Trial Outcomes & Findings for Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease (NCT NCT00861380)
NCT ID: NCT00861380
Last Updated: 2020-12-17
Results Overview
The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41188 participants
Primary outcome timeframe
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
Results posted on
2020-12-17
Participant Flow
This study also served as basis for conducting a long-term evaluation of the impact of vaccination with GSK Biologicals' 10Pn-PD-DiT vaccine. Subjects of the 10PN-PD-DIT-053 (112595) study (NCT00839254-EUDRACT:2008-006551-51) contributed to the objectives of this study.
41188 subjects were enrolled in the study, 7 subjects didn't receive any vaccination, 41181 subjects started the study. Total population assessed for combined analyses performed on both studies included 45977 subjects, see details in groups description.
Participant milestones
| Measure |
10Pn3+1-6W-6M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
10Pn2+1-6W-6M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
Ctrl-6W-6M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
10Pn7-11M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Ctrl7-11M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
10Pn12-18M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Ctrl12-18M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8427
|
9112
|
8872
|
3689
|
1812
|
6249
|
3020
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8427
|
9112
|
8872
|
3689
|
1812
|
6249
|
3020
|
Reasons for withdrawal
| Measure |
10Pn3+1-6W-6M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
10Pn2+1-6W-6M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
Ctrl-6W-6M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
10Pn7-11M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Ctrl7-11M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
10Pn12-18M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Ctrl12-18M/043 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal Information not recorded
|
8427
|
9112
|
8872
|
3689
|
1812
|
6249
|
3020
|
Baseline Characteristics
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
Baseline characteristics by cohort
| Measure |
10Pn3+1-6W-6M/043 Group
n=8427 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
10Pn2+1-6W-6M/043 Group
n=9112 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
Ctrl-6W-6M/043 Group
n=8872 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
10Pn7-11M/043 Group
n=3689 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Ctrl7-11M/043 Group
n=1812 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
10Pn12-18M/043 Group
n=6249 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Ctrl12-18M/043 Group
n=3020 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Total
n=41181 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
8427 Participants
n=5 Participants
|
9112 Participants
n=7 Participants
|
8872 Participants
n=5 Participants
|
3689 Participants
n=4 Participants
|
1812 Participants
n=21 Participants
|
6249 Participants
n=10 Participants
|
3020 Participants
n=115 Participants
|
41181 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
4239 Participants
n=5 Participants
|
4399 Participants
n=7 Participants
|
4351 Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
NA Participants
n=10 Participants
|
NA Participants
n=115 Participants
|
NA Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4188 Participants
n=5 Participants
|
4713 Participants
n=7 Participants
|
4521 Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
NA Participants
n=10 Participants
|
NA Participants
n=115 Participants
|
NA Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.
The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10273 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.564 Participants per 1000 person-years
Interval 0.291 to 0.984
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.
The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10054 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.564 Participants per 1000 person-years
Interval 0.291 to 0.984
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log- likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10273 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Other bacteria
|
0.093 Participants per 1000 person-years
Interval 0.011 to 0.336
|
0.188 Participants per 1000 person-years
Interval 0.051 to 0.481
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Neisseria meningitidis
|
0.093 Participants per 1000 person-years
Interval 0.011 to 0.336
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Streptococcus pyogenes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.094 Participants per 1000 person-years
Interval 0.011 to 0.339
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Moraxella catarrhalis
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Culture confirmed ID
|
0.093 Participants per 1000 person-years
Interval 0.011 to 0.336
|
0.845 Participants per 1000 person-years
Interval 0.501 to 1.336
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Pneumococcal invasive disease (IPD)
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.657 Participants per 1000 person-years
Interval 0.359 to 1.103
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 4
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 6B
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.235 Participants per 1000 person-years
Interval 0.076 to 0.548
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 7F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 14
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.188 Participants per 1000 person-years
Interval 0.051 to 0.481
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 18C
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 19F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 23F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Cross-reactive serotypes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.094 Participants per 1000 person-years
Interval 0.011 to 0.339
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 6A
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 19A
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Other pneumococcal serotypes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 3
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 15C
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
H. influenzae ID
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Non-typeable (NTHI)
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log- likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10054 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Culture confirmed ID
|
0.194 Participants per 1000 person-years
Interval 0.053 to 0.496
|
0.845 Participants per 1000 person-years
Interval 0.501 to 1.336
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Pneumococcal invasive disease (IPD)
|
0.097 Participants per 1000 person-years
Interval 0.012 to 0.35
|
0.657 Participants per 1000 person-years
Interval 0.359 to 1.103
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Vaccine serotypes (vaccine type-IPD)
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.564 Participants per 1000 person-years
Interval 0.291 to 0.984
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 4
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 6B
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.235 Participants per 1000 person-years
Interval 0.076 to 0.548
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 7F
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 14
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.188 Participants per 1000 person-years
Interval 0.051 to 0.481
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 18C
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 19F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 23F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Cross-reactive serotypes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.094 Participants per 1000 person-years
Interval 0.011 to 0.339
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 6A
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 19A
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Other pneumococcal serotypes
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 3
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Serotype 15C
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
H. influenzae ID
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Non-typeable (NTHI)
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Other bacteria
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.188 Participants per 1000 person-years
Interval 0.051 to 0.481
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Neisseria meningitidis
|
0.048 Participants per 1000 person-years
Interval 0.001 to 0.27
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Streptococcus pyogenes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.094 Participants per 1000 person-years
Interval 0.001 to 0.339
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period)
Moraxella catarrhalis
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.047 Participants per 1000 person-years
Interval 0.001 to 0.262
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log- likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=3880 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=1908 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Culture confirmed ID
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.446 Participants per 1000 person-years
Interval 0.054 to 1.612
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Pneumococcal invasive disease (IPD)
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.446 Participants per 1000 person-years
Interval 0.054 to 1.612
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Vaccine serotypes (vaccine type-IPD)
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.446 Participants per 1000 person-years
Interval 0.054 to 1.612
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 4
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 6B
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 7F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.223 Participants per 1000 person-years
Interval 0.006 to 1.243
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 14
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.223 Participants per 1000 person-years
Interval 0.006 to 1.243
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 18C
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 19F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 23F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Cross-reactive serotypes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 6A
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 19A
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Other pneumococcal serotypes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 3
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Serotype 15C
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
H. influenzae ID
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Non-typeable (NTHI)
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Other bacteria
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log- likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=6535 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=3126 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Culture confirmed ID
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.674 Participants per 1000 person-years
Interval 0.219 to 1.572
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Pneumococcal invasive disease (IPD)
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.674 Participants per 1000 person-years
Interval 0.219 to 1.572
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Vaccine serotypes (vaccine type-IPD)
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.404 Participants per 1000 person-years
Interval 0.083 to 1.181
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 4
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.135 Participants per 1000 person-years
Interval 0.003 to 0.751
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 6B
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.135 Participants per 1000 person-years
Interval 0.003 to 0.751
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 7F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 14
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 18C
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 19F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.135 Participants per 1000 person-years
Interval 0.0003 to 0.751
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 23F
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Cross-reactive serotypes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 6A
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 19A
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Other pneumococcal serotypes
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.269 Participants per 1000 person-years
Interval 0.033 to 0.974
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 3
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.135 Participants per 1000 person-years
Interval 0.003 to 0.751
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Serotype 15C
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.135 Participants per 1000 person-years
Interval 0.003 to 0.751
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
H. influenzae ID
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Non-typeable (NTHI)
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Other bacteria
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10273 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in the Prevention of Probable Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
Probable cases of IPD
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.141 Participants per 1000 person-years
Interval 0.029 to 0.412
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Probable Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
Confirmed or probable cases of IPD
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.172
|
0.798 Participants per 1000 person-years
Interval 0.465 to 1.278
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Infant Vaccinated cohort, all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10054 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
Probable cases of IPD
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.179
|
0.141 Participants per 1000 person-years
Interval 0.029 to 0.412
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
Confirmed or probable cases of IPD
|
0.097 Participants per 1000 person-years
Interval 0.012 to 0.35
|
0.798 Participants per 1000 person-years
Interval 0.465 to 1.278
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=3880 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=1908 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Probable cases of IPD
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.823
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule
Confirmed or probable cases of IPD
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.41
|
0.446 Participants per 1000 person-years
Interval 0.054 to 1.612
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)Population: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata. Data were not collected regarding indirect effects.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=6535 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=3126 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Probable cases of IPD
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.497
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Confirmed or probable cases of IPD
|
0.000 Participants per 1000 person-years
Interval 0.0 to 0.24
|
0.674 Participants per 1000 person-years
Interval 0.219 to 1.572
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.
PYAR was calculated: n (=number of subjects with hospital-diagnosed pneumonia) divided by T (=sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10273 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10200 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
|
10.131 Participants per 1000 person-years
Interval 8.804 to 11.601
|
13.854 Participants per 1000 person-years
Interval 12.287 to 15.566
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10054 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10200 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
|
10.155 Participants per 1000 person-years
Interval 8.8 to 11.66
|
13.854 Participants per 1000 person-years
Interval 12.287 to 15.566
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 monthsPopulation: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=3880 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=1907 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination in the 7-11 Months Schedule
|
10.263 Participants per 1000 person-years
Interval 8.242 to 12.63
|
15.752 Participants per 1000 person-years
Interval 12.232 to 19.97
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 monthsPopulation: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=6534 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=3126 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
|
9.322 Participants per 1000 person-years
Interval 7.832 to 11.013
|
11.739 Participants per 1000 person-years
Interval 9.363 to 14.533
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia \[HDP\]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10273 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10200 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With Chest X-ray (CXR) Reading According to WHO Criteria- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
Consolidated pneumonia
|
2.181 Participants per 1000 person-years
Interval 1.591 to 2.919
|
3.965 Participants per 1000 person-years
Interval 3.149 to 4.929
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With Chest X-ray (CXR) Reading According to WHO Criteria- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
Non-consolidated pneumonia
|
2.908 Participants per 1000 person-years
Interval 2.219 to 3.744
|
2.937 Participants per 1000 person-years
Interval 2.241 to 3.781
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With Chest X-ray (CXR) Reading According to WHO Criteria- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
Consolidated or non- consolidated pneumonia
|
5.090 Participants per 1000 person-years
Interval 4.163 to 6.161
|
6.903 Participants per 1000 person-years
Interval 5.81 to 8.141
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia \[HDP\]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10054 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10200 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
Consolidated pneumonia
|
2.273 Participants per 1000 person-years
Interval 1.658 to 3.042
|
3.965 Participants per 1000 person-years
Interval 3.149 to 4.929
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
Non-consolidated pneumonia
|
2.627 Participants per 1000 person-years
Interval 1.962 to 3.445
|
2.937 Participants per 1000 person-years
Interval 2.241 to 3.781
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
Consolidated or non- consolidated pneumonia
|
4.901 Participants per 1000 person-years
Interval 3.974 to 5.978
|
6.903 Participants per 1000 person-years
Interval 5.81 to 8.141
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 monthsPopulation: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia \[HDP\]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=3880 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=1907 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 7-11 Months Schedule
Consolidated pneumonia
|
1.960 Participants per 1000 person-years
Interval 1.142 to 3.139
|
4.401 Participants per 1000 person-years
Interval 2.65 to 6.873
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 7-11 Months Schedule
Non-consolidated pneumonia
|
3.344 Participants per 1000 person-years
Interval 2.24 to 4.803
|
4.865 Participants per 1000 person-years
Interval 3.011 to 7.436
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 7-11 Months Schedule
Consolidated or non- consolidated pneumonia
|
5.305 Participants per 1000 person-years
Interval 3.884 to 7.076
|
9.266 Participants per 1000 person-years
Interval 6.62 to 12.618
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 monthsPopulation: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia \[HDP\]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=6534 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=3126 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 12-18 Months Schedule
Consolidated pneumonia
|
1.824 Participants per 1000 person-years
Interval 1.202 to 2.654
|
3.494 Participants per 1000 person-years
Interval 2.261 to 5.157
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 12-18 Months Schedule
Non-consolidated pneumonia
|
2.837 Participants per 1000 person-years
Interval 2.045 to 3.835
|
2.935 Participants per 1000 person-years
Interval 1.817 to 4.486
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 12-18 Months Schedule
Consolidated or non- consolidated pneumonia
|
4.661 Participants per 1000 person-years
Interval 3.626 to 5.899
|
6.428 Participants per 1000 person-years
Interval 4.706 to 8.574
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.
PYAR was calculated: n (= number of subjects with tympanostomy tube placement\[TTP\]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10273 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10200 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Prevention of All Tympanostomy Tube Placements- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
|
68.735 Participants per 1000 person-years
Interval 65.203 to 72.408
|
79.504 Participants per 1000 person-years
Interval 75.683 to 83.467
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.
PYAR was calculated: n (= number of subjects with tympanostomy tube placement\[TTP\]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10054 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10200 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
|
66.083 Participants per 1000 person-years
Interval 62.55 to 69.764
|
79.504 Participants per 1000 person-years
Interval 75.683 to 83.467
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 monthsPopulation: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.
PYAR was calculated: n (= number of subjects with tympanostomy tube placement\[TTP\]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=3880 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=1907 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 7-11 Months Schedule
|
68.153 Participants per 1000 person-years
Interval 62.769 to 73.876
|
79.920 Participants per 1000 person-years
Interval 71.708 to 88.814
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 monthsPopulation: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.
PYAR was calculated: n (= number of subjects with tympanostomy tube placement\[TTP\]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=6534 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=3126 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
|
56.809 Participants per 1000 person-years
Interval 53.034 to 60.782
|
58.973 Participants per 1000 person-years
Interval 53.48 to 64.877
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.
PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical \[ATC\] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10273 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10200 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Prevention of All Antimicrobial Prescriptions- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
Antimicrobial prescriptions (ATC code J01)
|
1592.585 Participants per 1000 person-years
Interval 1575.411 to 1609.901
|
1706.194 Participants per 1000 person-years
Interval 1688.328 to 1724.202
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Prevention of All Antimicrobial Prescriptions- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course
For otitis media and respiratory infections
|
1451.141 Participants per 1000 person-years
Interval 1434.749 to 1467.674
|
1565.692 Participants per 1000 person-years
Interval 1548.579 to 1582.947
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.
PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical \[ATC\] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10054 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10200 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
Antimicrobial prescriptions (ATC code J01)
|
1552.493 Participants per 1000 person-years
Interval 1535.183 to 1569.95
|
1706.194 Participants per 1000 person-years
Interval 1688.328 to 1724.202
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course
For otitis media and respiratory infections
|
1415.983 Participants per 1000 person-years
Interval 1399.453 to 1432.659
|
1565.692 Participants per 1000 person-years
Interval 1548.579 to 1582.947
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 monthsPopulation: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.
PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical \[ATC\] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=3880 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=1907 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 7-11 Months Schedule
Antimicrobial prescriptions (ATC code J01)
|
1536.618 Participants per 1000 person-years
Interval 1510.637 to 1562.934
|
1649.360 Participants per 1000 person-years
Interval 1611.269 to 1688.124
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 7-11 Months Schedule
For otitis media and respiratory infections
|
1390.856 Participants per 1000 person-years
Interval 1366.143 to 1415.903
|
1499.713 Participants per 1000 person-years
Interval 1463.401 to 1536.698
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 monthsPopulation: The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.
PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical \[ATC\] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=6534 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=3126 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
Antimicrobial prescriptions (ATC code J01)
|
1315.936 Participants per 1000 person-years
Interval 1297.521 to 1334.547
|
1421.774 Participants per 1000 person-years
Interval 1394.28 to 1449.675
|
—
|
—
|
—
|
—
|
—
|
|
Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population)
For otitis media and respiratory infections
|
1177.729 Participants per 1000 person-years
Interval 1160.312 to 1195.343
|
1271.268 Participants per 1000 person-years
Interval 1245.277 to 1297.665
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - mean FU time=24 monthsPopulation: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age.
Antimicrobial susceptibility classification of IPD isolates reported during IPD follow-up with percentages for each serotype for the following categories: S= susceptible; I = intermediate ; R = resistant; N = not available.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=2 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=24 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-4 -Pencillin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6A -Pencillin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Pencillin-I
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Pencillin-R
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Pencillin-S
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-7F -Pencillin-S
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Pencillin-I
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Pencillin-R
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Pencillin-S
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-15C -Pencillin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-18C -Pencillin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19A -Pencillin-I
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Pencillin-I
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Pencillin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-23F -Pencillin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-N -Pencillin-N
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-4 -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6A -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Erythromycin-R
|
—
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-7F -Erythromycin-S
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Erythromycin-R
|
—
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-15C -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-18C -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19A -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Erythromycin-R
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-23F -Erythromycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-N -Erythromycin-N
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-4 -Tetracyclin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6A -Tetracyclin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Tetracyclin-R
|
—
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Tetracyclin-S
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-7F -Tetracyclin-S
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Tetracyclin-S
|
—
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-15C -Tetracyclin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-18C -Tetracyclin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19A -Tetracyclin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Tetracyclin-R
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Tetracyclin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-23F -Tetracyclin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-N -Tetracyclin-N
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-4 -Levoffloxacin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6A -Levoffloxacin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Levoffloxacin-S
|
—
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-7F -Levoffloxacin-S
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Levoffloxacin-S
|
—
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-15C -Levoffloxacin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-18C -Levoffloxacin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19A -Levoffloxacin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Levoffloxacin-S
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-23F -Levoffloxacin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-N -Levoffloxacin-N
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-4 -Ceftriaxone-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6A -Ceftriaxone-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Ceftriaxone-S
|
—
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-7F -Ceftriaxone-S
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Ceftriaxone-I
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Ceftriaxone-S
|
—
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-15C -Ceftriaxone-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-18C -Ceftriaxone-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19A -Ceftriaxone-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Ceftriaxone-S
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-23F -Ceftriaxone-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-N -Ceftriaxone-N
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-4 -Clindamycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6A -Clindamycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Clindamycin-R
|
—
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-6B -Clindamycin-S
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-7F -Clindamycin-S
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Clindamycin-N
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-14 -Clindamycin-S
|
—
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-15C -Clindamycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-18C -Clindamycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19A -Clindamycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Clindamycin-R
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-19F -Clindamycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-23F -Clindamycin-S
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Serotype-N -Clindamycin-N
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months)Population: The analysis was performed in a subset of vaccinated subjects including all vaccinated subjects enrolled in the 10PN-PD-DIT-053 study in the Turku area and those vaccinated subjects enrolled in the 10PN-PD-DIT-043 study in the Turku area who agreed to take part in this assessment.
Analysis of this outcome was performed in the Turku area. The number of subjects reporting at least one LRTI any time after the administration of the first vaccine dose was tabulated.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=243 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=190 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=171 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
n=31 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
n=22 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
n=62 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
n=48 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Lower Respiratory Tract Infections (LRTIs) (in a Subset of Subjects in Turku Area)
|
19 Participants
|
19 Participants
|
19 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months)Population: The analysis was performed in a subset of vaccinated subjects including all vaccinated subjects enrolled in the 10PN-PD-DIT-053 study in the Turku area and those vaccinated subjects enrolled in the 10PN-PD-DIT-043 study in the Turku area who agreed to take part in this assessment.
Analysis of this outcome was performed in the Turku area. The number of subjects reporting at least one URTI any time after the administration of the first vaccine dose was tabulated.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=243 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=190 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=171 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
n=31 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
n=22 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
n=62 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
n=48 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Upper Respiratory Tract Infections (URTIs) (in a Subset of Subjects in Turku Area)
|
158 Participants
|
124 Participants
|
94 Participants
|
14 Participants
|
15 Participants
|
27 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: For Month 0 till the end of the blinded ID Follow-Up, (at least 30 months from study start)An event is defined as 'serious' when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=8427 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=9112 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=8872 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
n=3689 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
n=1812 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
n=6249 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
n=3020 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With SAEs Reported During the Blinded Invasive Disease Phase, of the Study
|
6 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the end of the blinded ID Follow-Up period(at least 30 months from study start) up to the end of 18-month period after study unblindingAn event is defined as 'serious' when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10273 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10054 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
n=3880 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
n=1908 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
n=6535 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
n=3126 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Enrolled and Vaccinated in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 Study With Post-study SAEs Reported Via Passive Surveillance- Subjects Enrolled Aged 6 Weeks to 6 Months and 7 to 18 Months
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months)Population: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10272 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Culture confirmed ID
|
0.046 Participants per 1000 person-years
Interval 0.013 to 0.118
|
0.268 Participants per 1000 person-years
Interval 0.17 to 0.402
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Pneumococcal invasive disease (IPD)
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
0.210 Participants per 1000 person-years
Interval 0.124 to 0.331
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Vaccine serotypes (vaccine type-IPD)
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.140 Participants per 1000 person-years
Interval 0.072 to 0.244
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 4
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 6B
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.058 Participants per 1000 person-years
Interval 0.019 to 0.136
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 7F
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 14
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.047 Participants per 1000 person-years
Interval 0.013 to 0.119
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 18C
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 19F
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 23F
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Cross-reactive serotypes
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.064
|
0.047 Participants per 1000 person-years
Interval 0.013 to 0.119
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 6A
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 19A
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.064
|
0.035 Participants per 1000 person-years
Interval 0.007 to 0.102
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Other pneumococcal serotypes
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.064
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 3
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.064
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 12F
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Serotype 15C
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
H. influenzae ID
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Non-typeable (NTHI)
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Other bacteria
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
0.058 Participants per 1000 person-years
Interval 0.019 to 0.136
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Neisseria meningitidis
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Streptococcus pyogenes
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period
Moraxella catarrhalis
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months)Population: The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Outcome measures
| Measure |
10Pn3+1-6W-6M/043+053 Group
n=10053 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008- 006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
n=10201 Participants
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl-6W-6M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
10Pn7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl7-11M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
10Pn12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PDDIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PDDiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
Ctrl12-18M/043+053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|---|---|---|---|---|---|---|---|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Non-typeable (NTHI)
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.066
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Other bacteria
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.066
|
0.058 Participants per 1000 person-years
Interval 0.019 to 0.136
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Neisseria meningitidis
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.066
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Streptococcus pyogenes
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Moraxella catarrhalis
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 19F
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 23F
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Culture confirmed ID
|
0.047 Participants per 1000 person-years
Interval 0.013 to 0.122
|
0.268 Participants per 1000 person-years
Interval 0.17 to 0.402
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Pneumococcal invasive disease (IPD)
|
0.024 Participants per 1000 person-years
Interval 0.003 to 0.086
|
0.21 Participants per 1000 person-years
Interval 0.124 to 0.331
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Vaccine serotypes (vaccine type-IPD)
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.066
|
0.140 Participants per 1000 person-years
Interval 0.072 to 0.244
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 4
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 6B
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.058 Participants per 1000 person-years
Interval 0.019 to 0.136
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 7F
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.066
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 14
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.047 Participants per 1000 person-years
Interval 0.013 to 0.119
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 18C
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Cross-reactive serotypes
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.047 Participants per 1000 person-years
Interval 0.013 to 0.119
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 6A
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 19A
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.035 Participants per 1000 person-years
Interval 0.007 to 0.102
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Other pneumococcal serotypes
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.066
|
0.023 Participants per 1000 person-years
Interval 0.003 to 0.084
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 3
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.066
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 12F
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
Serotype 15C
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.044
|
0.0 Participants per 1000 person-years
Interval 0.0 to 0.043
|
—
|
—
|
—
|
—
|
—
|
|
Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period
H. influenzae ID
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.066
|
0.012 Participants per 1000 person-years
Interval 0.0 to 0.065
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
10Pn3+1-6W-6M/043 Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 4 deaths
10Pn2+1-6W-6M/043 Group
Serious events: 7 serious events
Other events: 0 other events
Deaths: 4 deaths
Ctrl-6W-6M/043 Group
Serious events: 8 serious events
Other events: 0 other events
Deaths: 3 deaths
10Pn7-11M/043 Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Ctrl7-11M/043 Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
10Pn12-18M/043 Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Ctrl12-18M/043 Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
10Pn3+1-6W-6M/043 Group
n=8427 participants at risk
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
10Pn2+1-6W-6M/043 Group
n=9112 participants at risk
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
Ctrl-6W-6M/043 Group
n=8872 participants at risk
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
|
10Pn7-11M/043 Group
n=3689 participants at risk
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Ctrl7-11M/043 Group
n=1812 participants at risk
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
10Pn12-18M/043 Group
n=6249 participants at risk
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
Ctrl12-18M/043 Group
n=3020 participants at risk
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
|
|---|---|---|---|---|---|---|---|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.03%
1/3689 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.02%
1/6249 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Congenital, familial and genetic disorders
Gaucher's disease
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Congenital, familial and genetic disorders
Krabbe's disease
|
0.01%
1/8427 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.03%
1/3020 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.06%
1/1812 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.03%
1/3689 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.03%
1/3020 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.06%
1/1812 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Nervous system disorders
Hypotonic-hyporesponsive episode
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
General disorders
Accidental death
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
General disorders
Death
|
0.01%
1/8427 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
General disorders
Injection site reaction
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
General disorders
Irritability
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
General disorders
Pyrexia
|
0.02%
2/8427 • Number of events 2 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
General disorders
Sudden death
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
General disorders
Sudden infant death syndrome
|
0.01%
1/8427 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.01%
1/8427 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.02%
1/6249 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Gastrointestinal disorders
Vomiting
|
0.01%
1/8427 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Hepatobiliary disorders
Reye's syndrome
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.01%
1/8427 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Infections and infestations
Infection
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Infections and infestations
Parotitis
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/9112 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.01%
1/8872 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.06%
1/1812 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Infections and infestations
Sepsis
|
0.01%
1/8427 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3689 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8427 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/9112 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/8872 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.03%
1/3689 • Number of events 1 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/1812 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/6249 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
0.00%
0/3020 • SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
Solicited and unsolicited AEs were not collected in this study.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER