Trial Outcomes & Findings for Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants (NCT NCT00390910)
NCT ID: NCT00390910
Last Updated: 2018-12-17
Results Overview
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
286 participants
Primary outcome timeframe
Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Results posted on
2018-12-17
Participant Flow
For each subject the study duration was approximately 5 months for the active phase (Month 0 untill one month after last vaccination) and 10 months, including the 5 months extended safety follow-up.
During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Synflorix™ + Infanrix™ Hexa Group I
Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
|
Synflorix™ + Infanrix™ Hexa Group II
Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
|
Synflorix™ + Infanrix™ Hexa Group III
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
87
|
149
|
|
Overall Study
COMPLETED
|
48
|
83
|
139
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
10
|
Reasons for withdrawal
| Measure |
Synflorix™ + Infanrix™ Hexa Group I
Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
|
Synflorix™ + Infanrix™ Hexa Group II
Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
|
Synflorix™ + Infanrix™ Hexa Group III
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
|
Overall Study
Migrated/moved from study area
|
0
|
0
|
3
|
Baseline Characteristics
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
Baseline characteristics by cohort
| Measure |
Synflorix™ + Infanrix™ Hexa Group I
n=50 Participants
Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
|
Synflorix™ + Infanrix™ Hexa Group II
n=87 Participants
Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
|
Synflorix™ + Infanrix™ Hexa Group III
n=149 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.0 Weeks
STANDARD_DEVIATION 3.2 • n=93 Participants
|
9.5 Weeks
STANDARD_DEVIATION 1.45 • n=4 Participants
|
9.3 Weeks
STANDARD_DEVIATION 1.45 • n=27 Participants
|
9.66 Weeks
STANDARD_DEVIATION 1.97 • n=483 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
121 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
165 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Etnicity · White - Caucasian/ European heritage
|
36 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
253 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Etnicity · African heritage/ African american
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Etnicity · American Indian or Alaskan native
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Etnicity · Asian - south east Asian heritage
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Etnicity · White - Arabic/ north African heritage
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Etnicity · Other (unspecified)
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in. The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=146 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=135 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
Fever > 39.0°C, post Dose 1
|
5 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
Fever > 39.0°C, post Dose 2
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
Fever > 39.0°C, post Dose 3
|
3 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in. The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").
Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (\>) 30 millimeters (mm). "Any" was defined as incidence of the specified symptom regardless of intensity.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=146 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=135 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 pain, Post Dose 3
|
6 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any pain, Post Dose 1
|
58 Participants
|
40 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 pain, Post Dose 1
|
6 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any redness, Post Dose 1
|
67 Participants
|
39 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 redness, Post Dose 1
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any swelling, Post Dose 1
|
67 Participants
|
30 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 swelling, Post Dose 1
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any pain, Post Dose 2
|
39 Participants
|
39 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 pain, Post Dose 2
|
1 Participants
|
9 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any redness, Post Dose 2
|
72 Participants
|
41 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 redness, Post Dose 2
|
7 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any swelling, Post Dose 2
|
60 Participants
|
30 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 swelling, Post Dose 2
|
4 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any pain, Post Dose 3
|
42 Participants
|
30 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any redness, Post Dose 3
|
66 Participants
|
33 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 redness, Post Dose 3
|
9 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any swelling, Post Dose 3
|
58 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 swelling, Post Dose 3
|
6 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in. The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").
Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=146 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=135 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 drowsiness, Post Dose 1
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any drowsiness, Post Dose 1
|
53 Participants
|
44 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any fever(rectally), Post Dose 1
|
38 Participants
|
41 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 fever(rectally), Post Dose 1
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any irritability, Post Dose 1
|
73 Participants
|
53 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 irritability, Post Dose 1
|
9 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any loss of appetite, Post Dose 1
|
36 Participants
|
33 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 loss of appetite, Post Dose 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any drowsiness, Post Dose 2
|
34 Participants
|
32 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 drowsiness, Post Dose 2
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any fever(rectally), Post Dose 2
|
34 Participants
|
40 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 fever(rectally), Post Dose 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any irritability, Post Dose 2
|
53 Participants
|
51 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 irritability, Post Dose 2
|
2 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any loss of appetite, Post Dose 2
|
23 Participants
|
35 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 loss of appetite, Post Dose 2
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any drowsiness, Post Dose 3
|
22 Participants
|
18 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 drowsiness, Post Dose 3
|
1 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any fever(rectally), Post Dose 3
|
25 Participants
|
16 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 fever(rectally), Post Dose 3
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any irritability, Post Dose 3
|
44 Participants
|
40 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 irritability, Post Dose 3
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Any loss of appetite, Post Dose 3
|
22 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Grade 3 loss of appetite, Post Dose 3
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=149 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=137 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
58 Participants
|
43 Participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=149 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=137 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
13 Participants
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants "Pooled Group I + II") and Full term group (i.e. "Synflorix™ + Infanrix™ Hexa Group III").
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=149 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=137 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
19 Participants
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 0.20 microgram per mililiter (μg/ mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=42 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=82 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=132 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-1
|
41 Participants
|
82 Participants
|
129 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-4
|
40 Participants
|
81 Participants
|
130 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-5
|
42 Participants
|
82 Participants
|
129 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-6B
|
38 Participants
|
78 Participants
|
123 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-7F
|
41 Participants
|
82 Participants
|
131 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-9V
|
40 Participants
|
82 Participants
|
132 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-14
|
41 Participants
|
82 Participants
|
132 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-18C
|
41 Participants
|
81 Participants
|
130 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-19F
|
42 Participants
|
82 Participants
|
132 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Anti-23F
|
39 Participants
|
79 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the ATP cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 0.05 microgram per mililiter (μg/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=42 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=82 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=132 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-1
|
42 Participants
|
82 Participants
|
130 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-4
|
41 Participants
|
82 Participants
|
130 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-5
|
42 Participants
|
82 Participants
|
129 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-6B
|
40 Participants
|
81 Participants
|
131 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-7F
|
41 Participants
|
82 Participants
|
131 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-9V
|
41 Participants
|
82 Participants
|
132 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-14
|
41 Participants
|
82 Participants
|
132 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-18C
|
41 Participants
|
81 Participants
|
131 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-19F
|
42 Participants
|
82 Participants
|
132 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Anti-23F
|
39 Participants
|
81 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=42 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=82 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=132 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-1
|
0.97 μg/mL
Interval 0.75 to 1.26
|
1.1 μg/mL
Interval 0.93 to 1.3
|
1.35 μg/mL
Interval 1.18 to 1.55
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-4
|
1.53 μg/mL
Interval 1.19 to 1.98
|
1.88 μg/mL
Interval 1.61 to 2.2
|
2.42 μg/mL
Interval 2.13 to 2.74
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-5
|
1.45 μg/mL
Interval 1.13 to 1.86
|
1.93 μg/mL
Interval 1.65 to 2.25
|
2.31 μg/mL
Interval 2.0 to 2.66
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-6B
|
0.85 μg/mL
Interval 0.61 to 1.19
|
1.11 μg/mL
Interval 0.89 to 1.37
|
1.18 μg/mL
Interval 1.0 to 1.39
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-7F
|
1.87 μg/mL
Interval 1.47 to 2.39
|
2.37 μg/mL
Interval 2.07 to 2.73
|
2.69 μg/mL
Interval 2.39 to 3.03
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-9V
|
1.43 μg/mL
Interval 1.17 to 1.74
|
1.69 μg/mL
Interval 1.44 to 1.99
|
2.41 μg/mL
Interval 2.13 to 2.73
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-14
|
3.52 μg/mL
Interval 2.81 to 4.42
|
3.28 μg/mL
Interval 2.77 to 3.89
|
3.71 μg/mL
Interval 3.21 to 4.3
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-18C
|
3.28 μg/mL
Interval 2.51 to 4.29
|
4.86 μg/mL
Interval 3.92 to 6.02
|
5.22 μg/mL
Interval 4.27 to 6.38
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-19F
|
3.6 μg/mL
Interval 2.83 to 4.57
|
4.8 μg/mL
Interval 4.15 to 5.55
|
4.56 μg/mL
Interval 3.95 to 5.26
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Anti-23F
|
1.05 μg/mL
Interval 0.74 to 1.49
|
1.33 μg/mL
Interval 1.07 to 1.65
|
1.54 μg/mL
Interval 1.28 to 1.85
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 8
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=36 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=74 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=113 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-1
|
20 Participants
|
49 Participants
|
80 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-4
|
36 Participants
|
72 Participants
|
110 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-5
|
29 Participants
|
69 Participants
|
104 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-6B
|
30 Participants
|
59 Participants
|
85 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-7F
|
36 Participants
|
74 Participants
|
113 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-9V
|
36 Participants
|
72 Participants
|
103 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-14
|
36 Participants
|
73 Participants
|
110 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-18C
|
34 Participants
|
65 Participants
|
99 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-19F
|
31 Participants
|
71 Participants
|
105 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Opsono-23F
|
35 Participants
|
70 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=36 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=74 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=113 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-1
|
23 Titers
Interval 13.0 to 40.6
|
30.3 Titers
Interval 20.5 to 44.8
|
46.3 Titers
Interval 33.4 to 64.1
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-4
|
644.1 Titers
Interval 474.6 to 874.0
|
500.9 Titers
Interval 384.5 to 652.5
|
543.5 Titers
Interval 450.6 to 655.5
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-5
|
45.2 Titers
Interval 27.7 to 73.8
|
70.8 Titers
Interval 52.3 to 95.7
|
94.8 Titers
Interval 75.7 to 118.7
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-6B
|
278.3 Titers
Interval 125.5 to 617.3
|
305.1 Titers
Interval 180.1 to 516.9
|
268.2 Titers
Interval 167.5 to 429.4
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-7F
|
4086.3 Titers
Interval 2834.3 to 5891.3
|
3047.3 Titers
Interval 2422.2 to 3833.7
|
2395.2 Titers
Interval 1973.2 to 2907.5
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-9V
|
930.5 Titers
Interval 603.1 to 1435.6
|
837.9 Titers
Interval 642.7 to 1092.3
|
1144.8 Titers
Interval 922.3 to 1421.0
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-14
|
775.4 Titers
Interval 539.0 to 1115.5
|
901.6 Titers
Interval 699.8 to 1161.6
|
644.6 Titers
Interval 514.9 to 807.0
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-18C
|
262.5 Titers
Interval 159.4 to 432.4
|
321.5 Titers
Interval 220.9 to 467.7
|
251 Titers
Interval 189.0 to 333.4
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-19F
|
104.2 Titers
Interval 61.5 to 176.5
|
201.1 Titers
Interval 149.7 to 270.1
|
182.7 Titers
Interval 139.2 to 239.7
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Opsono-23F
|
1659.4 Titers
Interval 975.1 to 2824.0
|
1147.2 Titers
Interval 843.0 to 1561.2
|
1558.8 Titers
Interval 1302.6 to 1865.3
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=42 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=81 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=131 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
Anti-6A
|
32 Participants
|
68 Participants
|
114 Participants
|
|
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
Anti-19A
|
26 Participants
|
72 Participants
|
120 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=42 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=81 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=131 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Anti-6A
|
0.14 μg/mL
Interval 0.09 to 0.2
|
0.21 μg/mL
Interval 0.15 to 0.28
|
0.2 μg/mL
Interval 0.16 to 0.25
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Anti-19A
|
0.08 μg/mL
Interval 0.06 to 0.11
|
0.21 μg/mL
Interval 0.16 to 0.28
|
0.26 μg/mL
Interval 0.21 to 0.32
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 8.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=33 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=69 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=105 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
Opsono-6A
|
25 Participants
|
54 Participants
|
58 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
Opsono-19A
|
2 Participants
|
10 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seropositivity status was defined as opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=33 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=69 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=105 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Opsono-6A
|
114.5 Titers
Interval 52.8 to 248.5
|
157.3 Titers
Interval 95.8 to 258.4
|
49.5 Titers
Interval 31.8 to 76.9
|
|
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Opsono-19A
|
4.5 Titers
Interval 3.8 to 5.4
|
7.1 Titers
Interval 4.9 to 10.1
|
7 Titers
Interval 5.4 to 9.2
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=42 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=82 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=130 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off
|
42 Participants
|
82 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seropositivity status was defined as anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=42 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=82 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=130 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
|
1688.6 EL.U/mL
Interval 1320.1 to 2159.8
|
1415.4 EL.U/mL
Interval 1167.1 to 1716.5
|
1496.8 EL.U/mL
Interval 1283.4 to 1745.8
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=18 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=41 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=61 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off
Anti-diphtheria
|
18 Participants
|
41 Participants
|
61 Participants
|
|
Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off
Anti-tetanus
|
18 Participants
|
41 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroprotection status was defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=18 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=41 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=61 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off
Anti-diphtheria
|
2.495 IU/mL
Interval 1.664 to 3.741
|
3.23 IU/mL
Interval 2.628 to 3.969
|
3.077 IU/mL
Interval 2.481 to 3.817
|
|
Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off
Anti-tetanus
|
7.745 IU/mL
Interval 6.284 to 9.545
|
8.617 IU/mL
Interval 7.216 to 10.29
|
7.695 IU/mL
Interval 6.838 to 8.66
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 0.15 microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=18 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=41 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=63 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
|
18 Participants
|
41 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 1.0 microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=18 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=41 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=63 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
|
16 Participants
|
38 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroprotection status was defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=18 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=41 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=63 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off
|
4.031 μg/mL
Interval 2.261 to 7.184
|
5.804 μg/mL
Interval 4.12 to 8.178
|
7.952 μg/mL
Interval 5.839 to 10.831
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 5 ELISA unit per milliliter (EL.U/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=18 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=41 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=61 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off
Anti-PT
|
18 Participants
|
41 Participants
|
61 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off
Anti-FHA
|
18 Participants
|
41 Participants
|
61 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off
Anti-PRN
|
17 Participants
|
40 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seropositivity status was defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=18 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=41 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=61 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PT
|
41.9 EL.U/mL
Interval 27.6 to 63.7
|
37.9 EL.U/mL
Interval 30.7 to 46.7
|
47.3 EL.U/mL
Interval 40.2 to 55.7
|
|
Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-FHA
|
188.6 EL.U/mL
Interval 133.4 to 266.6
|
169 EL.U/mL
Interval 139.6 to 204.7
|
163.1 EL.U/mL
Interval 138.3 to 192.3
|
|
Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PRN
|
127.6 EL.U/mL
Interval 81.5 to 199.6
|
109.1 EL.U/mL
Interval 85.7 to 139.0
|
119.1 EL.U/mL
Interval 101.1 to 140.4
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 10 milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=8 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=26 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=12 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off.
|
8 Participants
|
26 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroprotection status was defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=8 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=26 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=12 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
|
431.9 mIU/mL
Interval 240.7 to 775.2
|
356 mIU/mL
Interval 221.1 to 573.4
|
462.9 mIU/mL
Interval 221.1 to 969.1
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The cut-off for the assay was ≥ 8.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=12 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=22 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=29 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres
Anti-Polio 1
|
12 Participants
|
22 Participants
|
29 Participants
|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres
Anti-Polio 2
|
12 Participants
|
22 Participants
|
29 Participants
|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres
Anti-Polio 3
|
10 Participants
|
21 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroprotection status was defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=12 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=22 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=29 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off
Anti-Polio 1
|
271.3 Titers
Interval 132.9 to 554.0
|
189.5 Titers
Interval 109.9 to 326.8
|
230.1 Titers
Interval 166.0 to 319.0
|
|
Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off
Anti-Polio 2
|
341.7 Titers
Interval 214.0 to 545.6
|
319 Titers
Interval 172.5 to 589.8
|
194.4 Titers
Interval 121.7 to 310.7
|
|
Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off
Anti-Polio 3
|
248.4 Titers
Interval 67.9 to 908.7
|
344.7 Titers
Interval 192.2 to 618.3
|
384.8 Titers
Interval 245.3 to 603.6
|
SECONDARY outcome
Timeframe: One month after the 3rd vaccine dose (Month 5)Population: The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Vaccine response to PT, FHA and PRN was defined as appearance of antibodies in subjects who are initially seronegative (S-), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+). For the SYNFLORIX™ + INFANRIX™ HEXA GROUP I, no subjects presented initial seropositivity for PT and PRN antigens.
Outcome measures
| Measure |
Synflorix™ + Infanrix™ Hexa Group III
n=18 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
Pooled Group I + II
n=34 Participants
Pooled group consists of very preterm infants and mild preterm infants (Synflorix™ + Infanrix™ hexa Group I and Synflorix™ + Infanrix™ hexa Group II).
|
Synflorix™ + Infanrix™ Hexa Group III
n=45 Participants
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PRN, S-
|
17 Participants
|
34 Participants
|
45 Participants
|
|
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PT, S-
|
18 Participants
|
27 Participants
|
45 Participants
|
|
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PT, S+
|
0 Participants
|
8 Participants
|
12 Participants
|
|
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-FHA, S-
|
15 Participants
|
22 Participants
|
18 Participants
|
|
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-FHA, S+
|
3 Participants
|
17 Participants
|
41 Participants
|
|
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PRN, S+
|
0 Participants
|
4 Participants
|
12 Participants
|
Adverse Events
Synflorix™ + Infanrix™ Hexa Group I
Serious events: 17 serious events
Other events: 42 other events
Deaths: 1 deaths
Synflorix™ + Infanrix™ Hexa Group II
Serious events: 11 serious events
Other events: 76 other events
Deaths: 0 deaths
Synflorix™ + Infanrix™ Hexa Group III
Serious events: 19 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synflorix™ + Infanrix™ Hexa Group I
n=50 participants at risk
Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
|
Synflorix™ + Infanrix™ Hexa Group II
n=87 participants at risk
Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
|
Synflorix™ + Infanrix™ Hexa Group III
n=149 participants at risk
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
General disorders
Irritability
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.3%
2/149 • Number of events 2 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Bronchiolitis
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
2.0%
3/149 • Number of events 3 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Bronchopneumonia
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Ear infection
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Gastroenteritis
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
2.0%
3/149 • Number of events 3 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.3%
2/149 • Number of events 2 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Otitis media
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Pharyngotonsillitis
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Pneumonia
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Pyelonephritis acute
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.3%
2/149 • Number of events 2 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Tracheitis
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.3%
2/149 • Number of events 2 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Viral infection
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Nervous system disorders
Subdural hygroma
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
2.3%
2/87 • Number of events 2 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/87 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.67%
1/149 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
1.1%
1/87 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
2.3%
2/87 • Number of events 2 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
0.00%
0/149 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
Other adverse events
| Measure |
Synflorix™ + Infanrix™ Hexa Group I
n=50 participants at risk
Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
|
Synflorix™ + Infanrix™ Hexa Group II
n=87 participants at risk
Mild preterm infants born after a gestation period of 31-36 weeks (217-258 days)
|
Synflorix™ + Infanrix™ Hexa Group III
n=149 participants at risk
Infants born after a full-term gestation period of more than 36 weeks (more than 258 days)
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.0%
19/50 • Number of events 30 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
52.9%
46/87 • Number of events 64 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
34.2%
51/149 • Number of events 81 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
48.0%
24/50 • Number of events 32 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
56.3%
49/87 • Number of events 81 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
68.5%
102/149 • Number of events 205 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
General disorders
Injection site nodule
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
4.6%
4/87 • Number of events 4 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
6.7%
10/149 • Number of events 14 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Psychiatric disorders
Irritability
|
44.0%
22/50 • Number of events 38 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
60.9%
53/87 • Number of events 106 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
67.1%
100/149 • Number of events 171 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
General disorders
Pain
|
48.0%
24/50 • Number of events 34 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
47.1%
41/87 • Number of events 75 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
56.4%
84/149 • Number of events 139 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
General disorders
Pyrexia
|
44.0%
22/50 • Number of events 29 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
51.7%
45/87 • Number of events 70 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
47.7%
71/149 • Number of events 106 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Nervous system disorders
Somnolence
|
40.0%
20/50 • Number of events 30 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
50.6%
44/87 • Number of events 64 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
43.6%
65/149 • Number of events 109 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
General disorders
Swelling
|
40.0%
20/50 • Number of events 27 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
40.2%
35/87 • Number of events 57 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
65.8%
98/149 • Number of events 185 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
10.3%
9/87 • Number of events 9 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
6.7%
10/149 • Number of events 12 • Solicited local and general symptoms: during the 4-day post vaccination; Unsolicited AEs: during the 31-day post vaccination; SAEs: during the whole study period (Month 0 - Month 10, including the 5 months extended safety follow-up).
|
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