: 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).

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=24 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value	19 Participants	14 Participants

SECONDARY outcome

Timeframe: Two months after dose 3

Population: 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).

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=24 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Geometric Mean Concentration for Anti-BPT Antibodies	28.8 ELISA-Units/milliliter Interval 19.3 to 42.8	18.1 ELISA-Units/milliliter Interval 12.8 to 25.6

SECONDARY outcome

Timeframe: Two months after dose 3

Population: 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.

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=24 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
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	21 Participants
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	15 Participants
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	15 Participants

SECONDARY outcome

Timeframe: Two months after dose 3

Population: 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.

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=24 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. Anti-polio 1	90.5 Titer Interval 36.4 to 225.3	53.0 Titer Interval 19.4 to 144.5
Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. Anti-polio 2	142.6 Titer Interval 60.8 to 334.2	252.4 Titer Interval 91.2 to 698.7
Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. Anti-polio 3	44.7 Titer Interval 19.2 to 104.2	66.0 Titer Interval 22.6 to 192.2

SECONDARY outcome

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

Population: 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.

Outcome measures

Measure	Rotarix Group n=25 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=25 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Rotavirus Antigen Excretion in Stool Samples	11 Participants	5 Participants

SECONDARY outcome

Timeframe: From Dose 1 until 2 months after dose 3 or until end of RV shedding

Population: Analysis was performed on the Total Vaccinated Cohort

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

Outcome measures

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Rotavirus in Diarrheal Stool Samples	4 Participants	4 Participants

SECONDARY outcome

Timeframe: From dose 1 until 2 months after dose 3 or until end of RV shedding

Population: 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.

Outcome measures

Measure	Rotarix Group n=50 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Rotavirus Vaccine Strain Identification G1WT+P8WT	2 Number of episodes	0 Number of episodes
Rotavirus Vaccine Strain Identification G2+P4	0 Number of episodes	1 Number of episodes
Rotavirus Vaccine Strain Identification G3+P8	0 Number of episodes	1 Number of episodes
Rotavirus Vaccine Strain Identification GX+P6	1 Number of episodes	0 Number of episodes
Rotavirus Vaccine Strain Identification Unknown	1 Number of episodes	2 Number of episodes

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Rotarix Group n=29 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=34 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Enteric Pathogens Identification Salmonella, positive	1 Participants	0 Participants
Enteric Pathogens Identification Campylobacter, negative	18 Participants	24 Participants
Enteric Pathogens Identification Campylobacter, positive	0 Participants	0 Participants
Enteric Pathogens Identification Campylobacter, unknown	11 Participants	10 Participants
Enteric Pathogens Identification E. histolytica, negative	18 Participants	24 Participants
Enteric Pathogens Identification E. histolytica, positive	0 Participants	0 Participants
Enteric Pathogens Identification E. histolytica, unknown	11 Participants	10 Participants
Enteric Pathogens Identification Salmonella, negative	17 Participants	24 Participants
Enteric Pathogens Identification Salmonella, unknown	11 Participants	10 Participants
Enteric Pathogens Identification Sto Epec, negative	3 Participants	5 Participants
Enteric Pathogens Identification Sto Epec, positive	0 Participants	0 Participants
Enteric Pathogens Identification Sto Epec, unknown	26 Participants	29 Participants
Enteric Pathogens Identification Sto G.Lamblia, negative	18 Participants	24 Participants
Enteric Pathogens Identification Sto G.Lamblia, positive	0 Participants	0 Participants
Enteric Pathogens Identification Sto G.Lamblia, unknown	11 Participants	10 Participants
Enteric Pathogens Identification Sto Shigella, negative	18 Participants	24 Participants
Enteric Pathogens Identification Sto Shigella, positive	0 Participants	0 Participants
Enteric Pathogens Identification Sto Shigella, unknown	11 Participants	10 Participants
Enteric Pathogens Identification Sto Yersinia, negative	18 Participants	24 Participants
Enteric Pathogens Identification Sto Yersinia, positive	0 Participants	0 Participants
Enteric Pathogens Identification Sto Yersinia, unknown	11 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.

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]).

Outcome measures

Measure	Rotarix Group n=26 Participants Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=7 Participants Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Number of Subjects With the RV in Stool Samples Overall total (overall total; Mixed type)	0 Participants	1 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 7; Yes )	7 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 7; No)	0 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 7; NA)	2 Participants	1 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 14; Yes)	0 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 14; No)	0 Participants	1 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 14; Mixed)	0 Participants	1 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 14; NA)	4 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 21; Yes)	1 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 21; No)	0 Participants	1 Participants
Number of Subjects With the RV in Stool Samples Dose 1 (Day 21; NA)	4 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 2 (Day 7; Yes)	—	0 Participants
Number of Subjects With the RV in Stool Samples Dose 2 (Day 7; No)	—	1 Participants
Number of Subjects With the RV in Stool Samples Dose 2 (Day 7; NA)	—	0 Participants
Number of Subjects With the RV in Stool Samples Dose 2 (Day 14; Yes)	0 Participants	—
Number of Subjects With the RV in Stool Samples Dose 2 (Day 14; No)	0 Participants	—
Number of Subjects With the RV in Stool Samples Dose 2 (Day 14; NA)	1 Participants	—
Number of Subjects With the RV in Stool Samples Dose 2 (Day 21; Yes)	0 Participants	—
Number of Subjects With the RV in Stool Samples Dose 2 (Day 21; No)	0 Participants	—
Number of Subjects With the RV in Stool Samples Dose 2 (Day 21; NA)	2 Participants	—
Number of Subjects With the RV in Stool Samples Dose 3 (Day 7; Yes)	0 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 3 (Day 7; No)	0 Participants	1 Participants
Number of Subjects With the RV in Stool Samples Dose 3 (Day 7; NA)	1 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 3 (Day 14; Yes)	2 Participants	—
Number of Subjects With the RV in Stool Samples Dose 3 (Day 14; No)	0 Participants	—
Number of Subjects With the RV in Stool Samples Dose 3 (Day 14; NA)	0 Participants	—
Number of Subjects With the RV in Stool Samples Dose 3 (Day 42; Yes)	0 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 3 (Day 42; No)	0 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Dose 3 (Day 42; NA)	1 Participants	1 Participants
Number of Subjects With the RV in Stool Samples Post Dose 3 (Day 0; Yes)	0 Participants	—
Number of Subjects With the RV in Stool Samples Post Dose 3 (Day 0; No)	0 Participants	—
Number of Subjects With the RV in Stool Samples Post Dose 3 (Day 0; NA)	1 Participants	—
Number of Subjects With the RV in Stool Samples Overall total (overall total; Yes)	10 Participants	0 Participants
Number of Subjects With the RV in Stool Samples Overall total (overall total; No)	0 Participants	4 Participants
Number of Subjects With the RV in Stool Samples Overall total (overall total; NA)	16 Participants	2 Participants

Adverse Events

Rotarix Group

Serious events: 17 serious events

Other events: 48 other events

Deaths: 6 deaths

Placebo Group

Serious events: 12 serious events

Other events: 47 other events

Deaths: 9 deaths

Serious adverse events

Measure	Rotarix Group n=50 participants at risk Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 participants at risk Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
Blood and lymphatic system disorders Anemia	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Eye disorders Conjunctivitis	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Gastrointestinal disorders Ileus paralytic	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
General disorders Sudden infant death syndrome	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Hepatobiliary disorders Jaundice	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Bronchiolitis	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Bronchopneumonia	14.0% 7/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Lobar pneumonia	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Pneumocystis jiroveci pneumonia	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Pneumonia	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Lymph node tuberculosis	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Pulmonary tuberculosis	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Tuberculosis	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Dysentery	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Gastroenteritis	12.0% 6/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations HIV infection	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Meningitis	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Oral candidiasis	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Otitis media	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Sepsis	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Metabolism and nutrition disorders Dehydration	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Metabolism and nutrition disorders Marasmus	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.

Other adverse events

Measure	Rotarix Group n=50 participants at risk Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.	Placebo Group n=50 participants at risk Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
General disorders Irritability	62.0% 31/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	56.0% 28/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
General disorders Loss of appetite	46.0% 23/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	46.0% 23/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Investigations Weight decreased	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
General disorders Cough	70.0% 35/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	62.0% 31/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
General disorders Diarrhoea	32.0% 16/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	32.0% 16/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
General disorders Fever	60.0% 30/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	56.0% 28/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Blood and lymphatic system disorders Lymphadenopathy	10.0% 5/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Blood and lymphatic system disorders Splenomegaly	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Gastrointestinal disorders Constipation	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Gastrointestinal disorders Vomiting	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	10.0% 5/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
General disorders Pyrexia	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	12.0% 6/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Upper respiratory tract infection	36.0% 18/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	28.0% 14/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Pulmonary tuberculosis	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Influenza	12.0% 6/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Pharyngitis	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	10.0% 5/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Skin and subcutaneous tissue disorders Dermatitis	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Skin and subcutaneous tissue disorders Dermatitis diaper	10.0% 5/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Skin and subcutaneous tissue disorders Eczema	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	16.0% 8/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Skin and subcutaneous tissue disorders Rash	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Gastrointestinal disorders Abdominal pain	4.0% 2/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
General disorders Vomiting	38.0% 19/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	30.0% 15/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Bronchopneumonia	22.0% 11/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	12.0% 6/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Gastroenteritis	18.0% 9/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	18.0% 9/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Oral candidiasis	30.0% 15/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	38.0% 19/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Otitis media	8.0% 4/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	12.0% 6/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Infections and infestations Sepsis	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Metabolism and nutrition disorders Dehydration	6.0% 3/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.	0.00% 0/50 • Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER