Trial Outcomes & Findings for Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose (NCT NCT01119625)
NCT ID: NCT01119625
Last Updated: 2018-09-20
Results Overview
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
238 participants
Primary outcome timeframe
Before booster vaccination at Month 0
Results posted on
2018-09-20
Participant Flow
This booster study was conducted in Singapore only wheras the primary vaccination phase (NCT00808444) was conducted in Singapore and Malaysia.
Participant milestones
| Measure |
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
120
|
|
Overall Study
COMPLETED
|
115
|
116
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
Baseline characteristics by cohort
| Measure |
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=118 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=120 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.8 Months
STANDARD_DEVIATION 0.84 • n=5 Participants
|
18.9 Months
STANDARD_DEVIATION 0.87 • n=7 Participants
|
18.9 Months
STANDARD_DEVIATION 0.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before booster vaccination at Month 0Population: The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=112 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=111 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-1 [Pre-booster]
|
0.35 µg/mL
Interval 0.3 to 0.41
|
0.48 µg/mL
Interval 0.4 to 0.57
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-4 [Pre-booster]
|
0.48 µg/mL
Interval 0.4 to 0.58
|
0.56 µg/mL
Interval 0.48 to 0.67
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-5 [Pre-booster]
|
0.54 µg/mL
Interval 0.47 to 0.63
|
0.76 µg/mL
Interval 0.65 to 0.89
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-6B [Pre-booster]
|
0.32 µg/mL
Interval 0.25 to 0.41
|
0.34 µg/mL
Interval 0.29 to 0.4
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-7F [Pre-booster]
|
0.91 µg/mL
Interval 0.78 to 1.07
|
0.88 µg/mL
Interval 0.75 to 1.03
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-9V [Pre-booster]
|
0.73 µg/mL
Interval 0.62 to 0.85
|
0.90 µg/mL
Interval 0.77 to 1.06
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-14 [Pre-booster]
|
0.91 µg/mL
Interval 0.75 to 1.11
|
1.06 µg/mL
Interval 0.86 to 1.31
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-18C [Pre-booster]
|
0.78 µg/mL
Interval 0.65 to 0.93
|
0.83 µg/mL
Interval 0.69 to 1.01
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-19F [Pre-booster]
|
0.96 µg/mL
Interval 0.82 to 1.13
|
1.10 µg/mL
Interval 0.87 to 1.4
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-23F [Pre-booster]
|
0.47 µg/mL
Interval 0.38 to 0.58
|
0.66 µg/mL
Interval 0.51 to 0.84
|
PRIMARY outcome
Timeframe: Before booster vaccination at Month 0Population: The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=118 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=116 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Protein D (PD).
|
619.7 EU/mL
Interval 530.1 to 724.3
|
801.6 EU/mL
Interval 693.1 to 927.1
|
SECONDARY outcome
Timeframe: Within 4 days (Days 0-3) after booster vaccination.Population: The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.
Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period. Solicited local symptoms assessed 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 above 30 millimetre (mm).
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=117 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=117 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Any swelling
|
49 Participants
|
45 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Any pain
|
70 Participants
|
61 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Grade 3 pain
|
13 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Any redness
|
61 Participants
|
66 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Grade 3 redness
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Grade 3 swelling
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 4 days (Days 0-3) after booster vaccination.Population: The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)). Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature \>39.5°C. Related = solicited symptom assessed by the investigator as causally related to study vaccination.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=117 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=117 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Grade 3 drowsiness
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Related drowsiness
|
48 Participants
|
38 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Fever >= 37.5°C
|
75 Participants
|
56 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Fever > 39.5°C
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Related fever
|
72 Participants
|
55 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Any irritability
|
67 Participants
|
51 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Grade 3 irritability
|
5 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Related irritability
|
67 Participants
|
50 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Grade 3 loss of appetite
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Any drowsiness
|
49 Participants
|
38 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Any loss of appetite
|
49 Participants
|
42 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Related loss of appetite
|
47 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Within 31 days (Days 0-30) after booster vaccinationPopulation: The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.
Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=120 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=118 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
|
25 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1Population: The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=120 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=118 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs).
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Opsonophagocytic activity (OPA) testing was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Opsonophagocytic activity (OPA) testing was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before booster vaccination at Month 0Population: The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=111 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=112 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Anti-6A [pre-booster]
|
0.21 µg/mL
Interval 0.16 to 0.26
|
0.23 µg/mL
Interval 0.18 to 0.28
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Anti-19A [pre-booster]
|
0.19 µg/mL
Interval 0.15 to 0.24
|
0.18 µg/mL
Interval 0.14 to 0.22
|
SECONDARY outcome
Timeframe: Before booster vaccination at Month 0Population: The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.
Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=49 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=43 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Diphtheria and Tetanus.
Anti-diphtheria [pre-booster]
|
0.30 IU/mL
Interval 0.24 to 0.39
|
0.32 IU/mL
Interval 0.25 to 0.39
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus.
Anti-tetanus [pre-booster]
|
0.47 IU/mL
Interval 0.38 to 0.59
|
0.51 IU/mL
Interval 0.43 to 0.61
|
SECONDARY outcome
Timeframe: Before booster vaccination at Month 0Population: The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.
Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=47 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=42 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-PT [pre-booster]
|
6.5 EU/mL
Interval 4.7 to 8.9
|
5.7 EU/mL
Interval 4.5 to 7.2
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-FHA [pre-booster]
|
29.2 EU/mL
Interval 21.5 to 39.6
|
19.5 EU/mL
Interval 15.1 to 25.3
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-PRN [pre-booster]
|
15.1 EU/mL
Interval 11.1 to 20.5
|
14.8 EU/mL
Interval 10.7 to 20.6
|
SECONDARY outcome
Timeframe: Before booster vaccination at Month 0Population: The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=57 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=52 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
|
0.85 µg/mL
Interval 0.65 to 1.11
|
0.68 µg/mL
Interval 0.5 to 0.92
|
SECONDARY outcome
Timeframe: Before booster vaccination at Month 0Population: The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.
Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=25 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=29 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 1 [pre-booster]
|
32.8 Titers
Interval 19.1 to 56.3
|
40.7 Titers
Interval 23.2 to 71.3
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 2 [pre-booster]
|
34.9 Titers
Interval 18.8 to 64.7
|
38.7 Titers
Interval 26.5 to 56.7
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 3 [pre-booster]
|
43.3 Titers
Interval 24.0 to 78.0
|
40.7 Titers
Interval 24.4 to 67.8
|
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Population: The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=111 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=109 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-23F [post-booster]
|
6.83 µg/mL
Interval 5.77 to 8.07
|
7.19 µg/mL
Interval 5.94 to 8.71
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-1 [pre-booster]
|
0.35 µg/mL
Interval 0.3 to 0.41
|
0.48 µg/mL
Interval 0.4 to 0.57
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-1 [post-booster]
|
6.29 µg/mL
Interval 5.38 to 7.35
|
7.14 µg/mL
Interval 6.12 to 8.32
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-4 [pre-booster]
|
0.48 µg/mL
Interval 0.4 to 0.58
|
0.56 µg/mL
Interval 0.47 to 0.67
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-4 [post-booster]
|
7.43 µg/mL
Interval 6.33 to 8.71
|
7.53 µg/mL
Interval 6.44 to 8.8
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-5 [pre-booster]
|
0.54 µg/mL
Interval 0.46 to 0.62
|
0.77 µg/mL
Interval 0.65 to 0.9
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-5 [post-booster]
|
7.16 µg/mL
Interval 6.25 to 8.2
|
7.91 µg/mL
Interval 6.91 to 9.06
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-6B [pre-booster]
|
0.32 µg/mL
Interval 0.25 to 0.41
|
0.34 µg/mL
Interval 0.29 to 0.4
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-6B [post-booster]
|
3.12 µg/mL
Interval 2.59 to 3.76
|
3.30 µg/mL
Interval 2.85 to 3.81
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-7F [pre-booster]
|
0.93 µg/mL
Interval 0.8 to 1.08
|
0.88 µg/mL
Interval 0.75 to 1.04
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-7F [post-booster]
|
9.25 µg/mL
Interval 8.04 to 10.64
|
9.02 µg/mL
Interval 7.77 to 10.47
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-9V [pre-booster]
|
0.72 µg/mL
Interval 0.62 to 0.84
|
0.90 µg/mL
Interval 0.77 to 1.06
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-9V [post-booster]
|
10.42 µg/mL
Interval 8.94 to 12.14
|
9.36 µg/mL
Interval 8.15 to 10.75
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-14 [pre-booster]
|
0.93 µg/mL
Interval 0.76 to 1.14
|
1.05 µg/mL
Interval 0.85 to 1.31
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-14 [post-booster]
|
13.28 µg/mL
Interval 11.06 to 15.95
|
13.03 µg/mL
Interval 10.95 to 15.5
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-18C [pre-booster]
|
0.78 µg/mL
Interval 0.66 to 0.94
|
0.83 µg/mL
Interval 0.69 to 1.01
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-18C [post-booster]
|
24.19 µg/mL
Interval 20.66 to 28.33
|
19.80 µg/mL
Interval 17.02 to 23.03
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-19F [pre-booster]
|
0.97 µg/mL
Interval 0.82 to 1.14
|
1.11 µg/mL
Interval 0.87 to 1.41
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-19F [post-booster]
|
20.55 µg/mL
Interval 17.62 to 23.98
|
19.68 µg/mL
Interval 17.22 to 22.51
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Anti-23F [pre-booster]
|
0.47 µg/mL
Interval 0.38 to 0.59
|
0.65 µg/mL
Interval 0.5 to 0.83
|
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Population: The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=109 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=110 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Anti-6A [pre-booster]
|
0.21 µg/mL
Interval 0.16 to 0.26
|
0.23 µg/mL
Interval 0.18 to 0.28
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Anti-6A [post-booster]
|
1.99 µg/mL
Interval 1.6 to 2.49
|
2.13 µg/mL
Interval 1.7 to 2.66
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Anti-19A [pre-booster]
|
0.20 µg/mL
Interval 0.15 to 0.25
|
0.18 µg/mL
Interval 0.14 to 0.22
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Anti-19A [post-booster]
|
2.96 µg/mL
Interval 2.26 to 3.87
|
2.13 µg/mL
Interval 1.65 to 2.76
|
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Population: The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=115 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=113 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Protein D (PD).
Anti-PD [post-booster]
|
3115.9 EU/mL
Interval 2634.7 to 3685.1
|
3631.3 EU/mL
Interval 3149.2 to 4187.2
|
|
Concentrations of Antibodies Against Protein D (PD).
Anti-PD [pre-booster]
|
618.4 EU/mL
Interval 527.8 to 724.6
|
794.9 EU/mL
Interval 686.3 to 920.7
|
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Population: The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=55 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=52 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Diphtheria and Tetanus.
Anti-diphtheria [pre-booster]
|
0.29 IU/mL
Interval 0.23 to 0.37
|
0.31 IU/mL
Interval 0.25 to 0.39
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus.
Anti-diphtheria [post-booster]
|
10.89 IU/mL
Interval 9.16 to 12.94
|
8.17 IU/mL
Interval 6.72 to 9.94
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus.
Anti-tetanus [pre-booster]
|
0.46 IU/mL
Interval 0.37 to 0.58
|
0.52 IU/mL
Interval 0.43 to 0.62
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus.
Anti-tetanus [post-booster]
|
14.73 IU/mL
Interval 12.75 to 17.01
|
14.35 IU/mL
Interval 12.41 to 16.6
|
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Population: The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=55 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=52 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-FHA [post-booster]
|
484.3 EU/mL
Interval 418.9 to 559.9
|
358.3 EU/mL
Interval 290.5 to 442.0
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-PT [pre-booster]
|
6.8 EU/mL
Interval 4.9 to 9.3
|
5.8 EU/mL
Interval 4.5 to 7.3
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-PT [post-booster]
|
86.0 EU/mL
Interval 67.9 to 108.9
|
80.8 EU/mL
Interval 65.6 to 99.4
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-FHA [pre-booster]
|
29.6 EU/mL
Interval 21.5 to 40.7
|
19.3 EU/mL
Interval 14.8 to 25.2
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-PRN [pre-booster]
|
15.4 EU/mL
Interval 11.3 to 21.0
|
15.0 EU/mL
Interval 10.7 to 20.9
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Anti-PRN [post-booster]
|
509.5 EU/mL
Interval 387.0 to 670.9
|
314.3 EU/mL
Interval 229.6 to 430.2
|
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Population: The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=55 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=53 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Anti-PRP [pre-booster]
|
0.84 µg/mL
Interval 0.64 to 1.12
|
0.66 µg/mL
Interval 0.48 to 0.9
|
|
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Anti-PRP [post-booster]
|
49.36 µg/mL
Interval 37.4 to 65.15
|
58.26 µg/mL
Interval 43.71 to 77.66
|
SECONDARY outcome
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)Population: The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.
Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
Outcome measures
| Measure |
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=27 Participants
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=28 Participants
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 2 [pre-booster]
|
34.9 Titers
Interval 18.8 to 64.7
|
38.0 Titers
Interval 25.7 to 56.4
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 1 [pre-booster]
|
32.8 Titers
Interval 19.1 to 56.3
|
44.2 Titers
Interval 25.3 to 77.1
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 1 [post-booster]
|
985.2 Titers
Interval 627.9 to 1546.0
|
982.2 Titers
Interval 688.0 to 1402.3
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 2 [post-booster]
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823.4 Titers
Interval 553.5 to 1224.8
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1144.1 Titers
Interval 773.7 to 1691.7
|
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Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 3 [pre-booster]
|
43.3 Titers
Interval 24.0 to 78.0
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41.0 Titers
Interval 24.2 to 69.7
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Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Anti-polio 3 [post-booster]
|
1527.4 Titers
Interval 1016.6 to 2294.7
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1350.8 Titers
Interval 857.4 to 2128.2
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Adverse Events
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
Serious events: 4 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=118 participants at risk
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=120 participants at risk
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/118 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
1.7%
2/120 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/118 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
0.83%
1/120 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/118 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
0.83%
1/120 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/118 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
0.83%
1/120 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/118 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
0.83%
1/120 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
Other adverse events
| Measure |
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
n=118 participants at risk
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
n=120 participants at risk
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
7/118 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
4.2%
5/120 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
4/118 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
5.0%
6/120 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
General disorders
Pain
|
52.1%
61/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
59.8%
70/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
General disorders
Redness
|
56.4%
66/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
52.1%
61/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
General disorders
Swelling
|
38.5%
45/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
41.9%
49/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
General disorders
Drowsiness
|
32.5%
38/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
41.9%
49/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
General disorders
Fever
|
47.9%
56/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
64.1%
75/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
General disorders
Irritability
|
43.6%
51/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
57.3%
67/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
|
General disorders
Loss of appetite
|
35.9%
42/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
|
41.9%
49/117 • Solicited AEs: Within 4 days (Days 0-3) after booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
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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