Hepatitis B
Conditions
Keywords
Diphtheria, Pertussis, Prophylaxis, Hepatitis B diseases, Tetanus
Brief summary
To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
Detailed description
Randomized study with five groups to receive one of the following vaccination regimens: One of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the two formulations of GSK Biologicals' DTPw-HBV + Placebo CSL's DTPw + GSK Biologicals' HBV
Interventions
BIOLOGICALTritanrix™-HepB
GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
BIOLOGICALRotarix™
GSK Biologicals' live attenuated human rotavirus vaccine
BIOLOGICALZilbrix™
GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
BIOLOGICALTriple Antigen™
Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
BIOLOGICALEngerix™-B
GSK Biologicals' hepatitis B vaccine
DRUGPlacebo
Placebo for the Rotarix™ vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 4 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol. * Administration of one dose of hepatitis B vaccine at birth. * A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (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. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required) * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies | At one month post dose 3 [PIII(M4)] | Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies | At one most post dose 3 [PIII(M4)] | A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL). |
| Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values | At one month post dose 3 [PIII(M4)] | A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). |
| Number of Subjects With Vaccine Response to BPT Antigen | At one month post dose 3 [PIII(M4)] | Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination. |
| Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values | At 2.5 months after dose 2 of Rotarix [PIII(M4)] | A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL). |
| Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen | At one month post dose 3 [PIII(M4)] | A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL). |
| Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | At one month post dose 3 [PIII(M4)] | A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8 |
| Concentrations of Anti-HBs Antibodies | At one month post dose 3 [PIII(M4)] | Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL. |
| Anti-Polio Type 1, 2, 3 Antibody Titers | At one month post dose 3 [PIII(M4)] | Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs). |
| Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA | At one month post dose 3 [PIII(M4)] | A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL. |
| Concentrations of Anti-DT Antibodies | At one month post dose 3 [PIII(M4)] | Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL. |
| Concentrations of Anti-T Antibodies | At one month post dose 3 [PIII(M4)] | Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL). |
| Concentrations of Anti-BPT Antibodies | At one month post dose 3 [PIII(M4)] | Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL. |
| Concentrations of Anti-RV Antibodies | At 2.5 months post dose 2 of Rotarix [PIII(M4)] | Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL. |
| Number of Subjects With Any Solicited General Symptoms | During the 8-day period (Days 0-7) post-vaccination | Assessed solicited general symptoms were diarrhea, drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability, loss of appetite \[loss of appet.\] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) follow-up period | Number of subjects with any unsolicited adverse events (AEs) An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 to Month 4 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Solicited Local Symptoms | During the 8-Day (Days 0-7) follow-up period | Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm). |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tritanrix-HepB+Rotarix Group Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age. | 80 |
| Tritanrix-HepB+Placebo Group Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age. | 25 |
| Zilbrix+Rotarix Group Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age. | 81 |
| Zilbrix+Placebo Group Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age. | 23 |
| Triple Antigen+Engerix-B Group Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively. | 99 |
| Total | 308 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Serious adverse event | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 | 6 | 1 | 3 |
Baseline characteristics
| Characteristic | Tritanrix-HepB+Rotarix Group | Tritanrix-HepB+Placebo Group | Zilbrix+Rotarix Group | Zilbrix+Placebo Group | Triple Antigen+Engerix-B Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 13.0 Weeks STANDARD_DEVIATION 1.7 | 13.4 Weeks STANDARD_DEVIATION 1.87 | 12.8 Weeks STANDARD_DEVIATION 1.39 | 12.8 Weeks STANDARD_DEVIATION 1.56 | 12.9 Weeks STANDARD_DEVIATION 1.33 | 12.93 Weeks STANDARD_DEVIATION 1.51 |
| Sex: Female, Male Female | 42 Participants | 6 Participants | 45 Participants | 11 Participants | 48 Participants | 152 Participants |
| Sex: Female, Male Male | 38 Participants | 19 Participants | 36 Participants | 12 Participants | 51 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 74 / 80 | 25 / 25 | 74 / 81 | 22 / 23 | 96 / 99 |
| serious Total, serious adverse events | 1 / 80 | 0 / 25 | 7 / 81 | 0 / 23 | 2 / 99 |
Outcome results
Primary
Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies
Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis were performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies | 100 IU/mL |
| Tritanrix-HepB+Placebo Group | Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies | 100 IU/mL |
| Zilbrix+Rotarix Group | Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies | 100 IU/mL |
| Zilbrix+Placebo Group | Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies | 100 IU/mL |
| Triple Antigen+Engerix-B Group | Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies | 98.9 IU/mL |
Secondary
Anti-Polio Type 1, 2, 3 Antibody Titers
Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tritanrix-HepB+Rotarix Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 1, [N=54,17,47,14,72] | 900.7 Titers |
| Tritanrix-HepB+Rotarix Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 3, [N=57,18,55,15,79] | 326.6 Titers |
| Tritanrix-HepB+Rotarix Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 2, [N=58,18,57,14,79] | 811.2 Titers |
| Tritanrix-HepB+Placebo Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 2, [N=58,18,57,14,79] | 1024.0 Titers |
| Tritanrix-HepB+Placebo Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 1, [N=54,17,47,14,72] | 1181.0 Titers |
| Tritanrix-HepB+Placebo Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 3, [N=57,18,55,15,79] | 369.1 Titers |
| Zilbrix+Rotarix Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 2, [N=58,18,57,14,79] | 774.2 Titers |
| Zilbrix+Rotarix Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 1, [N=54,17,47,14,72] | 877.7 Titers |
| Zilbrix+Rotarix Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 3, [N=57,18,55,15,79] | 313.3 Titers |
| Zilbrix+Placebo Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 1, [N=54,17,47,14,72] | 779.9 Titers |
| Zilbrix+Placebo Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 3, [N=57,18,55,15,79] | 330.3 Titers |
| Zilbrix+Placebo Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 2, [N=58,18,57,14,79] | 882.6 Titers |
| Triple Antigen+Engerix-B Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 2, [N=58,18,57,14,79] | 825.9 Titers |
| Triple Antigen+Engerix-B Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 1, [N=54,17,47,14,72] | 1155.0 Titers |
| Triple Antigen+Engerix-B Group | Anti-Polio Type 1, 2, 3 Antibody Titers | Anti-Polio 3, [N=57,18,55,15,79] | 351.3 Titers |
Secondary
Concentrations of Anti-BPT Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Concentrations of Anti-BPT Antibodies | 65.7 EL.U/mL |
| Tritanrix-HepB+Placebo Group | Concentrations of Anti-BPT Antibodies | 50.8 EL.U/mL |
| Zilbrix+Rotarix Group | Concentrations of Anti-BPT Antibodies | 40.1 EL.U/mL |
| Zilbrix+Placebo Group | Concentrations of Anti-BPT Antibodies | 37.2 EL.U/mL |
| Triple Antigen+Engerix-B Group | Concentrations of Anti-BPT Antibodies | 38.0 EL.U/mL |
Secondary
Concentrations of Anti-DT Antibodies
Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Concentrations of Anti-DT Antibodies | 0.667 IU/mL |
| Tritanrix-HepB+Placebo Group | Concentrations of Anti-DT Antibodies | 0.545 IU/mL |
| Zilbrix+Rotarix Group | Concentrations of Anti-DT Antibodies | 0.957 IU/mL |
| Zilbrix+Placebo Group | Concentrations of Anti-DT Antibodies | 0.906 IU/mL |
| Triple Antigen+Engerix-B Group | Concentrations of Anti-DT Antibodies | 1.096 IU/mL |
Secondary
Concentrations of Anti-HBs Antibodies
Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Concentrations of Anti-HBs Antibodies | 600.5 mIU/mL |
| Tritanrix-HepB+Placebo Group | Concentrations of Anti-HBs Antibodies | 732.7 mIU/mL |
| Zilbrix+Rotarix Group | Concentrations of Anti-HBs Antibodies | 789.8 mIU/mL |
| Zilbrix+Placebo Group | Concentrations of Anti-HBs Antibodies | 850.6 mIU/mL |
| Triple Antigen+Engerix-B Group | Concentrations of Anti-HBs Antibodies | 578.6 mIU/mL |
Secondary
Concentrations of Anti-RV Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.
Time frame: At 2.5 months post dose 2 of Rotarix [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.lysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Concentrations of Anti-RV Antibodies | 96.4 U/mL |
| Tritanrix-HepB+Placebo Group | Concentrations of Anti-RV Antibodies | 10.0 U/mL |
| Zilbrix+Rotarix Group | Concentrations of Anti-RV Antibodies | 93.1 U/mL |
| Zilbrix+Placebo Group | Concentrations of Anti-RV Antibodies | 10.0 U/mL |
Secondary
Concentrations of Anti-T Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Concentrations of Anti-T Antibodies | 3.138 IU/mL |
| Tritanrix-HepB+Placebo Group | Concentrations of Anti-T Antibodies | 3.350 IU/mL |
| Zilbrix+Rotarix Group | Concentrations of Anti-T Antibodies | 3.737 IU/mL |
| Zilbrix+Placebo Group | Concentrations of Anti-T Antibodies | 5.323 IU/mL |
| Triple Antigen+Engerix-B Group | Concentrations of Anti-T Antibodies | 3.319 IU/mL |
Secondary
Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values
A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values | 67 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values | 19 Subjects |
| Zilbrix+Rotarix Group | Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values | 60 Subjects |
| Zilbrix+Placebo Group | Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values | 16 Subjects |
| Triple Antigen+Engerix-B Group | Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values | 79 Subjects |
Secondary
Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values
A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).
Time frame: At 2.5 months after dose 2 of Rotarix [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values | 42 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values | 41 Subjects |
| Zilbrix+Placebo Group | Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values | 0 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA
A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA | 65 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA | 17 Subjects |
| Zilbrix+Rotarix Group | Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA | 60 Subjects |
| Zilbrix+Placebo Group | Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA | 17 Subjects |
| Triple Antigen+Engerix-B Group | Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA | 85 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies
A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).
Time frame: At one most post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies | 64 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies | 19 Subjects |
| Zilbrix+Rotarix Group | Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies | 58 Subjects |
| Zilbrix+Placebo Group | Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies | 16 Subjects |
| Triple Antigen+Engerix-B Group | Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies | 84 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)
A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 1, [N=54,17,47,14,72] | 54 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 3, [N=57,18,55,15,79] | 56 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 2, [N=58,18,57,14,79] | 58 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 2, [N=58,18,57,14,79] | 18 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 1, [N=54,17,47,14,72] | 17 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 3, [N=57,18,55,15,79] | 17 Subjects |
| Zilbrix+Rotarix Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 2, [N=58,18,57,14,79] | 57 Subjects |
| Zilbrix+Rotarix Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 1, [N=54,17,47,14,72] | 47 Subjects |
| Zilbrix+Rotarix Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 3, [N=57,18,55,15,79] | 55 Subjects |
| Zilbrix+Placebo Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 1, [N=54,17,47,14,72] | 14 Subjects |
| Zilbrix+Placebo Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 3, [N=57,18,55,15,79] | 15 Subjects |
| Zilbrix+Placebo Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 2, [N=58,18,57,14,79] | 14 Subjects |
| Triple Antigen+Engerix-B Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 2, [N=58,18,57,14,79] | 79 Subjects |
| Triple Antigen+Engerix-B Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 1, [N=54,17,47,14,72] | 72 Subjects |
| Triple Antigen+Engerix-B Group | Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) | Anti-Polio 3, [N=57,18,55,15,79] | 79 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen
A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen | 68 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen | 20 Subjects |
| Zilbrix+Rotarix Group | Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen | 62 Subjects |
| Zilbrix+Placebo Group | Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen | 17 Subjects |
| Triple Antigen+Engerix-B Group | Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen | 87 Subjects |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were diarrhea, drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability, loss of appetite \[loss of appet.\] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.
Time frame: During the 8-day period (Days 0-7) post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Across[N=78;25;77;23;98] | 53 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 3[N=76;25;73;22;96] | 20 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 1[N=78;25;77;23;98] | 49 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 1[N=78;25;77;23;98] | 28 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 1[N=78;25;77;23;98] | 43 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Across[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 3[N=76;25;73;22;96] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Across[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 1[N=78;25;77;23;98] | 9 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 2[N=76;25;75;22;96] | 28 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 2[N=76;25;75;22;96] | 22 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 1[N=78;25;77;23;98] | 4 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 2[N=76;25;75;22;96] | 37 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Across[N=78;25;77;23;98] | 50 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Across[N=78;25;77;23;98] | 43 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 1[N=78;25;77;23;98] | 4 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 1[N=78;25;77;23;98] | 6 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 3[N=76;25;73;22;96] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 3[N=76;25;73;22;96] | 35 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 2[N=76;25;75;22;96] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 2[N=76;25;75;22;96] | 3 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Across[N=78;25;77;23;98] | 8 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 1[N=78;25;77;23;98] | 42 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Across[N=78;25;77;23;98] | 4 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Across[N=78;25;77;23;98] | 12 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Across[N=78;25;77;23;98] | 7 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Across[N=78;25;77;23;98] | 59 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Across[N=78;25;77;23;98] | 39 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Across[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1[N=78;25;77;23;98] | 50 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 3[N=76;25;73;22;96] | 18 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2[N=76;25;75;22;96] | 29 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3[N=76;25;73;22;96] | 25 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 1[N=78;25;77;23;98] | 6 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 1[N=78;25;77;23;98] | 35 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 2[N=76;25;75;22;96] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3[N=76;25;73;22;96] | 38 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1[N=78;25;77;23;98] | 54 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Across[N=78;25;77;23;98] | 8 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 2[N=76;25;75;22;96] | 26 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 3[N=76;25;73;22;96] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 3[N=76;25;73;22;96] | 3 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Across[N=78;25;77;23;98] | 54 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 3[N=76;25;73;22;96] | 3 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 2[N=76;25;75;22;96] | 22 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Across[N=78;25;77;23;98] | 3 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 3[N=76;25;73;22;96] | 22 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Across[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across[N=78;25;77;23;98] | 61 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 2[N=76;25;75;22;96] | 20 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across[N=78;25;77;23;98] | 58 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 1[N=78;25;77;23;98] | 42 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 3[N=76;25;73;22;96] | 22 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2[N=76;25;75;22;96] | 41 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 3[N=76;25;73;22;96] | 24 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Across[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Across[N=78;25;77;23;98] | 18 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 2[N=76;25;75;22;96] | 9 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 3[N=76;25;73;22;96] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Across[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 2[N=76;25;75;22;96] | 9 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Across[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 1[N=78;25;77;23;98] | 9 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 2[N=76;25;75;22;96] | 9 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 1[N=78;25;77;23;98] | 12 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Across[N=78;25;77;23;98] | 20 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Across[N=78;25;77;23;98] | 13 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Across[N=78;25;77;23;98] | 13 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 3[N=76;25;73;22;96] | 8 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 1[N=78;25;77;23;98] | 13 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 1[N=78;25;77;23;98] | 17 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3[N=76;25;73;22;96] | 13 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 1[N=78;25;77;23;98] | 9 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Across[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 3[N=76;25;73;22;96] | 13 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 3[N=76;25;73;22;96] | 7 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 3[N=76;25;73;22;96] | 7 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Across[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 1[N=78;25;77;23;98] | 5 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 3[N=76;25;73;22;96] | 8 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Across[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 3[N=76;25;73;22;96] | 2 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Across[N=78;25;77;23;98] | 14 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Across[N=78;25;77;23;98] | 2 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Across[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across[N=78;25;77;23;98] | 19 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Across[N=78;25;77;23;98] | 20 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2[N=76;25;75;22;96] | 9 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 3[N=76;25;73;22;96] | 5 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1[N=78;25;77;23;98] | 16 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Across[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 2[N=76;25;75;22;96] | 7 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3[N=76;25;73;22;96] | 15 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 2[N=76;25;75;22;96] | 10 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 3[N=76;25;73;22;96] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across[N=78;25;77;23;98] | 23 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1[N=78;25;77;23;98] | 23 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 2[N=76;25;75;22;96] | 9 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Across[N=78;25;77;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2[N=76;25;75;22;96] | 10 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 3[N=76;25;73;22;96] | 27 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 3[N=76;25;73;22;96] | 1 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 1[N=78;25;77;23;98] | 5 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 3[N=76;25;73;22;96] | 27 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Across[N=78;25;77;23;98] | 5 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3[N=76;25;73;22;96] | 40 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 3[N=76;25;73;22;96] | 37 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 1[N=78;25;77;23;98] | 49 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Across[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 3[N=76;25;73;22;96] | 15 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 3[N=76;25;73;22;96] | 2 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 3[N=76;25;73;22;96] | 13 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Across[N=78;25;77;23;98] | 6 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 3[N=76;25;73;22;96] | 2 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 3[N=76;25;73;22;96] | 2 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1[N=78;25;77;23;98] | 56 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Across[N=78;25;77;23;98] | 10 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Across[N=78;25;77;23;98] | 34 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 1[N=78;25;77;23;98] | 4 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 1[N=78;25;77;23;98] | 52 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 1[N=78;25;77;23;98] | 34 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Across[N=78;25;77;23;98] | 2 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 2[N=76;25;75;22;96] | 1 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 1[N=78;25;77;23;98] | 27 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 1[N=78;25;77;23;98] | 7 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 1[N=78;25;77;23;98] | 5 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 1[N=78;25;77;23;98] | 4 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Across[N=78;25;77;23;98] | 64 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 2[N=76;25;75;22;96] | 3 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Across[N=78;25;77;23;98] | 7 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2[N=76;25;75;22;96] | 32 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1[N=78;25;77;23;98] | 52 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 2[N=76;25;75;22;96] | 31 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across[N=78;25;77;23;98] | 66 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 2[N=76;25;75;22;96] | 31 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Across[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 2[N=76;25;75;22;96] | 1 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 2[N=76;25;75;22;96] | 30 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2[N=76;25;75;22;96] | 49 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Across[N=78;25;77;23;98] | 59 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Across[N=78;25;77;23;98] | 39 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 2[N=76;25;75;22;96] | 44 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 2[N=76;25;75;22;96] | 12 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Across[N=78;25;77;23;98] | 3 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 2[N=76;25;75;22;96] | 12 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 1[N=78;25;77;23;98] | 49 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Across[N=78;25;77;23;98] | 59 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 2[N=76;25;75;22;96] | 4 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Across[N=78;25;77;23;98] | 52 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 2[N=76;25;75;22;96] | 3 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 1[N=78;25;77;23;98] | 49 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Across[N=78;25;77;23;98] | 2 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3[N=76;25;73;22;96] | 26 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Across[N=78;25;77;23;98] | 12 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 3[N=76;25;73;22;96] | 1 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 3[N=76;25;73;22;96] | 24 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across[N=78;25;77;23;98] | 54 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Across[N=78;25;77;23;98] | 15 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1[N=78;25;77;23;98] | 15 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 1[N=78;25;77;23;98] | 13 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 1[N=78;25;77;23;98] | 12 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 1[N=78;25;77;23;98] | 11 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1[N=78;25;77;23;98] | 17 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 1[N=78;25;77;23;98] | 2 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 1[N=78;25;77;23;98] | 13 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 1[N=78;25;77;23;98] | 11 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 1[N=78;25;77;23;98] | 10 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2[N=76;25;75;22;96] | 11 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 2[N=76;25;75;22;96] | 9 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 2[N=76;25;75;22;96] | 11 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 2[N=76;25;75;22;96] | 10 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2[N=76;25;75;22;96] | 11 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 2[N=76;25;75;22;96] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 2[N=76;25;75;22;96] | 9 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 2[N=76;25;75;22;96] | 5 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 2[N=76;25;75;22;96] | 4 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3[N=76;25;73;22;96] | 13 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 3[N=76;25;73;22;96] | 11 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 3[N=76;25;73;22;96] | 11 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 3[N=76;25;73;22;96] | 10 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3[N=76;25;73;22;96] | 13 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 3[N=76;25;73;22;96] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 3[N=76;25;73;22;96] | 12 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 3[N=76;25;73;22;96] | 6 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 3[N=76;25;73;22;96] | 6 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Across[N=78;25;77;23;98] | 3 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Across[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Across[N=78;25;77;23;98] | 2 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across[N=78;25;77;23;98] | 19 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Across[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Across[N=78;25;77;23;98] | 18 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Across[N=78;25;77;23;98] | 17 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Across[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across[N=78;25;77;23;98] | 20 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Across[N=78;25;77;23;98] | 3 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Across[N=78;25;77;23;98] | 19 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Across[N=78;25;77;23;98] | 14 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Across[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Across[N=78;25;77;23;98] | 12 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Across[N=78;25;77;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Across[N=78;25;77;23;98] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Across[N=78;25;77;23;98] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 3[N=76;25;73;22;96] | 41 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 3[N=76;25;73;22;96] | 33 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 1[N=78;25;77;23;98] | 2 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across[N=78;25;77;23;98] | 68 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3[N=76;25;73;22;96] | 36 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 1[N=78;25;77;23;98] | 68 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Across[N=78;25;77;23;98] | 6 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 2[N=76;25;75;22;96] | 6 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Across[N=78;25;77;23;98] | 62 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 2[N=76;25;75;22;96] | 8 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 2[N=76;25;75;22;96] | 22 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Across[N=78;25;77;23;98] | 20 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Across[N=78;25;77;23;98] | 80 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 2[N=76;25;75;22;96] | 23 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 1[N=78;25;77;23;98] | 48 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Across[N=78;25;77;23;98] | 4 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 2[N=76;25;75;22;96] | 55 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 2[N=76;25;75;22;96] | 3 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2[N=76;25;75;22;96] | 61 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 2[N=76;25;75;22;96] | 44 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Across[N=78;25;77;23;98] | 78 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 2[N=76;25;75;22;96] | 1 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 2[N=76;25;75;22;96] | 45 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Drowsiness, Dose 2[N=76;25;75;22;96] | 35 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 1[N=78;25;77;23;98] | 6 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across[N=78;25;77;23;98] | 84 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Drowsiness, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2[N=76;25;75;22;96] | 41 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 2[N=76;25;75;22;96] | 2 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1[N=78;25;77;23;98] | 56 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Across[N=78;25;77;23;98] | 12 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 2[N=76;25;75;22;96] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Dose 2[N=76;25;75;22;96] | 3 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 1[N=78;25;77;23;98] | 8 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Across[N=78;25;77;23;98] | 14 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Across[N=78;25;77;23;98] | 80 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 1[N=78;25;77;23;98] | 11 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Across[N=78;25;77;23;98] | 3 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Across[N=78;25;77;23;98] | 48 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 1[N=78;25;77;23;98] | 27 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 1[N=78;25;77;23;98] | 32 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Dose 1[N=78;25;77;23;98] | 1 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Across[N=78;25;77;23;98] | 3 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 1[N=78;25;77;23;98] | 65 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 1[N=78;25;77;23;98] | 10 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Vomiting, Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1[N=78;25;77;23;98] | 70 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Vomiting, Dose 3[N=76;25;73;22;96] | 5 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Vomiting, Dose 3[N=76;25;73;22;96] | 7 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Dose 3[N=76;25;73;22;96] | 16 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Dose 1[N=78;25;77;23;98] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Diarrhea, Across[N=78;25;77;23;98] | 4 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Loss of appet., Dose 3[N=76;25;73;22;96] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appet., Dose 3[N=76;25;73;22;96] | 17 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Irritability, Dose 3[N=76;25;73;22;96] | 51 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Loss of appet., Across[N=78;25;77;23;98] | 45 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Diarrhea, Across[N=78;25;77;23;98] | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Irritability, Dose 3[N=76;25;73;22;96] | 2 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3[N=76;25;73;22;96] | 53 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 3[N=76;25;73;22;96] | 41 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Fever, Dose 1[N=78;25;77;23;98] | 67 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Related Diarrhea, Across[N=78;25;77;23;98] | 3 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Any Solicited General Symptoms | Grade 3 Fever, Dose 3[N=76;25;73;22;96] | 1 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 to Month 4
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Serious Adverse Events (SAEs) | 7 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).
Time frame: During the 8-Day (Days 0-7) follow-up period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 [N=78;25;76;23;98] | 27 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=78;25;76;23;98] | 9 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=76;25;75;22;96] | 48 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=76;25;75;22;96] | 3 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=76;25;75;22;96] | 31 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 [N=78;25;76;23;98] | 7 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=78;25;76;23;98] | 60 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=78;25;76;23;98] | 9 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=78;25;76;23;98] | 51 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 [N=78;25;76;23;98] | 6 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=78;25;76;23;98] | 44 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 3 [N=76;25;75;22;96] | 2 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 3 [N=76;25;75;22;96] | 33 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 3 [N=76;25;75;22;96] | 2 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 [N=78;25;76;23;98] | 49 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=78;25;76;23;98] | 10 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 3 [N=76;25;75;22;96] | 48 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 3 [N=76;25;75;22;96] | 3 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 3 [N=76;25;75;22;96] | 35 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 [N=78;25;76;23;98] | 8 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 [N=78;25;76;23;98] | 40 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=76;25;75;22;96] | 1 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=76;25;75;22;96] | 32 Subjects |
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=76;25;75;22;96] | 3 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 [N=78;25;76;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 [N=78;25;76;23;98] | 13 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 [N=78;25;76;23;98] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 [N=78;25;76;23;98] | 15 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 [N=78;25;76;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 [N=78;25;76;23;98] | 9 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=76;25;75;22;96] | 11 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=76;25;75;22;96] | 16 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=76;25;75;22;96] | 0 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=76;25;75;22;96] | 8 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=76;25;75;22;96] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 3 [N=76;25;75;22;96] | 8 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 3 [N=76;25;75;22;96] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 3 [N=76;25;75;22;96] | 16 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 3 [N=76;25;75;22;96] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 3 [N=76;25;75;22;96] | 10 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 3 [N=76;25;75;22;96] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=78;25;76;23;98] | 17 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=78;25;76;23;98] | 1 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=78;25;76;23;98] | 20 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=78;25;76;23;98] | 2 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=78;25;76;23;98] | 16 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=78;25;76;23;98] | 2 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=78;25;76;23;98] | 58 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 [N=78;25;76;23;98] | 54 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=76;25;75;22;96] | 36 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 3 [N=76;25;75;22;96] | 53 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=76;25;75;22;96] | 3 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=78;25;76;23;98] | 52 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 3 [N=76;25;75;22;96] | 4 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 3 [N=76;25;75;22;96] | 3 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=76;25;75;22;96] | 36 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 [N=78;25;76;23;98] | 8 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 [N=78;25;76;23;98] | 6 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 [N=78;25;76;23;98] | 46 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 3 [N=76;25;75;22;96] | 38 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=76;25;75;22;96] | 3 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=76;25;75;22;96] | 58 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 [N=78;25;76;23;98] | 4 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 3 [N=76;25;75;22;96] | 5 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=78;25;76;23;98] | 8 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 3 [N=76;25;75;22;96] | 34 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=78;25;76;23;98] | 65 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=78;25;76;23;98] | 11 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=76;25;75;22;96] | 3 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=78;25;76;23;98] | 11 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 [N=78;25;76;23;98] | 33 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=76;25;75;22;96] | 7 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=78;25;76;23;98] | 20 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 [N=78;25;76;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 3 [N=76;25;75;22;96] | 10 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 [N=78;25;76;23;98] | 17 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 3 [N=76;25;75;22;96] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=78;25;76;23;98] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 3 [N=76;25;75;22;96] | 15 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 3 [N=76;25;75;22;96] | 0 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 [N=78;25;76;23;98] | 4 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=78;25;76;23;98] | 12 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 3 [N=76;25;75;22;96] | 9 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=78;25;76;23;98] | 4 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 3 [N=76;25;75;22;96] | 2 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=78;25;76;23;98] | 18 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 [N=78;25;76;23;98] | 14 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=78;25;76;23;98] | 6 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 [N=78;25;76;23;98] | 3 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=76;25;75;22;96] | 11 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 [N=78;25;76;23;98] | 7 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=76;25;75;22;96] | 1 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=76;25;75;22;96] | 15 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=78;25;76;23;98] | 62 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=76;25;75;22;96] | 61 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 3 [N=76;25;75;22;96] | 57 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 3 [N=76;25;75;22;96] | 41 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 [N=78;25;76;23;98] | 8 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=78;25;76;23;98] | 22 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 [N=78;25;76;23;98] | 61 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=76;25;75;22;96] | 6 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=76;25;75;22;96] | 8 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 [N=78;25;76;23;98] | 8 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 [N=78;25;76;23;98] | 31 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=78;25;76;23;98] | 57 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=76;25;75;22;96] | 37 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=78;25;76;23;98] | 77 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 3 [N=76;25;75;22;96] | 47 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 3 [N=76;25;75;22;96] | 11 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=76;25;75;22;96] | 43 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=78;25;76;23;98] | 18 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=76;25;75;22;96] | 4 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 3 [N=76;25;75;22;96] | 4 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 [N=78;25;76;23;98] | 51 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 [N=78;25;76;23;98] | 13 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 3 [N=76;25;75;22;96] | 5 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=78;25;76;23;98] | 16 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
Number of subjects with any unsolicited adverse events (AEs) An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Days 0-30) follow-up period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 8 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 6 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 19 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 5 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 12 Subjects |
Secondary
Number of Subjects With Vaccine Response to BPT Antigen
Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.
Time frame: At one month post dose 3 [PIII(M4)]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB+Rotarix Group | Number of Subjects With Vaccine Response to BPT Antigen | 67 Subjects |
| Tritanrix-HepB+Placebo Group | Number of Subjects With Vaccine Response to BPT Antigen | 19 Subjects |
| Zilbrix+Rotarix Group | Number of Subjects With Vaccine Response to BPT Antigen | 60 Subjects |
| Zilbrix+Placebo Group | Number of Subjects With Vaccine Response to BPT Antigen | 16 Subjects |
| Triple Antigen+Engerix-B Group | Number of Subjects With Vaccine Response to BPT Antigen | 79 Subjects |