Trial Outcomes & Findings for Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule (NCT NCT00513409)
NCT ID: NCT00513409
Last Updated: 2018-12-19
Results Overview
Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
163 participants
Primary outcome timeframe
Within 4 days after the administration of any study vaccine dose
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
Synflorix Booster Group
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
79
|
|
Overall Study
COMPLETED
|
82
|
73
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Synflorix Booster Group
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Visit 3 not done
|
1
|
2
|
Baseline Characteristics
Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule
Baseline characteristics by cohort
| Measure |
Synflorix Booster Group
n=84 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=79 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.3 Months
STANDARD_DEVIATION 0.44 • n=93 Participants
|
18.3 Months
STANDARD_DEVIATION 0.50 • n=4 Participants
|
18.3 Months
STANDARD_DEVIATION 0.47 • n=27 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Within 4 days after the administration of any study vaccine dosePopulation: Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
Outcome measures
| Measure |
Synflorix Booster Group
n=84 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=78 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
Any symptoms
|
32 subjects
|
36 subjects
|
|
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
General symptoms
|
6 subjects
|
14 subjects
|
|
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
Local symptoms
|
30 subjects
|
32 subjects
|
SECONDARY outcome
Timeframe: Within 4 days after the administration of any study vaccine dosePopulation: Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
Solicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
Synflorix Booster Group
n=84 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=78 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
57 subjects
|
63 subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
49 subjects
|
52 subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
44 subjects
|
47 subjects
|
SECONDARY outcome
Timeframe: Within 4 days after the administration of any study vaccine dosePopulation: Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius.
Outcome measures
| Measure |
Synflorix Booster Group
n=84 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=78 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Drowsiness
|
33 subjects
|
36 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Fever
|
30 subjects
|
40 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Irritability
|
56 subjects
|
55 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Loss of appetite
|
35 subjects
|
37 subjects
|
SECONDARY outcome
Timeframe: Within 31 days after the administration of any study vaccine doseAn Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Synflorix Booster Group
n=84 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=79 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events
|
47 subjects
|
47 subjects
|
SECONDARY outcome
Timeframe: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Synflorix Booster Group
n=84 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=79 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study
|
1 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Synflorix Booster Group
n=84 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=79 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period
|
1 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the administration of Dose 2Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
Outcome measures
| Measure |
Synflorix Booster Group
n=80 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=73 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-1 Pre (N=79; 72)
|
43 subjects
|
1 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-1 Post (N=78; 70)
|
78 subjects
|
70 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-4 Pre (N=75; 73)
|
45 subjects
|
3 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-4 Post (N=77; 70)
|
77 subjects
|
70 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-5 Pre (N=76; 70)
|
58 subjects
|
7 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-5 Post (N=78; 70)
|
77 subjects
|
70 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-6A Pre (N=76; 72)
|
66 subjects
|
36 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-6A Post (N=77; 70)
|
71 subjects
|
64 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-6B Pre (N=76; 73)
|
55 subjects
|
1 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-6B Post (N=78; 70)
|
76 subjects
|
59 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-7F Pre (N=70; 68)
|
60 subjects
|
8 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-7F Post (N=78; 70)
|
77 subjects
|
70 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-9V Pre (N=78; 72)
|
71 subjects
|
6 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-9V Post (N=79; 70)
|
79 subjects
|
69 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-14 Pre (N=76; 71)
|
69 subjects
|
20 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-14 Post (N=79; 70)
|
79 subjects
|
70 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-18C Pre (N=77; 73)
|
68 subjects
|
5 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-18C Post (N=78; 70)
|
78 subjects
|
70 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-19A Pre (N=78; 73)
|
72 subjects
|
50 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-19A Post (N=78; 70)
|
78 subjects
|
70 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-19F Pre (N=80; 72)
|
76 subjects
|
19 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-19F Post (N=78; 70)
|
78 subjects
|
70 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-23F Pre (N=76; 71)
|
59 subjects
|
3 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-23F Post (N=78; 70)
|
78 subjects
|
66 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the administration of Dose 2Population: Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
Outcome measures
| Measure |
Synflorix Booster Group
n=29 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=28 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-4 Post (N=24; 18)
|
24 subjects
|
18 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-1 Pre (N=28; 25)
|
12 subjects
|
1 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-1 Post (N=25; 25)
|
25 subjects
|
13 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-4 Pre (N=17; 19)
|
7 subjects
|
1 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-5 Pre (N=19; 23)
|
13 subjects
|
1 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-5 Post (N=20; 25)
|
20 subjects
|
21 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-6A Pre (N=20; 25)
|
12 subjects
|
2 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-6A Post (N=19; 19)
|
14 subjects
|
12 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-6B Pre (N=22; 25)
|
12 subjects
|
3 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-6B Post (N=24; 27)
|
22 subjects
|
13 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-7F Pre (N=17; 12)
|
16 subjects
|
4 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-7F Post (N=25; 26)
|
25 subjects
|
26 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-9V Pre (N=20; 17)
|
20 subjects
|
11 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-9V Post (N=23; 23)
|
23 subjects
|
22 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-14 Pre (N=16; 11)
|
14 subjects
|
5 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-14 Post (N=21; 25)
|
21 subjects
|
25 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-18C Pre (N=29; 28)
|
12 subjects
|
3 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-18C Post (N=26; 27)
|
25 subjects
|
27 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-19A Pre (N=18; 18)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-19A Post (N=23; 19)
|
14 subjects
|
5 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-19F Pre (N=22; 23)
|
17 subjects
|
2 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-19F Post (N=20; 21)
|
20 subjects
|
20 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-23F Pre (N=21; 16)
|
18 subjects
|
8 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-23F Post (N=25; 25)
|
25 subjects
|
25 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the administration of Dose 2Population: Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Outcome measures
| Measure |
Synflorix Booster Group
n=77 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=70 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Pre (N= 73; 69)
|
72 subjects
|
44 subjects
|
|
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Post (N= 77; 70)
|
77 subjects
|
70 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the administration of Dose 2Population: Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Synflorix Booster Group
n=19 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=21 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Anti-hepatitis A Virus Antibodies Concentration
Pre (N=18; 21)
|
30.3 mIU/mL
Interval 16.3 to 56.3
|
539.9 mIU/mL
Interval 231.0 to 1261.9
|
|
Anti-hepatitis A Virus Antibodies Concentration
Post (N=19; 19)
|
495.5 mIU/mL
Interval 228.0 to 1076.7
|
478.5 mIU/mL
Interval 199.4 to 1148.2
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the administration of Dose 2Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results.
Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.
Outcome measures
| Measure |
Synflorix Booster Group
n=19 Participants
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=21 Participants
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value
Pre (N=18; 21)
|
12 subjects
|
21 subjects
|
|
Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value
Post (N=19; 19)
|
18 subjects
|
19 subjects
|
Adverse Events
Synflorix Booster Group
Serious events: 1 serious events
Other events: 78 other events
Deaths: 0 deaths
Synflorix Catch-up Group
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synflorix Booster Group
n=84 participants at risk
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=79 participants at risk
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.2%
1/84
|
0.00%
0/79
|
Other adverse events
| Measure |
Synflorix Booster Group
n=84 participants at risk
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
Synflorix Catch-up Group
n=79 participants at risk
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
17.9%
15/84
|
20.3%
16/79
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
6/84
|
17.7%
14/79
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
6/84
|
10.1%
8/79
|
|
General disorders
Injection site induration
|
8.3%
7/84
|
8.9%
7/79
|
|
Infections and infestations
Rhinitis
|
6.0%
5/84
|
5.1%
4/79
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
5/84
|
2.5%
2/79
|
|
General disorders
Pain
|
67.9%
57/84
|
79.7%
63/79
|
|
General disorders
Redness
|
58.3%
49/84
|
65.8%
52/79
|
|
General disorders
Swelling
|
52.4%
44/84
|
59.5%
47/79
|
|
General disorders
Drowsiness
|
39.3%
33/84
|
45.6%
36/79
|
|
General disorders
Fever (Rectally)
|
35.7%
30/84
|
50.6%
40/79
|
|
General disorders
Irritability
|
66.7%
56/84
|
69.6%
55/79
|
|
General disorders
Loss of appetite
|
41.7%
35/84
|
46.8%
37/79
|
|
Infections and infestations
Pharyngitis
|
7.1%
6/84
|
10.1%
8/79
|
|
General disorders
Pyrexia
|
4.8%
4/84
|
6.3%
5/79
|
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