Trial Outcomes & Findings for Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib (NCT NCT00473668)
NCT ID: NCT00473668
Last Updated: 2017-08-18
Results Overview
A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
At Month 3
Results posted on
2017-08-18
Participant Flow
Out of 300 subjects enrolled in the study, one did not receive any vaccination.
Participant milestones
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
99
|
|
Overall Study
COMPLETED
|
95
|
89
|
89
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
10
|
Reasons for withdrawal
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
|
Overall Study
Migrated/moved from study area
|
3
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
6
|
|
Overall Study
Other
|
2
|
3
|
4
|
Baseline Characteristics
Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
Baseline characteristics by cohort
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=100 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=100 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=99 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
6.3 weeks
STANDARD_DEVIATION 0.59 • n=5 Participants
|
6.4 weeks
STANDARD_DEVIATION 0.64 • n=7 Participants
|
6.3 weeks
STANDARD_DEVIATION 0.51 • n=5 Participants
|
6.3 weeks
STANDARD_DEVIATION 0.58 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
|
93 Participants
|
84 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=92 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
|
92 Subjects
|
85 Subjects
|
89 Subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen
Anti-D
|
93 Subjects
|
85 Subjects
|
88 Subjects
|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen
Anti-T
|
93 Subjects
|
85 Subjects
|
89 Subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off
|
93 Subjects
|
85 Subjects
|
89 Subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available
Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
|
88 Subjects
|
80 Subjects
|
89 Subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen
|
92 Subjects
|
85 Subjects
|
88 Subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen
|
91 Subjects
|
84 Subjects
|
88 Subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens
|
26.709 μg/mL
Interval 19.161 to 37.232
|
19.583 μg/mL
Interval 14.019 to 27.356
|
40.748 μg/mL
Interval 32.301 to 51.404
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens
Anti-D
|
2.894 IU/mL
Interval 2.3 to 3.64
|
1.654 IU/mL
Interval 1.357 to 2.016
|
1.756 IU/mL
Interval 1.406 to 2.193
|
|
Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens
Anti-T
|
4.740 IU/mL
Interval 3.777 to 5.95
|
2.772 IU/mL
Interval 2.235 to 3.438
|
2.825 IU/mL
Interval 2.316 to 3.447
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=92 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)
|
781.1 mIU/mL
Interval 629.7 to 968.8
|
695.3 mIU/mL
Interval 542.1 to 891.7
|
598.2 mIU/mL
Interval 477.7 to 749.1
|
SECONDARY outcome
Timeframe: At Month 3Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=93 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=85 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=89 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen
|
63.4 EL.U/mL
Interval 55.4 to 72.7
|
100.3 EL.U/mL
Interval 88.4 to 113.7
|
83.7 EL.U/mL
Interval 73.6 to 95.2
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period post-vaccinationPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=97 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=96 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=95 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
74 Subjects
|
69 Subjects
|
68 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
28 Subjects
|
28 Subjects
|
17 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
55 Subjects
|
58 Subjects
|
42 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
5 Subjects
|
10 Subjects
|
4 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
63 Subjects
|
59 Subjects
|
51 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
16 Subjects
|
16 Subjects
|
17 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
76 Subjects
|
64 Subjects
|
65 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
29 Subjects
|
24 Subjects
|
14 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
54 Subjects
|
45 Subjects
|
42 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
4 Subjects
|
6 Subjects
|
4 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
60 Subjects
|
53 Subjects
|
48 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
20 Subjects
|
23 Subjects
|
15 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
69 Subjects
|
61 Subjects
|
53 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
23 Subjects
|
15 Subjects
|
10 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
53 Subjects
|
50 Subjects
|
41 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
6 Subjects
|
5 Subjects
|
6 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
60 Subjects
|
50 Subjects
|
40 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
16 Subjects
|
11 Subjects
|
11 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
87 Subjects
|
84 Subjects
|
81 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
46 Subjects
|
39 Subjects
|
26 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
73 Subjects
|
74 Subjects
|
68 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
13 Subjects
|
16 Subjects
|
10 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
80 Subjects
|
76 Subjects
|
68 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
32 Subjects
|
30 Subjects
|
30 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period post-vaccinationPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade. Grade 3 Irritability= crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness/Loss of appetite= Drowsiness/Loss of appetite that prevented normal activity. Grade 3 fever = fever above (\>) 39.5°C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=96 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=96 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=95 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1
|
42 Subjects
|
37 Subjects
|
29 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1
|
35 Subjects
|
31 Subjects
|
24 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1
|
61 Subjects
|
51 Subjects
|
33 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1
|
49 Subjects
|
42 Subjects
|
26 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1
|
62 Subjects
|
47 Subjects
|
46 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1
|
8 Subjects
|
7 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1
|
49 Subjects
|
38 Subjects
|
36 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1
|
34 Subjects
|
28 Subjects
|
20 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1
|
2 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1
|
31 Subjects
|
24 Subjects
|
15 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2
|
52 Subjects
|
41 Subjects
|
27 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
7 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2
|
46 Subjects
|
37 Subjects
|
26 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2
|
45 Subjects
|
47 Subjects
|
31 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2
|
39 Subjects
|
40 Subjects
|
28 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2
|
57 Subjects
|
49 Subjects
|
41 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2
|
9 Subjects
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2
|
52 Subjects
|
46 Subjects
|
38 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2
|
36 Subjects
|
30 Subjects
|
19 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2
|
3 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2
|
33 Subjects
|
29 Subjects
|
18 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 3
|
45 Subjects
|
35 Subjects
|
24 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 3
|
6 Subjects
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 3
|
44 Subjects
|
35 Subjects
|
24 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 3
|
42 Subjects
|
31 Subjects
|
29 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 3
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 3
|
41 Subjects
|
31 Subjects
|
29 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 3
|
42 Subjects
|
45 Subjects
|
33 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 3
|
7 Subjects
|
6 Subjects
|
4 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 3
|
41 Subjects
|
45 Subjects
|
33 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 3
|
23 Subjects
|
27 Subjects
|
25 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 3
|
2 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 3
|
23 Subjects
|
27 Subjects
|
25 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across doses
|
64 Subjects
|
58 Subjects
|
46 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across doses
|
10 Subjects
|
8 Subjects
|
4 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across doses
|
61 Subjects
|
55 Subjects
|
42 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Across doses
|
77 Subjects
|
73 Subjects
|
57 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Across doses
|
0 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Across doses
|
73 Subjects
|
68 Subjects
|
54 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across doses
|
75 Subjects
|
69 Subjects
|
61 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across doses
|
17 Subjects
|
14 Subjects
|
8 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across doses
|
72 Subjects
|
66 Subjects
|
58 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across doses
|
55 Subjects
|
45 Subjects
|
40 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across doses
|
4 Subjects
|
5 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across doses
|
52 Subjects
|
43 Subjects
|
36 Subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0-30) follow-up period post-vaccinationPopulation: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
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.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=100 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=99 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=100 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
6 Subjects
|
4 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0-Month 3)Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
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.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=100 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=100 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=99 Participants
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
Adverse Events
Tritanrix-HepB/Hiberix Kft. Group
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Tritanrix-HepB/Hiberix LD Group
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
Tritanrix-HepB/Hiberix HD Group
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tritanrix-HepB/Hiberix Kft. Group
n=100 participants at risk
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix LD Group
n=100 participants at risk
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
Tritanrix-HepB/Hiberix HD Group
n=99 participants at risk
Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
|
|---|---|---|---|
|
General disorders
Pain
|
89.7%
87/97 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
87.5%
84/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
85.3%
81/95 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
|
General disorders
Redness (mm)
|
75.3%
73/97 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
77.1%
74/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
71.6%
68/95 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
|
General disorders
Swelling (mm)
|
82.5%
80/97 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
79.2%
76/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
71.6%
68/95 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
|
General disorders
Drowsiness
|
66.7%
64/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
60.4%
58/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
48.4%
46/95 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
|
General disorders
Fever (Axillary)
|
80.2%
77/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
76.0%
73/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
60.0%
57/95 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
|
General disorders
Irritability
|
78.1%
75/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
71.9%
69/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
64.2%
61/95 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
|
General disorders
Loss of appetite
|
57.3%
55/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
46.9%
45/96 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
42.1%
40/95 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3); Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30); SAEs: during the entire study period (Day 0 - Month 3).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER