Trial Outcomes & Findings for Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC (NCT NCT00322335)
NCT ID: NCT00322335
Last Updated: 2016-10-20
Results Overview
The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
230 participants
Primary outcome timeframe
18, 30, 42, 54 and 66 months after booster dose (day 0)
Results posted on
2016-10-20
Participant Flow
The follow-up timepoints include all subjects who came back for that timepoint. Therefore the amount of subjects who completed the previous timepoint does not correspond with the amount of subjects starting the following time-point per se.
Participant milestones
| Measure |
Menitorix/Pediarix Group
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Subjects 18 Months After Booster Dose
STARTED
|
58
|
123
|
3
|
|
Subjects 18 Months After Booster Dose
COMPLETED
|
58
|
123
|
3
|
|
Subjects 18 Months After Booster Dose
NOT COMPLETED
|
0
|
0
|
0
|
|
Subjects 30 Months After Booster Dose
STARTED
|
54
|
119
|
57
|
|
Subjects 30 Months After Booster Dose
COMPLETED
|
54
|
119
|
57
|
|
Subjects 30 Months After Booster Dose
NOT COMPLETED
|
0
|
0
|
0
|
|
Subjects 42 Months After Booster Dose
STARTED
|
51
|
113
|
56
|
|
Subjects 42 Months After Booster Dose
COMPLETED
|
51
|
113
|
56
|
|
Subjects 42 Months After Booster Dose
NOT COMPLETED
|
0
|
0
|
0
|
|
Subjects 54 Months After Booster Dose
STARTED
|
50
|
108
|
56
|
|
Subjects 54 Months After Booster Dose
COMPLETED
|
50
|
108
|
56
|
|
Subjects 54 Months After Booster Dose
NOT COMPLETED
|
0
|
0
|
0
|
|
Subjects 66 Months After Booster Dose
STARTED
|
48
|
104
|
53
|
|
Subjects 66 Months After Booster Dose
COMPLETED
|
48
|
104
|
53
|
|
Subjects 66 Months After Booster Dose
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
Baseline characteristics by cohort
| Measure |
Menitorix/Pediarix Group
n=58 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=123 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=57 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.3 Months
STANDARD_DEVIATION 0.54 • n=5 Participants
|
31.4 Months
STANDARD_DEVIATION 0.64 • n=7 Participants
|
31.5 Months
STANDARD_DEVIATION 0.87 • n=5 Participants
|
31.4 Months
STANDARD_DEVIATION 0.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=50 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=110 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=52 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
Month 42 (N= 50; 110; 52)
|
39 subjects
|
106 subjects
|
33 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
Month 54 (N= 49; 106; 51)
|
38 subjects
|
103 subjects
|
33 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
Month 66 (N= 46; 101; 46)
|
38 subjects
|
95 subjects
|
28 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
Month 18 (N= 45; 96; 0)
|
44 subjects
|
93 subjects
|
0 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
Month 30 (N= 48; 101; 45)
|
39 subjects
|
96 subjects
|
31 subjects
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
The cut-off value for the rSBA-MenC titers was equal to or above 1:32. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=50 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=110 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=52 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
Month 54 (N= 49; 106; 51)
|
37 subjects
|
100 subjects
|
29 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
Month 66 (N= 46; 101; 46)
|
37 subjects
|
88 subjects
|
25 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
Month 18 (N= 45; 96; 0)
|
40 subjects
|
93 subjects
|
0 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
Month 30 (N= 48; 101; 45)
|
36 subjects
|
94 subjects
|
25 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
Month 42 (N= 50; 110; 52)
|
38 subjects
|
100 subjects
|
30 subjects
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
The cut-off value for the rSBA-MenC titers was equal to or above 1:128. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=50 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=110 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=52 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
Month 18 (N= 45; 96; 0)
|
27 subjects
|
82 subjects
|
0 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
Month 42 (N= 50; 110; 52)
|
30 subjects
|
89 subjects
|
13 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
Month 54 (N= 49; 106; 51)
|
27 subjects
|
86 subjects
|
15 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
Month 66 (N= 46; 101; 46)
|
28 subjects
|
69 subjects
|
18 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
Month 30 (N= 48; 101; 45)
|
27 subjects
|
80 subjects
|
12 subjects
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
Titers are expressed as Geometric Mean Titers (GMTs). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=50 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=110 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=52 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
rSBA-MenC Titers
Month 18 (N= 45; 96; 0)
|
221.5 titer
Interval 137.2 to 357.7
|
801.1 titer
Interval 570.3 to 1125.3
|
0 titer
Interval 0.0 to 0.0
|
|
rSBA-MenC Titers
Month 30 (N= 48; 101; 45)
|
109.1 titer
Interval 61.9 to 192.3
|
441.7 titer
Interval 309.4 to 630.6
|
40.3 titer
Interval 21.9 to 74.1
|
|
rSBA-MenC Titers
Month 42 (N= 50; 110; 52)
|
98.9 titer
Interval 56.7 to 172.5
|
409.8 titer
Interval 297.7 to 564.2
|
36.1 titer
Interval 20.4 to 63.8
|
|
rSBA-MenC Titers
Month 54 (N= 49; 106; 51)
|
90.4 titer
Interval 52.8 to 154.8
|
344.6 titer
Interval 255.9 to 463.9
|
36.7 titer
Interval 21.1 to 64.0
|
|
rSBA-MenC Titers
Month 66 (N= 46; 101; 46)
|
121.5 titer
Interval 71.0 to 207.9
|
227.6 titer
Interval 160.2 to 323.3
|
42.7 titer
Interval 22.3 to 81.8
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=56 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=122 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=53 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
Month 18 (N= 56; 122; 3)
|
56 subjects
|
121 subjects
|
3 subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
Month 30 (N= 53; 113; 53)
|
53 subjects
|
112 subjects
|
53 subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
Month 42 (N= 50; 110; 51)
|
50 subjects
|
109 subjects
|
51 subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
Month 54 (N= 49; 106; 52)
|
49 subjects
|
105 subjects
|
52 subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
Month 66 (N= 47; 101; 47)
|
47 subjects
|
101 subjects
|
46 subjects
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=56 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=122 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=53 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
Month 18 (N= 56; 122; 3)
|
44 subjects
|
112 subjects
|
3 subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
Month 30 (N= 53; 113; 53)
|
36 subjects
|
98 subjects
|
40 subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
Month 42 (N= 50; 110; 51)
|
33 subjects
|
91 subjects
|
34 subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
Month 54 (N= 49; 106; 52)
|
27 subjects
|
86 subjects
|
35 subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
Month 66 (N= 47; 101; 47)
|
26 subjects
|
84 subjects
|
26 subjects
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=56 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=122 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=53 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Anti-PRP Concentrations
Month 18 (N= 56; 122; 3)
|
2.921 µg/mL (microgram per milliliter)
Interval 2.15 to 3.968
|
5.450 µg/mL (microgram per milliliter)
Interval 4.39 to 6.766
|
2.547 µg/mL (microgram per milliliter)
Interval 0.39 to 16.651
|
|
Anti-PRP Concentrations
Month 30 (N= 53; 113; 53)
|
1.914 µg/mL (microgram per milliliter)
Interval 1.383 to 2.648
|
3.524 µg/mL (microgram per milliliter)
Interval 2.813 to 4.415
|
2.224 µg/mL (microgram per milliliter)
Interval 1.578 to 3.133
|
|
Anti-PRP Concentrations
Month 42 (N= 50; 110; 51)
|
1.735 µg/mL (microgram per milliliter)
Interval 1.243 to 2.423
|
2.986 µg/mL (microgram per milliliter)
Interval 2.395 to 3.722
|
2.005 µg/mL (microgram per milliliter)
Interval 1.365 to 2.946
|
|
Anti-PRP Concentrations
Month 54 (N= 49; 106; 52)
|
1.552 µg/mL (microgram per milliliter)
Interval 1.154 to 2.087
|
2.688 µg/mL (microgram per milliliter)
Interval 2.149 to 3.361
|
1.799 µg/mL (microgram per milliliter)
Interval 1.267 to 2.555
|
|
Anti-PRP Concentrations
Month 66 (N= 47; 101; 47)
|
1.602 µg/mL (microgram per milliliter)
Interval 1.107 to 2.32
|
2.625 µg/mL (microgram per milliliter)
Interval 2.113 to 3.261
|
1.763 µg/mL (microgram per milliliter)
Interval 1.17 to 2.657
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=56 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=122 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=53 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
Month 18 (N= 56; 122; 0)
|
38 subjects
|
100 subjects
|
0 subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
Month 30 (N= 52; 108; 53)
|
19 subjects
|
58 subjects
|
19 subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
Month 42 (N= 49; 107; 52)
|
17 subjects
|
52 subjects
|
17 subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
Month 54 (N= 46; 105; 52)
|
14 subjects
|
52 subjects
|
17 subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
Month 66 (45; 99; 45)
|
12 subjects
|
34 subjects
|
11 subjects
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=56 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=122 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=53 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
Month 18 (N= 56; 122; 0)
|
1 subjects
|
31 subjects
|
0 subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
Month 30 (N= 52; 108; 53)
|
1 subjects
|
18 subjects
|
3 subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
Month 66 (N= 45; 99; 45)
|
0 subjects
|
8 subjects
|
0 subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
Month 42 (N= 49; 107; 52)
|
0 subjects
|
14 subjects
|
2 subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
Month 54 (N= 46; 105; 52)
|
1 subjects
|
10 subjects
|
1 subjects
|
PRIMARY outcome
Timeframe: 18, 30, 42, 54 and 66 months after the booster dose (day 0)Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
Concentrations for anti-PSC antibody were expressed as GMCs.
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=56 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=122 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=53 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Anti-PSC Concentrations
Month 18 (N= 56; 122; 0)
|
0.50 µg/mL (microgram per milliliter)
Interval 0.39 to 0.64
|
1.01 µg/mL (microgram per milliliter)
Interval 0.8 to 1.29
|
0 µg/mL (microgram per milliliter)
Interval 0.0 to 0.0
|
|
Anti-PSC Concentrations
Month 42 (N= 49; 107; 52)
|
0.25 µg/mL (microgram per milliliter)
Interval 0.2 to 0.31
|
0.40 µg/mL (microgram per milliliter)
Interval 0.32 to 0.51
|
0.28 µg/mL (microgram per milliliter)
Interval 0.21 to 0.37
|
|
Anti-PSC Concentrations
Month 54 (N= 46; 105; 52)
|
0.24 µg/mL (microgram per milliliter)
Interval 0.19 to 0.3
|
0.36 µg/mL (microgram per milliliter)
Interval 0.29 to 0.45
|
0.26 µg/mL (microgram per milliliter)
Interval 0.2 to 0.32
|
|
Anti-PSC Concentrations
Month 66 (N= 45; 99; 45)
|
0.22 µg/mL (microgram per milliliter)
Interval 0.18 to 0.27
|
0.29 µg/mL (microgram per milliliter)
Interval 0.23 to 0.36
|
0.22 µg/mL (microgram per milliliter)
Interval 0.18 to 0.28
|
|
Anti-PSC Concentrations
Month 30 (N= 52; 108; 53)
|
0.26 µg/mL (microgram per milliliter)
Interval 0.21 to 0.33
|
0.47 µg/mL (microgram per milliliter)
Interval 0.37 to 0.61
|
0.30 µg/mL (microgram per milliliter)
Interval 0.23 to 0.39
|
PRIMARY outcome
Timeframe: From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)Population: Analysis was performed on the Total Cohort, which included all vaccinated subjects in the booster study (NC00323050) and who came back during the follow-up.
Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Menitorix/Pediarix Group
n=58 Participants
Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
n=123 Participants
Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
|
Infanrix Hexa/Meningitec Group
n=57 Participants
Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
0 subjects
|
0 subjects
|
0 subjects
|
Adverse Events
Menitorix/Pediarix Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Infanrix Hexa/Meningitec Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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