Trial Outcomes & Findings for Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB (NCT NCT00359983)
NCT ID: NCT00359983
Last Updated: 2016-12-16
Results Overview
Results up to 5 years after the fourth dose are presented.
COMPLETED
PHASE3
270 participants
One year, three years, and five years after the fourth dose vaccination.
2016-12-16
Participant Flow
Participant milestones
| Measure |
MenHibrix 4-dose Group
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
Year 1 Persistence Follow-up
STARTED
|
138
|
70
|
62
|
|
Year 1 Persistence Follow-up
COMPLETED
|
138
|
70
|
62
|
|
Year 1 Persistence Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 3 Persistence Follow-up
STARTED
|
103
|
47
|
51
|
|
Year 3 Persistence Follow-up
COMPLETED
|
103
|
47
|
51
|
|
Year 3 Persistence Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 5 Persistence Follow-up
STARTED
|
95
|
44
|
42
|
|
Year 5 Persistence Follow-up
COMPLETED
|
95
|
44
|
42
|
|
Year 5 Persistence Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
Baseline characteristics by cohort
| Measure |
MenHibrix 4-dose Group
n=138 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=70 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=62 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Months
|
27.4 Months
STANDARD_DEVIATION 3.37 • n=5 Participants
|
28.2 Months
STANDARD_DEVIATION 4.05 • n=7 Participants
|
28.4 Months
STANDARD_DEVIATION 3.69 • n=5 Participants
|
27.8 Months
STANDARD_DEVIATION 3.64 • n=4 Participants
|
|
Gender
Female
|
67 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Gender
Male
|
71 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=116 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=51 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=46 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Year 1 (N=116; 51; 46)
|
116 Subjects
|
49 Subjects
|
46 Subjects
|
|
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Year 3 (N=61; 28; 36)
|
60 Subjects
|
26 Subjects
|
36 Subjects
|
|
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Year 5 (N=84; 39; 37)
|
83 Subjects
|
36 Subjects
|
36 Subjects
|
PRIMARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=116 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=52 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=48 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Year 1 (N=116; 52; 48)
|
112 Subjects
|
12 Subjects
|
34 Subjects
|
|
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Year 3 (N=59; 27; 35)
|
48 Subjects
|
3 Subjects
|
20 Subjects
|
|
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Year 5 (N=76; 38; 34)
|
63 Subjects
|
8 Subjects
|
25 Subjects
|
PRIMARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=105 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=50 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=47 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Year 1 (N=105; 50; 47)
|
88 Subjects
|
0 Subjects
|
31 Subjects
|
|
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Year 3 (N=58; 26; 34)
|
39 Subjects
|
4 Subjects
|
19 Subjects
|
|
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Year 5 (N=82; 38; 35)
|
57 Subjects
|
7 Subjects
|
19 Subjects
|
SECONDARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL). Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=116 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=51 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=46 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
Anti-PRP Geometric Mean Concentrations (GMCs)
Year 5 (N=84; 39; 37)
|
1.248 µg/mL
Interval 0.97 to 1.605
|
0.803 µg/mL
Interval 0.524 to 1.231
|
0.689 µg/mL
Interval 0.447 to 1.064
|
|
Anti-PRP Geometric Mean Concentrations (GMCs)
Year 1 (N=116; 51; 46)
|
2.400 µg/mL
Interval 1.937 to 2.975
|
1.943 µg/mL
Interval 1.308 to 2.887
|
1.162 µg/mL
Interval 0.808 to 1.672
|
|
Anti-PRP Geometric Mean Concentrations (GMCs)
Year 3 (N=61; 28; 36)
|
1.169 µg/mL
Interval 0.851 to 1.605
|
1.031 µg/mL
Interval 0.625 to 1.7
|
0.898 µg/mL
Interval 0.623 to 1.293
|
SECONDARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=116 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=51 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=46 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
Year 1 (N= 116; 51; 46)
|
88 Subjects
|
35 Subjects
|
24 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
Year 3 (N=61; 28; 36)
|
33 Subjects
|
14 Subjects
|
14 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
Year 5 (N= 84; 39; 37)
|
47 Subjects
|
17 Subjects
|
10 Subjects
|
SECONDARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition. Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=116 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=52 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=48 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
hSBA-MenC Geometric Mean Titers (GMTs)
Year 5 (N= 76; 38; 34)
|
69.8 Titer
Interval 41.8 to 116.5
|
3.6 Titer
Interval 2.4 to 5.4
|
44.2 Titer
Interval 18.8 to 103.9
|
|
hSBA-MenC Geometric Mean Titers (GMTs)
Year 1 (N= 116; 52; 48)
|
150.1 Titer
Interval 116.5 to 193.4
|
3.9 Titer
Interval 2.7 to 5.5
|
26.3 Titer
Interval 14.8 to 46.5
|
|
hSBA-MenC Geometric Mean Titers (GMTs)
Year 3 (N= 59; 27; 35)
|
41.9 Titer
Interval 25.8 to 68.0
|
2.7 Titer
Interval 1.9 to 3.7
|
16.0 Titer
Interval 7.4 to 34.9
|
SECONDARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=116 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=52 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=48 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
Year 1 (N= 116; 52; 48)
|
112 Subjects
|
12 Subjects
|
34 Subjects
|
|
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
Year 3 (N= 59; 27; 35)
|
48 Subjects
|
3 Subjects
|
20 Subjects
|
|
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
Year 5 (N= 76; 38; 34)
|
63 Subjects
|
8 Subjects
|
26 Subjects
|
SECONDARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition. Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=105 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=50 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=47 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
hSBA-MenY Geometric Mean Titers (GMTs)
Year 1 (N= 105; 50; 47)
|
128.8 Titer
Interval 86.2 to 192.5
|
2.0 Titer
Interval 2.0 to 2.0
|
41.1 Titer
Interval 20.4 to 82.9
|
|
hSBA-MenY Geometric Mean Titers (GMTs)
Year 3 (N= 58; 26; 34)
|
29.9 Titer
Interval 16.9 to 52.8
|
3.5 Titer
Interval 2.0 to 6.3
|
16.6 Titer
Interval 8.0 to 34.4
|
|
hSBA-MenY Geometric Mean Titers (GMTs)
Year 5 (N= 82; 38; 35)
|
26.8 Titer
Interval 17.7 to 40.4
|
3.6 Titer
Interval 2.4 to 5.5
|
17.8 Titer
Interval 8.4 to 37.7
|
SECONDARY outcome
Timeframe: One year, three years, and five years after the fourth dose vaccination.Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
Results up to 5 years after the fourth dose are presented.
Outcome measures
| Measure |
MenHibrix 4-dose Group
n=105 Participants
Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 4-dose Group
n=50 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
ActHIB 3-dose + MenHibrix 4th-dose Group
n=47 Participants
Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
|
|---|---|---|---|
|
Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4
Year 1 (N= 105; 50; 47)
|
89 Subjects
|
0 Subjects
|
31 Subjects
|
|
Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4
Year 3 (N= 58; 26; 34)
|
39 Subjects
|
4 Subjects
|
19 Subjects
|
|
Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4
Year 5 (N= 82; 38; 35)
|
57 Subjects
|
7 Subjects
|
19 Subjects
|
Adverse Events
MenHibrix 4-dose Group
ActHIB 4-dose Group
ActHIB 3-dose + MenHibrix 4th-dose Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
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