Trial Outcomes & Findings for Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A (NCT NCT00496015)
NCT ID: NCT00496015
Last Updated: 2019-01-18
Results Overview
The cut-off for core fever was 38.0 degrees Celsius (ºC).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
750 participants
Primary outcome timeframe
Within 4 days (Day 0-3) after primary vaccine dose.
Results posted on
2019-01-18
Participant Flow
This was a multicenter study with the same centers as the primary vaccination study 10PN-PD-DIT-010 (107017/NCT00370318) and all subjects enrolled in the primary vaccination study and having received Synflorix vaccine were invited to participate in the study. In addition, an age-matched pneumococcal vaccine unprimed control group has been enrolled.
Participant milestones
| Measure |
Synflorix I Group
Subjects were vaccinated with 3 primary vaccination doses of Synflorix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
178
|
27
|
172
|
37
|
336
|
|
Overall Study
COMPLETED
|
177
|
27
|
172
|
36
|
336
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Synflorix I Group
Subjects were vaccinated with 3 primary vaccination doses of Synflorix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A
Baseline characteristics by cohort
| Measure |
Synflorix I Group
n=178 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=172 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=336 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
12.6 Months
STANDARD_DEVIATION 0.77 • n=5 Participants
|
13.2 Months
STANDARD_DEVIATION 0.74 • n=7 Participants
|
12.7 Months
STANDARD_DEVIATION 0.77 • n=5 Participants
|
13.1 Months
STANDARD_DEVIATION 1.15 • n=4 Participants
|
13.1 Months
STANDARD_DEVIATION 1.1 • n=21 Participants
|
12.6 Months
STANDARD_DEVIATION 0.77 • n=8 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
353 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
397 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Arabic/North African heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian / European heritage
|
177 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
327 Participants
n=21 Participants
|
740 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Other - African + White-Caucasian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Within 4 days (Day 0-3) after primary vaccine dose.Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
The cut-off for core fever was 38.0 degrees Celsius (ºC).
Outcome measures
| Measure |
Synflorix I Group
n=178 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=172 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=336 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off
|
64 Participants
|
14 Participants
|
100 Participants
|
16 Participants
|
146 Participants
|
SECONDARY outcome
Timeframe: Within 4 days (Day 0-3) after primary vaccination dosePopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
The cut-off value for core fever (rectal temperature) was 39.0ºC.
Outcome measures
| Measure |
Synflorix I Group
n=178 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=172 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=336 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
|
4 Participants
|
0 Participants
|
14 Participants
|
1 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-primary vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling \> 30 millimeters (mm) from injection site.
Outcome measures
| Measure |
Synflorix I Group
n=178 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=172 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=336 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
54 Participants
|
10 Participants
|
79 Participants
|
19 Participants
|
114 Participants
|
|
Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
2 Participants
|
2 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
89 Participants
|
9 Participants
|
74 Participants
|
12 Participants
|
146 Participants
|
|
Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Redness
|
7 Participants
|
1 Participants
|
14 Participants
|
1 Participants
|
16 Participants
|
|
Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
52 Participants
|
8 Participants
|
50 Participants
|
13 Participants
|
71 Participants
|
|
Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Swelling
|
2 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature \>40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Synflorix I Group
n=178 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=172 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=336 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
91 Participants
|
11 Participants
|
84 Participants
|
18 Participants
|
146 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
84 Participants
|
11 Participants
|
79 Participants
|
18 Participants
|
120 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (rectal temperature ≥ 38.0°C)
|
64 Participants
|
14 Participants
|
100 Participants
|
16 Participants
|
146 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (rectal temperature > 40.0°C)
|
62 Participants
|
14 Participants
|
99 Participants
|
16 Participants
|
140 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (rectal temperature > 40.0°C)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability
|
86 Participants
|
17 Participants
|
105 Participants
|
19 Participants
|
147 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability
|
80 Participants
|
17 Participants
|
98 Participants
|
18 Participants
|
129 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite
|
47 Participants
|
8 Participants
|
46 Participants
|
10 Participants
|
88 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite
|
42 Participants
|
7 Participants
|
41 Participants
|
10 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Within 31 days (Days 0-30) after primary vaccine dose.Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Synflorix I Group
n=178 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=209 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects Reported With Unsolicited Adverse Events (AEs)
|
22 Participants
|
3 Participants
|
64 Participants
|
30 Participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the entire study period (Month 0-Month 12)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Synflorix I Group
n=178 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=172 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=336 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects Reported With Serious Adverse Events (SAEs)
|
13 Participants
|
5 Participants
|
13 Participants
|
4 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after vaccination with Mencevax™Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled in.
Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.
Outcome measures
| Measure |
Synflorix I Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.
Subject(s) with any rash(es)
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.
Subject(s) with any NOCI(s)
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.
Subject(s) with any ER visit(s)
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.
Subject(s) with any visit(s) at physician office
|
53 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccinationPopulation: The analysis were performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Synflorix I Group
n=141 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=25 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=168 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=289 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-1 PRE
|
74 Participants
|
14 Participants
|
115 Participants
|
27 Participants
|
6 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-4 M1
|
141 Participants
|
24 Participants
|
167 Participants
|
37 Participants
|
6 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-9V M12
|
129 Participants
|
20 Participants
|
166 Participants
|
35 Participants
|
30 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-14 PRE
|
131 Participants
|
22 Participants
|
159 Participants
|
35 Participants
|
25 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-1 M1
|
140 Participants
|
24 Participants
|
167 Participants
|
36 Participants
|
5 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-1 M12
|
89 Participants
|
11 Participants
|
122 Participants
|
30 Participants
|
11 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-4 PRE
|
123 Participants
|
15 Participants
|
147 Participants
|
31 Participants
|
6 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-4 M12
|
103 Participants
|
14 Participants
|
147 Participants
|
27 Participants
|
20 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-5 PRE
|
102 Participants
|
15 Participants
|
142 Participants
|
30 Participants
|
6 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-5 M1
|
140 Participants
|
23 Participants
|
167 Participants
|
36 Participants
|
10 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-5 M12
|
113 Participants
|
18 Participants
|
159 Participants
|
30 Participants
|
31 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-6B PRE
|
110 Participants
|
13 Participants
|
143 Participants
|
32 Participants
|
1 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-6B M1
|
134 Participants
|
21 Participants
|
166 Participants
|
35 Participants
|
1 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-6B M12
|
97 Participants
|
18 Participants
|
148 Participants
|
30 Participants
|
21 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-7F PRE
|
130 Participants
|
21 Participants
|
156 Participants
|
34 Participants
|
5 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-7F M1
|
140 Participants
|
25 Participants
|
167 Participants
|
37 Participants
|
9 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-7F M12
|
132 Participants
|
21 Participants
|
165 Participants
|
36 Participants
|
20 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-9V PRE
|
117 Participants
|
20 Participants
|
152 Participants
|
34 Participants
|
5 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-9V M1
|
141 Participants
|
24 Participants
|
167 Participants
|
37 Participants
|
10 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-14 M1
|
140 Participants
|
24 Participants
|
166 Participants
|
36 Participants
|
29 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-14 M12
|
131 Participants
|
21 Participants
|
166 Participants
|
34 Participants
|
63 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-18C PRE
|
118 Participants
|
14 Participants
|
154 Participants
|
29 Participants
|
8 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-18C M1
|
141 Participants
|
25 Participants
|
167 Participants
|
37 Participants
|
9 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-18C M12
|
113 Participants
|
18 Participants
|
157 Participants
|
35 Participants
|
29 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-19F PRE
|
128 Participants
|
21 Participants
|
163 Participants
|
36 Participants
|
17 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-19F M1
|
138 Participants
|
25 Participants
|
165 Participants
|
37 Participants
|
24 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-19F M12
|
135 Participants
|
22 Participants
|
165 Participants
|
36 Participants
|
90 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-23F PRE
|
103 Participants
|
14 Participants
|
132 Participants
|
30 Participants
|
2 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-23F M1
|
135 Participants
|
21 Participants
|
163 Participants
|
36 Participants
|
4 Participants
|
|
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
ANTI-23F M12
|
115 Participants
|
16 Participants
|
154 Participants
|
33 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccinationPopulation: The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
Certain pneumococcal serotypes included pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Synflorix I Group
n=141 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=25 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=168 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=289 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-18C PRE
|
0.47 μg/mL
Interval 0.41 to 0.54
|
0.29 μg/mL
Interval 0.2 to 0.43
|
0.78 μg/mL
Interval 0.69 to 0.89
|
0.54 μg/mL
Interval 0.39 to 0.76
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-18C M1
|
4.96 μg/mL
Interval 4.4 to 5.6
|
3.46 μg/mL
Interval 2.35 to 5.09
|
7 μg/mL
Interval 6.28 to 7.79
|
6.13 μg/mL
Interval 4.85 to 7.75
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-18C M12
|
0.56 μg/mL
Interval 0.47 to 0.66
|
0.44 μg/mL
Interval 0.27 to 0.72
|
1.05 μg/mL
Interval 0.92 to 1.21
|
0.92 μg/mL
Interval 0.69 to 1.21
|
0.04 μg/mL
Interval 0.04 to 0.05
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-19F PRE
|
0.98 μg/mL
Interval 0.81 to 1.19
|
0.63 μg/mL
Interval 0.39 to 1.02
|
1.48 μg/mL
Interval 1.27 to 1.73
|
1.4 μg/mL
Interval 1.0 to 1.97
|
0.03 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-19F M1
|
6 μg/mL
Interval 5.08 to 7.08
|
4.84 μg/mL
Interval 3.47 to 6.77
|
7.55 μg/mL
Interval 6.48 to 8.79
|
8.77 μg/mL
Interval 6.68 to 11.53
|
0.05 μg/mL
Interval 0.04 to 0.05
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-19F M12
|
1.46 μg/mL
Interval 1.18 to 1.82
|
0.82 μg/mL
Interval 0.56 to 1.2
|
1.8 μg/mL
Interval 1.52 to 2.13
|
2.04 μg/mL
Interval 1.41 to 2.94
|
0.12 μg/mL
Interval 0.1 to 0.14
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-23F PRE
|
0.38 μg/mL
Interval 0.31 to 0.46
|
0.3 μg/mL
Interval 0.16 to 0.58
|
0.54 μg/mL
Interval 0.45 to 0.64
|
0.45 μg/mL
Interval 0.31 to 0.65
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-23F M1
|
1.99 μg/mL
Interval 1.67 to 2.38
|
1.33 μg/mL
Interval 0.64 to 2.78
|
2.92 μg/mL
Interval 2.5 to 3.4
|
3.86 μg/mL
Interval 2.52 to 5.91
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-23F M12
|
0.46 μg/mL
Interval 0.38 to 0.56
|
0.29 μg/mL
Interval 0.16 to 0.52
|
0.8 μg/mL
Interval 0.67 to 0.95
|
0.98 μg/mL
Interval 0.69 to 1.39
|
0.04 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-1 M1
|
1.67 μg/mL
Interval 1.47 to 1.9
|
1.64 μg/mL
Interval 1.08 to 2.47
|
2.62 μg/mL
Interval 2.3 to 2.99
|
2.97 μg/mL
Interval 2.21 to 3.99
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-1 PRE
|
0.22 μg/mL
Interval 0.19 to 0.25
|
0.18 μg/mL
Interval 0.12 to 0.27
|
0.31 μg/mL
Interval 0.27 to 0.35
|
0.26 μg/mL
Interval 0.19 to 0.35
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-1 M12
|
0.26 μg/mL
Interval 0.22 to 0.31
|
0.18 μg/mL
Interval 0.12 to 0.29
|
0.39 μg/mL
Interval 0.34 to 0.45
|
0.41 μg/mL
Interval 0.31 to 0.56
|
0.04 μg/mL
Interval 0.04 to 0.04
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-4 PRE
|
0.4 μg/mL
Interval 0.35 to 0.45
|
0.24 μg/mL
Interval 0.17 to 0.35
|
0.6 μg/mL
Interval 0.52 to 0.69
|
0.45 μg/mL
Interval 0.35 to 0.58
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-4 M1
|
3.01 μg/mL
Interval 2.69 to 3.36
|
2.84 μg/mL
Interval 1.98 to 4.08
|
4.21 μg/mL
Interval 3.72 to 4.76
|
3.95 μg/mL
Interval 2.97 to 5.26
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-4 M12
|
0.34 μg/mL
Interval 0.29 to 0.39
|
0.21 μg/mL
Interval 0.13 to 0.33
|
0.5 μg/mL
Interval 0.43 to 0.56
|
0.55 μg/mL
Interval 0.39 to 0.78
|
0.04 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-5 PRE
|
0.36 μg/mL
Interval 0.32 to 0.42
|
0.31 μg/mL
Interval 0.18 to 0.52
|
0.59 μg/mL
Interval 0.52 to 0.68
|
0.53 μg/mL
Interval 0.36 to 0.78
|
0.04 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-5 M1
|
2.3 μg/mL
Interval 2.04 to 2.6
|
2 μg/mL
Interval 1.31 to 3.06
|
3.68 μg/mL
Interval 3.26 to 4.15
|
3.03 μg/mL
Interval 2.16 to 4.26
|
0.04 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-5 M12
|
0.42 μg/mL
Interval 0.36 to 0.48
|
0.35 μg/mL
Interval 0.23 to 0.52
|
0.72 μg/mL
Interval 0.63 to 0.83
|
0.58 μg/mL
Interval 0.42 to 0.81
|
0.06 μg/mL
Interval 0.05 to 0.06
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-6B PRE
|
0.35 μg/mL
Interval 0.3 to 0.41
|
0.18 μg/mL
Interval 0.1 to 0.32
|
0.55 μg/mL
Interval 0.48 to 0.63
|
0.5 μg/mL
Interval 0.35 to 0.72
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-6B M1
|
1.35 μg/mL
Interval 1.12 to 1.61
|
0.89 μg/mL
Interval 0.46 to 1.72
|
2.45 μg/mL
Interval 2.17 to 2.77
|
2.25 μg/mL
Interval 1.51 to 3.33
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-6B M12
|
0.4 μg/mL
Interval 0.32 to 0.5
|
0.36 μg/mL
Interval 0.19 to 0.66
|
0.56 μg/mL
Interval 0.47 to 0.68
|
0.54 μg/mL
Interval 0.37 to 0.81
|
0.04 μg/mL
Interval 0.04 to 0.04
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-7F PRE
|
0.74 μg/mL
Interval 0.65 to 0.84
|
0.55 μg/mL
Interval 0.4 to 0.76
|
1.05 μg/mL
Interval 0.93 to 1.18
|
0.87 μg/mL
Interval 0.66 to 1.13
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-7F M1
|
2.9 μg/mL
Interval 2.59 to 3.25
|
2.37 μg/mL
Interval 1.86 to 3.03
|
4.13 μg/mL
Interval 3.69 to 4.63
|
4.38 μg/mL
Interval 3.35 to 5.72
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-7F M12
|
0.68 μg/mL
Interval 0.6 to 0.78
|
0.45 μg/mL
Interval 0.32 to 0.63
|
0.91 μg/mL
Interval 0.82 to 1.02
|
0.96 μg/mL
Interval 0.74 to 1.24
|
0.04 μg/mL
Interval 0.04 to 0.04
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-9V PRE
|
0.61 μg/mL
Interval 0.53 to 0.7
|
0.59 μg/mL
Interval 0.33 to 1.05
|
1 μg/mL
Interval 0.88 to 1.13
|
0.99 μg/mL
Interval 0.78 to 1.26
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-9V M1
|
2.86 μg/mL
Interval 2.52 to 3.23
|
2.57 μg/mL
Interval 1.73 to 3.81
|
4.39 μg/mL
Interval 3.91 to 4.94
|
4.35 μg/mL
Interval 3.3 to 5.73
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-9V M12
|
0.67 μg/mL
Interval 0.56 to 0.8
|
0.55 μg/mL
Interval 0.33 to 0.92
|
0.97 μg/mL
Interval 0.85 to 1.12
|
0.86 μg/mL
Interval 0.64 to 1.17
|
0.04 μg/mL
Interval 0.04 to 0.05
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-14 PRE
|
0.82 μg/mL
Interval 0.69 to 0.96
|
0.52 μg/mL
Interval 0.36 to 0.74
|
1.57 μg/mL
Interval 1.32 to 1.86
|
1.27 μg/mL
Interval 0.86 to 1.88
|
0.04 μg/mL
Interval 0.04 to 0.05
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-14 M1
|
4.58 μg/mL
Interval 4.05 to 5.18
|
4.37 μg/mL
Interval 3.01 to 6.33
|
5.95 μg/mL
Interval 5.28 to 6.71
|
5.86 μg/mL
Interval 4.35 to 7.89
|
0.05 μg/mL
Interval 0.04 to 0.05
|
|
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
ANTI-14 M12
|
0.89 μg/mL
Interval 0.73 to 1.09
|
0.94 μg/mL
Interval 0.48 to 1.84
|
1.54 μg/mL
Interval 1.3 to 1.81
|
1.25 μg/mL
Interval 0.9 to 1.76
|
0.11 μg/mL
Interval 0.09 to 0.13
|
SECONDARY outcome
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccinationPopulation: The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.
Outcome measures
| Measure |
Synflorix I Group
n=131 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=25 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=161 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=35 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=135 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-23F M12
|
386.4 Titers
Interval 250.0 to 597.2
|
433.8 Titers
Interval 110.1 to 1709.8
|
857.5 Titers
Interval 634.0 to 1159.7
|
670.2 Titers
Interval 331.9 to 1353.3
|
147.1 Titers
Interval 86.7 to 249.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-1 PRE
|
6.1 Titers
Interval 5.0 to 7.4
|
5.6 Titers
Interval 4.0 to 8.0
|
8.1 Titers
Interval 6.6 to 10.0
|
6 Titers
Interval 4.2 to 8.5
|
4.9 Titers
Interval 3.7 to 6.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-1 M1
|
144.6 Titers
Interval 109.6 to 190.6
|
193.4 Titers
Interval 95.8 to 390.8
|
417 Titers
Interval 330.6 to 526.2
|
325 Titers
Interval 178.8 to 590.7
|
5.1 Titers
Interval 4.1 to 6.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-1 M12
|
12.8 Titers
Interval 10.0 to 16.5
|
12.5 Titers
Interval 6.8 to 23.2
|
23.1 Titers
Interval 18.2 to 29.2
|
20.5 Titers
Interval 13.1 to 32.3
|
4.7 Titers
Interval 4.3 to 5.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-4 PRE
|
23.8 Titers
Interval 16.5 to 34.2
|
8.8 Titers
Interval 5.2 to 14.9
|
44.9 Titers
Interval 33.2 to 60.8
|
29.7 Titers
Interval 14.3 to 61.6
|
5.9 Titers
Interval 3.4 to 10.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-4 M1
|
1547.9 Titers
Interval 1357.9 to 1764.4
|
971.6 Titers
Interval 615.8 to 1532.7
|
2297 Titers
Interval 2005.8 to 2630.4
|
1303.2 Titers
Interval 918.6 to 1849.0
|
7.8 Titers
Interval 3.6 to 16.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-4 M12
|
19.9 Titers
Interval 13.9 to 28.6
|
14.9 Titers
Interval 6.4 to 34.8
|
51.2 Titers
Interval 36.2 to 72.4
|
72.5 Titers
Interval 33.7 to 156.1
|
6.8 Titers
Interval 5.0 to 9.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-5 PRE
|
8.5 Titers
Interval 7.0 to 10.4
|
10.4 Titers
Interval 6.2 to 17.4
|
16.6 Titers
Interval 13.2 to 20.9
|
15.1 Titers
Interval 8.8 to 25.9
|
4.2 Titers
Interval 3.8 to 4.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-5 M1
|
134.3 Titers
Interval 109.8 to 164.2
|
105 Titers
Interval 55.9 to 196.9
|
289.3 Titers
Interval 243.5 to 343.7
|
227.7 Titers
Interval 130.7 to 396.6
|
4.3 Titers
Interval 3.8 to 4.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-5 M12
|
10.3 Titers
Interval 8.3 to 12.9
|
10.5 Titers
Interval 5.9 to 18.7
|
23.7 Titers
Interval 18.9 to 29.8
|
15.4 Titers
Interval 10.2 to 23.2
|
4 Titers
Interval 4.0 to 4.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-6B PRE
|
32.5 Titers
Interval 21.6 to 48.9
|
15.9 Titers
Interval 6.0 to 42.1
|
45.2 Titers
Interval 32.9 to 62.2
|
49.7 Titers
Interval 23.0 to 107.3
|
9.9 Titers
Interval 3.5 to 27.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-6B M1
|
496.7 Titers
Interval 351.4 to 702.2
|
148.3 Titers
Interval 46.5 to 472.5
|
985.7 Titers
Interval 807.1 to 1203.9
|
718.3 Titers
Interval 445.7 to 1157.5
|
20.9 Titers
Interval 6.6 to 65.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-6B M12
|
46.9 Titers
Interval 29.6 to 74.2
|
97.7 Titers
Interval 27.7 to 345.1
|
53.9 Titers
Interval 36.1 to 80.4
|
29.4 Titers
Interval 13.2 to 65.2
|
19.1 Titers
Interval 12.0 to 30.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-7F PRE
|
413.6 Titers
Interval 266.1 to 642.9
|
221.4 Titers
Interval 65.7 to 745.9
|
584.7 Titers
Interval 426.1 to 802.3
|
258.4 Titers
Interval 119.9 to 556.7
|
90 Titers
Interval 23.2 to 349.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-7F M1
|
4025.8 Titers
Interval 3457.3 to 4687.9
|
1749 Titers
Interval 1144.2 to 2673.4
|
4674.7 Titers
Interval 4102.2 to 5327.0
|
2212.2 Titers
Interval 1569.1 to 3118.7
|
267.3 Titers
Interval 89.1 to 801.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-7F M12
|
1503.3 Titers
Interval 1209.1 to 1869.2
|
1606.4 Titers
Interval 1101.4 to 2343.0
|
1285.7 Titers
Interval 1050.8 to 1573.0
|
1738.3 Titers
Interval 1330.6 to 2271.0
|
681.1 Titers
Interval 499.7 to 928.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-9V PRE
|
420.7 Titers
Interval 342.7 to 516.5
|
472.9 Titers
Interval 255.6 to 874.7
|
407.7 Titers
Interval 340.3 to 488.4
|
365.7 Titers
Interval 240.6 to 555.8
|
69.2 Titers
Interval 22.9 to 208.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-9V M1
|
2234.8 Titers
Interval 1905.7 to 2620.7
|
752.9 Titers
Interval 476.9 to 1188.8
|
2403.7 Titers
Interval 2092.3 to 2761.4
|
1155.5 Titers
Interval 733.4 to 1820.4
|
87.4 Titers
Interval 45.2 to 169.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-9V M12
|
791.6 Titers
Interval 647.4 to 967.9
|
552.2 Titers
Interval 337.1 to 904.6
|
906.7 Titers
Interval 757.6 to 1085.2
|
716.8 Titers
Interval 481.0 to 1068.2
|
127.2 Titers
Interval 86.8 to 186.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-14 PRE
|
189.7 Titers
Interval 141.7 to 254.0
|
150.2 Titers
Interval 81.5 to 276.8
|
293.2 Titers
Interval 235.3 to 365.5
|
227.4 Titers
Interval 115.1 to 449.4
|
11.5 Titers
Interval 3.3 to 40.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-14 M1
|
1581.7 Titers
Interval 1381.1 to 1811.4
|
1515 Titers
Interval 911.2 to 2519.0
|
1865.2 Titers
Interval 1633.4 to 2129.9
|
1964.5 Titers
Interval 1359.9 to 2837.9
|
158 Titers
Interval 59.4 to 420.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-14 M12
|
434.5 Titers
Interval 353.0 to 534.8
|
438.4 Titers
Interval 137.7 to 1396.0
|
447.5 Titers
Interval 376.0 to 532.6
|
558 Titers
Interval 425.0 to 732.5
|
287.8 Titers
Interval 203.2 to 407.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-18C PRE
|
6.1 Titers
Interval 5.2 to 7.2
|
6 Titers
Interval 3.7 to 9.7
|
11.7 Titers
Interval 9.2 to 15.1
|
9.5 Titers
Interval 4.9 to 18.5
|
4.5 Titers
Interval 3.5 to 5.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-18C M1
|
652.9 Titers
Interval 553.5 to 770.1
|
269.7 Titers
Interval 128.9 to 564.3
|
737.8 Titers
Interval 633.6 to 859.1
|
537.6 Titers
Interval 370.9 to 779.3
|
4 Titers
Interval 4.0 to 4.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-18C M12
|
11.9 Titers
Interval 8.9 to 16.1
|
24.7 Titers
Interval 9.0 to 67.5
|
27.7 Titers
Interval 21.3 to 36.0
|
23.5 Titers
Interval 11.0 to 50.3
|
4.6 Titers
Interval 4.0 to 5.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-19F PRE
|
21.2 Titers
Interval 16.1 to 28.0
|
17.4 Titers
Interval 10.5 to 28.7
|
35.1 Titers
Interval 28.0 to 44.0
|
36.4 Titers
Interval 22.0 to 60.3
|
5.3 Titers
Interval 3.7 to 7.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-19F M1
|
629.4 Titers
Interval 496.6 to 797.7
|
372.9 Titers
Interval 180.1 to 772.5
|
1062.2 Titers
Interval 871.8 to 1294.3
|
1198.8 Titers
Interval 807.1 to 1780.5
|
4.5 Titers
Interval 3.7 to 5.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-19F M12
|
64.3 Titers
Interval 47.6 to 86.7
|
39.4 Titers
Interval 17.3 to 89.5
|
101.3 Titers
Interval 80.7 to 127.0
|
121.3 Titers
Interval 67.5 to 218.1
|
6.4 Titers
Interval 5.1 to 8.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-23F PRE
|
288.7 Titers
Interval 192.1 to 434.0
|
310.1 Titers
Interval 85.9 to 1119.4
|
408 Titers
Interval 288.6 to 576.6
|
305.3 Titers
Interval 135.0 to 690.5
|
20.2 Titers
Interval 7.2 to 56.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPSONO-23F M1
|
2335.7 Titers
Interval 2016.2 to 2705.7
|
1223.1 Titers
Interval 910.6 to 1642.8
|
3154 Titers
Interval 2658.0 to 3742.4
|
1808.7 Titers
Interval 1381.1 to 2368.7
|
261.8 Titers
Interval 97.9 to 700.5
|
SECONDARY outcome
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccinationPopulation: The analyses were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Synflorix I Group
n=140 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=25 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=167 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=270 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD-PRE
|
365.1 EL.U/mL
Interval 302.1 to 441.1
|
356.5 EL.U/mL
Interval 247.0 to 514.4
|
685.5 EL.U/mL
Interval 585.4 to 802.9
|
584.3 EL.U/mL
Interval 393.1 to 868.4
|
65.6 EL.U/mL
Interval 60.9 to 70.8
|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD-M1
|
1654 EL.U/mL
Interval 1399.9 to 1954.4
|
1813.5 EL.U/mL
Interval 1111.5 to 2958.9
|
3134.2 EL.U/mL
Interval 2765.4 to 3552.1
|
2612.3 EL.U/mL
Interval 1804.4 to 3782.1
|
64.6 EL.U/mL
Interval 59.9 to 69.5
|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD-M12
|
468.1 EL.U/mL
Interval 381.8 to 573.8
|
418 EL.U/mL
Interval 259.9 to 672.3
|
834.6 EL.U/mL
Interval 720.0 to 967.5
|
713.4 EL.U/mL
Interval 476.9 to 1067.4
|
74.4 EL.U/mL
Interval 67.8 to 81.6
|
SECONDARY outcome
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccinationPopulation: The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).
Outcome measures
| Measure |
Synflorix I Group
n=139 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=25 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=168 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=288 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)
Anti-19A-M12
|
0.22 μg/mL
Interval 0.17 to 0.28
|
0.13 μg/mL
Interval 0.08 to 0.22
|
0.36 μg/mL
Interval 0.3 to 0.44
|
0.41 μg/mL
Interval 0.26 to 0.65
|
0.06 μg/mL
Interval 0.05 to 0.07
|
|
Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)
Anti-6A-PRE
|
0.12 μg/mL
Interval 0.1 to 0.15
|
0.08 μg/mL
Interval 0.05 to 0.12
|
0.21 μg/mL
Interval 0.18 to 0.26
|
0.19 μg/mL
Interval 0.12 to 0.29
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)
Anti-6A-M1
|
0.4 μg/mL
Interval 0.31 to 0.51
|
0.29 μg/mL
Interval 0.15 to 0.55
|
0.86 μg/mL
Interval 0.69 to 1.07
|
0.75 μg/mL
Interval 0.43 to 1.3
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)
Anti-6A-M12
|
0.14 μg/mL
Interval 0.11 to 0.18
|
0.1 μg/mL
Interval 0.07 to 0.16
|
0.24 μg/mL
Interval 0.2 to 0.3
|
0.2 μg/mL
Interval 0.13 to 0.29
|
0.04 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)
Anti-19A-PRE
|
0.15 μg/mL
Interval 0.13 to 0.18
|
0.12 μg/mL
Interval 0.07 to 0.19
|
0.23 μg/mL
Interval 0.19 to 0.27
|
0.2 μg/mL
Interval 0.14 to 0.29
|
0.03 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)
Anti-19A-M1
|
0.84 μg/mL
Interval 0.67 to 1.05
|
0.56 μg/mL
Interval 0.29 to 1.09
|
1.34 μg/mL
Interval 1.09 to 1.66
|
1.54 μg/mL
Interval 0.98 to 2.43
|
0.04 μg/mL
Interval 0.03 to 0.04
|
SECONDARY outcome
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccinationPopulation: The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.
Outcome measures
| Measure |
Synflorix I Group
n=129 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=22 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=153 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=33 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=131 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
OPSONO-6A-PRE
|
72.4 Titers
Interval 48.3 to 108.4
|
35.6 Titers
Interval 12.2 to 104.1
|
65.4 Titers
Interval 45.7 to 93.7
|
66 Titers
Interval 25.7 to 169.5
|
9.7 Titers
Interval 4.7 to 20.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
OPSONO-6A-M1
|
251.5 Titers
Interval 180.2 to 351.0
|
105.1 Titers
Interval 40.6 to 271.8
|
401.7 Titers
Interval 319.5 to 505.2
|
403.7 Titers
Interval 253.5 to 642.9
|
16.1 Titers
Interval 5.0 to 52.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
OPSONO-6A-M12
|
59.4 Titers
Interval 38.8 to 91.0
|
23 Titers
Interval 8.4 to 62.6
|
52.1 Titers
Interval 35.6 to 76.3
|
37.2 Titers
Interval 17.5 to 79.0
|
17.1 Titers
Interval 11.7 to 24.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
OPSONO-19A-PRE
|
5 Titers
Interval 4.3 to 5.7
|
4.9 Titers
Interval 3.2 to 7.3
|
4.8 Titers
Interval 4.3 to 5.4
|
5 Titers
Interval 3.6 to 6.9
|
4 Titers
Interval 4.0 to 4.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
OPSONO-19A-M1
|
39.2 Titers
Interval 26.4 to 58.2
|
39.7 Titers
Interval 11.5 to 137.4
|
89.7 Titers
Interval 61.2 to 131.6
|
99.6 Titers
Interval 40.8 to 243.1
|
4 Titers
Interval 4.0 to 4.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
OPSONO-19A-M12
|
7 Titers
Interval 5.5 to 8.8
|
4.8 Titers
Interval 3.6 to 6.5
|
8.9 Titers
Interval 7.1 to 11.1
|
9.5 Titers
Interval 5.6 to 16.1
|
4.7 Titers
Interval 4.2 to 5.2
|
SECONDARY outcome
Timeframe: Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).
Outcome measures
| Measure |
Synflorix I Group
n=301 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenA,Pre, ≥ 1:8
|
69 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenA, Pre, ≥ 1:128
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenA, M1, ≥ 1:8
|
298 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenA, M1, ≥ 1:128
|
298 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenA, M12, ≥ 1:8
|
136 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenA, M12, ≥ 1:128
|
134 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenC,Pre, ≥ 1:8
|
50 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenC, Pre, ≥ 1:128
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenC, M1, ≥ 1:8
|
300 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenC, M1, ≥ 1:128
|
294 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenC, M12, ≥ 1:8
|
154 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenC, M12, ≥ 1:128
|
105 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenW-135,Pre, ≥ 1:8
|
114 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenW-135, Pre, ≥ 1:128
|
59 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenW-135, M1, ≥ 1:8
|
301 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenW-135, M1, ≥ 1:128
|
301 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenW-135, M12, ≥ 1:8
|
138 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenW-135, M12, ≥ 1:128
|
129 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenY,Pre, ≥ 1:8
|
167 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenY, Pre, ≥ 1:128
|
93 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenY, M1, ≥ 1:8
|
300 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenY, M1, ≥ 1:128
|
300 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenY, M12, ≥ 1:8
|
137 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
rSBA-MenY, M12, ≥ 1:128
|
127 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).
Outcome measures
| Measure |
Synflorix I Group
n=301 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenW-135, M12
|
573.1 Titers
Interval 479.3 to 685.3
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenA,Pre
|
11.5 Titers
Interval 9.2 to 14.3
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenA, M1
|
2151.3 Titers
Interval 1927.4 to 2401.2
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenA, M12
|
677.6 Titers
Interval 579.9 to 791.8
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenC,Pre
|
6.9 Titers
Interval 6.0 to 8.0
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenC, M1
|
811.2 Titers
Interval 728.0 to 904.0
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenC, M12
|
191.1 Titers
Interval 153.5 to 238.0
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenW-135,Pre
|
16.3 Titers
Interval 13.2 to 20.1
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenW-135, M1
|
5393.6 Titers
Interval 4888.2 to 5951.1
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenY,Pre
|
30.2 Titers
Interval 24.2 to 37.7
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenY, M1
|
2863.7 Titers
Interval 2537.8 to 3231.4
|
—
|
—
|
—
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
rSBA-MenY, M12
|
665.2 Titers
Interval 547.9 to 807.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).
Outcome measures
| Measure |
Synflorix I Group
n=278 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSA PRE ≥ 0.3 μg/mL
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSA PRE ≥ 2.0 μg/mL
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSA M1≥ 0.3 μg/mL
|
271 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSA M1 ≥ 2.0 μg/mL
|
271 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSA M12 ≥ 0.3 μg/mL
|
133 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSA M12 ≥ 2.0 μg/mL
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSC PRE ≥ 0.3 μg/mL
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSC PRE ≥ 2.0 μg/mL
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSC M1 ≥ 0.3 μg/mL
|
278 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSC M1≥ 2.0 μg/mL
|
277 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSC M12 ≥ 0.3 μg/mL
|
94 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSC M12 ≥ 2.0 μg/mL
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSW-135 PRE ≥ 0.3 μg/mL
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSW-135 PRE ≥ 2.0 μg/mL
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSW-135 M1 ≥ 0.3 μg/mL
|
258 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSW-135 M1 ≥ 2.0 μg/mL
|
234 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSW-135 M12 ≥ 0.3 μg/mL
|
117 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSW-135 M12 ≥ 2.0 μg/mL
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSY PRE ≥ 0.3 μg/mL
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSY PRE ≥ 2.0 μg/mL
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSY M1 ≥ 0.3 μg/mL
|
261 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSY M1 ≥ 2.0 μg/mL
|
249 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSY M12 ≥ 0.3 μg/mL
|
131 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
ANTI-PSY M12 ≥ 2.0 μg/mL
|
59 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).
Outcome measures
| Measure |
Synflorix I Group
n=278 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSA, Pre
|
0.16 μg/mL
Interval 0.15 to 0.17
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSA, M1
|
36.28 μg/mL
Interval 32.8 to 40.15
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSA, M12
|
0.99 μg/mL
Interval 0.82 to 1.19
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSC, Pre
|
0.15 μg/mL
Interval 0.15 to 0.16
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSC, M1
|
14.12 μg/mL
Interval 13.0 to 15.32
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSC, M12
|
0.42 μg/mL
Interval 0.36 to 0.49
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSW-135, Pre
|
0.15 μg/mL
Interval 0.15 to 0.15
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSW-135, M1
|
6.11 μg/mL
Interval 5.45 to 6.86
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSW-135, M12
|
1.21 μg/mL
Interval 0.98 to 1.48
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSY, Pre
|
0.15 μg/mL
Interval 0.15 to 0.16
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSY, M1
|
8.03 μg/mL
Interval 7.17 to 8.99
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
Anti-PSY, M12
|
1.81 μg/mL
Interval 1.5 to 2.19
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination (Pre)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Synflorix I Group
n=266 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group
|
0.512 IU/mL
Interval 0.456 to 0.575
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination (Pre)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1.
Outcome measures
| Measure |
Synflorix I Group
n=2 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group
|
1336.1 mIU/mL
Interval 52.3 to 34160.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post-vaccination (M1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Synflorix I Group
n=140 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=24 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=167 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=245 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).
Anti-D, M1
|
10.112 IU/mL
Interval 9.042 to 11.309
|
9.839 IU/mL
Interval 7.475 to 12.95
|
12.285 IU/mL
Interval 11.18 to 13.5
|
11 IU/mL
Interval 8.786 to 13.77
|
7.291 IU/mL
Interval 6.592 to 8.064
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).
Anti-T, M1
|
7.382 IU/mL
Interval 6.639 to 8.208
|
8.684 IU/mL
Interval 6.37 to 11.839
|
9.583 IU/mL
Interval 8.927 to 10.287
|
8.196 IU/mL
Interval 6.829 to 9.837
|
11.79 IU/mL
Interval 10.684 to 13.011
|
SECONDARY outcome
Timeframe: 1 month post-vaccination (M1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL).
Outcome measures
| Measure |
Synflorix I Group
n=140 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=24 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=167 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=251 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-PT, M1
|
83.3 EL.U/mL
Interval 73.8 to 94.0
|
81.6 EL.U/mL
Interval 62.2 to 106.9
|
82 EL.U/mL
Interval 73.4 to 91.7
|
76.7 EL.U/mL
Interval 62.2 to 94.4
|
163.1 EL.U/mL
Interval 143.0 to 185.9
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-FHA, M1
|
467.9 EL.U/mL
Interval 422.4 to 518.3
|
431.1 EL.U/mL
Interval 318.8 to 582.9
|
453.8 EL.U/mL
Interval 412.6 to 499.1
|
400.4 EL.U/mL
Interval 321.8 to 498.2
|
580.8 EL.U/mL
Interval 532.2 to 633.8
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-PRN, M1
|
222.8 EL.U/mL
Interval 193.9 to 256.0
|
153.4 EL.U/mL
Interval 97.5 to 241.2
|
254.9 EL.U/mL
Interval 225.8 to 287.8
|
220.4 EL.U/mL
Interval 168.7 to 288.0
|
350.7 EL.U/mL
Interval 316.8 to 388.3
|
SECONDARY outcome
Timeframe: 1 month post-vaccination (M1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seroprotection cut-off for the assay was ≥ 10 mIU/mL.
Outcome measures
| Measure |
Synflorix I Group
n=105 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=16 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=130 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=26 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=1 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
|
1883.9 mIU/mL
Interval 1332.9 to 2662.7
|
1460.6 mIU/mL
Interval 816.4 to 2613.2
|
2133 mIU/mL
Interval 1615.0 to 2817.1
|
1818.5 mIU/mL
Interval 1142.8 to 2893.6
|
20610 mIU/mL
As there was only 1 subject analyzed, the lower and upper limits were not quantifiable.
|
SECONDARY outcome
Timeframe: 1 month post-vaccination (M1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seroprotection cut-off for the assay was ≥ 0.15 μg/mL.
Outcome measures
| Measure |
Synflorix I Group
n=141 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=24 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=167 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=36 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=269 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations
|
23.066 μg/mL
Interval 18.806 to 28.291
|
26.006 μg/mL
Interval 15.56 to 43.463
|
27.373 μg/mL
Interval 22.915 to 32.697
|
22.011 μg/mL
Interval 16.288 to 29.745
|
20.985 μg/mL
Interval 17.966 to 24.511
|
SECONDARY outcome
Timeframe: 1 month post-vaccination (M1)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seroprotection cut-off for the assay was ≥ 8.
Outcome measures
| Measure |
Synflorix I Group
n=93 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=12 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=114 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=23 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=1 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers
Anti-Polio 3, M1
|
2354.2 Titers
Interval 1946.1 to 2847.9
|
2233.3 Titers
Interval 1300.9 to 3834.0
|
2647.5 Titers
Interval 2221.5 to 3155.3
|
3576.5 Titers
Interval 2617.3 to 4887.2
|
8192 Titers
As there was only 1 subject analyzed, the lower and upper limits were not quantifiable.
|
|
Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers
Anti-Polio 1, M1
|
1193 Titers
Interval 993.8 to 1432.2
|
1534.2 Titers
Interval 952.0 to 2472.5
|
1058.7 Titers
Interval 870.2 to 1288.0
|
1208.6 Titers
Interval 764.2 to 1911.2
|
4096 Titers
As there was only 1 subject analyzed, the lower and upper limits were not quantifiable.
|
|
Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers
Anti-Polio 2, M1
|
1354.1 Titers
Interval 1115.8 to 1643.3
|
2047.9 Titers
Interval 1246.0 to 3365.9
|
1413.2 Titers
Interval 1174.3 to 1700.7
|
2215.8 Titers
Interval 1544.4 to 3178.9
|
8192 Titers
As there was only 1 subject analyzed, the lower and upper limits were not quantifiable.
|
SECONDARY outcome
Timeframe: 12 month post-vaccination (M12)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seroprotection cut-off for the assay was ≥ 10 mIU/mL.
Outcome measures
| Measure |
Synflorix I Group
n=107 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=16 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=133 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=20 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=19 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
|
219.3 mIU/mL
Interval 164.8 to 291.7
|
147.3 mIU/mL
Interval 62.6 to 346.9
|
231.2 mIU/mL
Interval 179.7 to 297.6
|
139.2 mIU/mL
Interval 74.3 to 260.9
|
535.1 mIU/mL
Interval 277.8 to 1030.6
|
SECONDARY outcome
Timeframe: 12 month post-vaccination (M12)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
The seroprotection cut-off for the assay was ≥ 8.
Outcome measures
| Measure |
Synflorix I Group
n=97 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=13 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=122 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=14 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=9 Participants
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers
Anti-Polio 1, M12
|
208.2 Titers
Interval 164.7 to 263.2
|
150.4 Titers
Interval 87.2 to 259.3
|
234.5 Titers
Interval 189.5 to 290.3
|
220.8 Titers
Interval 92.3 to 528.2
|
335.4 Titers
Interval 146.4 to 768.2
|
|
Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers
Anti-Polio 2, M12
|
311.2 Titers
Interval 241.5 to 401.0
|
212.4 Titers
Interval 100.5 to 449.0
|
310.6 Titers
Interval 256.0 to 376.9
|
400 Titers
Interval 218.6 to 732.1
|
322.7 Titers
Interval 172.9 to 602.3
|
|
Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers
Anti-Polio 3, M12
|
431.3 Titers
Interval 332.4 to 559.5
|
301 Titers
Interval 125.8 to 720.4
|
506.3 Titers
Interval 406.3 to 630.7
|
672.2 Titers
Interval 330.0 to 1369.4
|
203.3 Titers
Interval 63.7 to 649.2
|
SECONDARY outcome
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.
Outcome measures
| Measure |
Synflorix I Group
n=414 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)
Pre
|
43 Swabs
|
53 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)
M1
|
45 Swabs
|
47 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)
M3
|
49 Swabs
|
55 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)
M7
|
42 Swabs
|
50 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)
M12
|
34 Swabs
|
43 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)
Overall
|
111 Swabs
|
115 Swabs
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.
Outcome measures
| Measure |
Synflorix I Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=414 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
Pre
|
13 Swabs
|
15 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
M1
|
19 Swabs
|
22 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
M3
|
21 Swabs
|
27 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
M7
|
19 Swabs
|
21 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
M12
|
19 Swabs
|
18 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
Overall
|
55 Swabs
|
59 Swabs
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Outcome measures
| Measure |
Synflorix I Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=414 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
Pre
|
26 Swabs
|
27 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
M1
|
30 Swabs
|
42 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
M3
|
32 Swabs
|
45 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
M7
|
29 Swabs
|
42 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
M12
|
22 Swabs
|
39 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
Overall
|
82 Swabs
|
111 Swabs
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Outcome measures
| Measure |
Synflorix I Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=414 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Nasopharyngeal Swabs With H. Influenzae
Pre
|
41 Swabs
|
48 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With H. Influenzae
M1
|
39 Swabs
|
56 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With H. Influenzae
M3
|
34 Swabs
|
62 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With H. Influenzae
M7
|
49 Swabs
|
64 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With H. Influenzae
M12
|
57 Swabs
|
46 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With H. Influenzae
Overall
|
124 Swabs
|
160 Swabs
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Outcome measures
| Measure |
Synflorix I Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=414 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae
Pre
|
19 Swabs
|
21 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae
M1
|
20 Swabs
|
30 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae
M3
|
17 Swabs
|
31 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae
M7
|
22 Swabs
|
28 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae
M12
|
22 Swabs
|
19 Swabs
|
—
|
—
|
—
|
|
Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae
Overall
|
61 Swabs
|
86 Swabs
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Outcome measures
| Measure |
Synflorix I Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=414 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs
M1
|
43 Participants
|
56 Participants
|
—
|
—
|
—
|
|
Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs
M3
|
63 Participants
|
76 Participants
|
—
|
—
|
—
|
|
Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs
M7
|
70 Participants
|
73 Participants
|
—
|
—
|
—
|
|
Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs
M12
|
65 Participants
|
70 Participants
|
—
|
—
|
—
|
|
Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs
Overall
|
161 Participants
|
195 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Outcome measures
| Measure |
Synflorix I Group
n=336 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=414 Participants
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.
M12
|
39 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.
M1
|
21 Participants
|
32 Participants
|
—
|
—
|
—
|
|
Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.
M3
|
22 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.
M7
|
37 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.
Overall
|
104 Participants
|
129 Participants
|
—
|
—
|
—
|
Adverse Events
Synflorix I Group
Serious events: 13 serious events
Other events: 153 other events
Deaths: 0 deaths
Synflorix II Group
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Synflorix PRE Group
Serious events: 13 serious events
Other events: 154 other events
Deaths: 0 deaths
Synflorix POST Group
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Mencevax + Infanrix Hexa Group
Serious events: 30 serious events
Other events: 290 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synflorix I Group
n=178 participants at risk
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 participants at risk
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=172 participants at risk
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 participants at risk
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=336 participants at risk
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Infections and infestations
Concussion
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.2%
2/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.89%
3/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
2/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.60%
2/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.7%
1/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.58%
1/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.7%
1/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.58%
1/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.58%
1/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.58%
1/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Pharyngeal injury
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.7%
1/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.7%
1/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.7%
1/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.58%
1/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Nervous system disorders
Febrile convulsion
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.60%
2/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Pyrexia
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Reproductive system and breast disorders
Testicular retraction
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.58%
1/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.58%
1/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Gastroenteritis
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.7%
1/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.2%
2/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.7%
1/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.2%
4/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Laryngitis
|
1.1%
2/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.7%
1/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.58%
1/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.2%
4/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.2%
2/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.60%
2/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.7%
1/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.89%
3/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Viral infection
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.7%
1/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.2%
4/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.2%
4/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.7%
1/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Nasopharyngitis
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.60%
2/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Otitis media
|
0.56%
1/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.7%
1/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Vulvitis
|
0.00%
0/178 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/37 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.30%
1/336 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
Other adverse events
| Measure |
Synflorix I Group
n=178 participants at risk
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
|
Synflorix II Group
n=27 participants at risk
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
|
Synflorix PRE Group
n=172 participants at risk
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Synflorix POST Group
n=37 participants at risk
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
|
Mencevax + Infanrix Hexa Group
n=336 participants at risk
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
|
|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
1.7%
3/178 • Number of events 3 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.2%
2/172 • Number of events 2 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
5.4%
2/37 • Number of events 2 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
3.6%
12/336 • Number of events 12 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.4%
47/178 • Number of events 47 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
29.6%
8/27 • Number of events 8 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
26.7%
46/172 • Number of events 46 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
27.0%
10/37 • Number of events 10 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
26.2%
88/336 • Number of events 88 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
50.0%
89/178 • Number of events 89 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
33.3%
9/27 • Number of events 9 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
43.0%
74/172 • Number of events 74 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
32.4%
12/37 • Number of events 12 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
43.5%
146/336 • Number of events 146 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Psychiatric disorders
Irritability
|
48.3%
86/178 • Number of events 86 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
63.0%
17/27 • Number of events 17 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
61.0%
105/172 • Number of events 105 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
51.4%
19/37 • Number of events 19 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
43.8%
147/336 • Number of events 147 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
2/178 • Number of events 2 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
11.1%
3/27 • Number of events 3 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.3%
4/172 • Number of events 4 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.7%
1/37 • Number of events 1 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.89%
3/336 • Number of events 3 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Pain
|
30.3%
54/178 • Number of events 54 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
37.0%
10/27 • Number of events 10 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
45.9%
79/172 • Number of events 79 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
51.4%
19/37 • Number of events 19 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
33.9%
114/336 • Number of events 114 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Pyrexia
|
36.0%
64/178 • Number of events 64 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
51.9%
14/27 • Number of events 14 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
58.1%
100/172 • Number of events 100 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
43.2%
16/37 • Number of events 16 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
43.5%
146/336 • Number of events 147 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Nervous system disorders
Somnolence
|
51.1%
91/178 • Number of events 91 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
40.7%
11/27 • Number of events 11 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
48.8%
84/172 • Number of events 84 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
48.6%
18/37 • Number of events 18 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
43.5%
146/336 • Number of events 146 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Swelling
|
29.2%
52/178 • Number of events 52 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
29.6%
8/27 • Number of events 8 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
29.1%
50/172 • Number of events 50 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
35.1%
13/37 • Number of events 13 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
21.1%
71/336 • Number of events 71 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Viral infection
|
1.1%
2/178 • Number of events 2 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/27 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/172 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
5.4%
2/37 • Number of events 2 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
1.5%
5/336 • Number of events 5 • Solicited and unsolicited symptoms: during the 31-day (Days 0-30) follow-up periods after vaccination; SAEs: during the entire study period (from Month 0 up to Month 12).
|
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