Trial Outcomes & Findings for Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants. (NCT NCT00609492)

Results Overview

Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

245 participants

Primary outcome timeframe

Within 4-days (Day 0-3) after booster vaccination

Results posted on

2020-01-03

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Participant milestones
Measure	Preterm I Group Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Preterm II Group Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Overall Study STARTED	44	72	129
Overall Study COMPLETED	43	69	122
Overall Study NOT COMPLETED	1	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Preterm I Group Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Preterm II Group Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Overall Study Withdrawal by Subject	0	2	3
Overall Study Lost to Follow-up	1	1	4

Baseline Characteristics

Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preterm I Group n=44 Participants Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Preterm II Group n=72 Participants Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=129 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Total n=245 Participants Total of all reporting groups
Age, Continuous	16.8 Months STANDARD_DEVIATION 0.63 • n=5 Participants	17.2 Months STANDARD_DEVIATION 0.68 • n=7 Participants	16.6 Months STANDARD_DEVIATION 0.73 • n=5 Participants	16.81 Months STANDARD_DEVIATION 0.74 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants	95 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	43 Participants n=7 Participants	79 Participants n=5 Participants	150 Participants n=4 Participants

PRIMARY outcome

Timeframe: Within 4-days (Day 0-3) after booster vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.

Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.

Outcome measures

Outcome measures
Measure	Preterm Group n=112 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=122 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)	8 Subjects	6 Subjects	—

SECONDARY outcome

Timeframe: Within 4-days (Day 0-3) after booster vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.

Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

Outcome measures

Outcome measures
Measure	Preterm Group n=112 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=122 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	47 Subjects	67 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	5 Subjects	4 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	35 Subjects	65 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	3 Subjects	19 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	27 Subjects	55 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	1 Subjects	14 Subjects	—

SECONDARY outcome

Timeframe: Within 4-days (Day 0-3) after booster vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.

Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Preterm Group n=112 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=122 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Drowsiness	1 Subjects	1 Subjects	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Fever	34 Subjects	39 Subjects	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Drowsiness	21 Subjects	33 Subjects	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Fever	0 Subjects	1 Subjects	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Irritability	36 Subjects	49 Subjects	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Irritability	2 Subjects	2 Subjects	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Loss of appetite	26 Subjects	35 Subjects	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Loss of appetite	0 Subjects	1 Subjects	—

SECONDARY outcome

Timeframe: Within 31-days (Day 0-30) after booster vaccination

Population: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects for whom data were available.

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Preterm Group n=116 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=129 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Subjects With Unsolicited Adverse Events (AEs)	17 Subjects	24 Subjects	—

SECONDARY outcome

Timeframe: Throughout the active phase of the study (Month 0 to Month 1)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Preterm Group n=116 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=129 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	0 Subjects	0 Subjects	—

SECONDARY outcome

Timeframe: Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Preterm Group n=116 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=129 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	3 Subjects	1 Subjects	—

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=43 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=69 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=125 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-6B, Post-booster [N=42;66;119]	42 Subjects	65 Subjects	119 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-7F, Pre-booster [N=43;65;123]	42 Subjects	65 Subjects	123 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-7F, Post-booster [N=43;66;118]	43 Subjects	66 Subjects	118 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-1, Pre-booster [N=43;66;121]	39 Subjects	56 Subjects	111 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-1, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-4, Pre-booster [N=43;69;123]	40 Subjects	68 Subjects	120 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-4, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-5, Pre-booster [N=43;68;124]	41 Subjects	66 Subjects	122 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-5, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-6B, Pre-booster [N=43;67;124]	41 Subjects	66 Subjects	119 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-9V, Pre-booster [N=43;69;123]	43 Subjects	69 Subjects	123 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-9V, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-14, Pre-booster [N=43;68;124]	43 Subjects	68 Subjects	121 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-14, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-18C, Pre-booster [N=43;68;125]	43 Subjects	68 Subjects	123 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-18C, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	118 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-19F, Pre-booster [N=43;68;125]	43 Subjects	68 Subjects	125 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-19F, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-23F, Pre-booster [N=43;69;123]	41 Subjects	68 Subjects	122 Subjects
Number of Seropositive Subjects for Anti-pneumococcal Serotypes Anti-23F, Post-booster [N=42;66;119]	41 Subjects	66 Subjects	118 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Outcome measures

Outcome measures
Measure	Preterm Group n=44 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=69 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=125 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-1, Pre-booster [N=43;66;121]	16 Subjects	28 Subjects	53 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-1, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	118 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-4, Pre-booster [N=43;69;123]	23 Subjects	40 Subjects	82 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-4, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-5, Pre-booster [N=43;68;124]	27 Subjects	43 Subjects	105 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-5, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-6B, Pre-booster [N=43;67;124]	28 Subjects	41 Subjects	99 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-6B, Post-booster [N=42;66;119]	42 Subjects	65 Subjects	119 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-7F, Pre-booster [N=43;65;123]	34 Subjects	56 Subjects	115 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-7F, Post-booster [N=43;66;118]	43 Subjects	66 Subjects	118 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-9V, Pre-booster [N=43;69;123]	39 Subjects	59 Subjects	115 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-9V, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-14, Pre-booster [N=43;68;124]	41 Subjects	55 Subjects	105 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-14, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-18C, Pre-booster [N=43;68;125]	36 Subjects	60 Subjects	106 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-18C, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	118 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-19F, Pre-booster [N=43;68;125]	38 Subjects	66 Subjects	120 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-19F, Post-booster [N=43;66;119]	43 Subjects	66 Subjects	119 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-23F, Pre-booster [N=43;69;123]	30 Subjects	45 Subjects	99 Subjects
Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes Anti-23F, Post-booster [N=42;66;119]	41 Subjects	66 Subjects	118 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	Preterm Group n=43 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=69 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=125 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Antibody Concentrations Against Pneumococcal Serotypes Anti-14, Post-booster [N=43;66;119]	4.88 µg/mL Interval 3.42 to 6.98	5.14 µg/mL Interval 4.22 to 6.25	5.98 µg/mL Interval 5.1 to 7.02
Antibody Concentrations Against Pneumococcal Serotypes Anti-1, Pre-booster [N=43;66;121]	0.15 µg/mL Interval 0.11 to 0.2	0.14 µg/mL Interval 0.11 to 0.18	0.17 µg/mL Interval 0.15 to 0.21
Antibody Concentrations Against Pneumococcal Serotypes Anti-1, Post-booster [N=43;66;119]	1.57 µg/mL Interval 1.2 to 2.05	1.74 µg/mL Interval 1.41 to 2.15	1.98 µg/mL Interval 1.66 to 2.37
Antibody Concentrations Against Pneumococcal Serotypes Anti-4, Pre-booster [N=43;69;123]	0.25 µg/mL Interval 0.18 to 0.35	0.24 µg/mL Interval 0.2 to 0.3	0.30 µg/mL Interval 0.25 to 0.35
Antibody Concentrations Against Pneumococcal Serotypes Anti-4, Post-booster [N=43;66;119]	2.98 µg/mL Interval 2.31 to 3.85	3.67 µg/mL Interval 3.07 to 4.39	4.23 µg/mL Interval 3.67 to 4.88
Antibody Concentrations Against Pneumococcal Serotypes Anti-5, Pre-booster [N=43;68;124]	0.24 µg/mL Interval 0.18 to 0.33	0.27 µg/mL Interval 0.21 to 0.34	0.40 µg/mL Interval 0.34 to 0.48
Antibody Concentrations Against Pneumococcal Serotypes Anti-5, Post-booster [N=43;66;119]	1.84 µg/mL Interval 1.43 to 2.38	2.38 µg/mL Interval 1.93 to 2.94	2.58 µg/mL Interval 2.2 to 3.02
Antibody Concentrations Against Pneumococcal Serotypes Anti-6B, Pre-booster [N=43;67;124]	0.28 µg/mL Interval 0.21 to 0.38	0.30 µg/mL Interval 0.23 to 0.37	0.37 µg/mL Interval 0.31 to 0.45
Antibody Concentrations Against Pneumococcal Serotypes Anti-6B, Post-booster [N=42;66;119]	2.44 µg/mL Interval 1.87 to 3.17	2.46 µg/mL Interval 1.97 to 3.06	2.67 µg/mL Interval 2.27 to 3.13
Antibody Concentrations Against Pneumococcal Serotypes Anti-7F, Pre-booster [N=43;65;123]	0.42 µg/mL Interval 0.31 to 0.56	0.46 µg/mL Interval 0.37 to 0.58	0.66 µg/mL Interval 0.57 to 0.77
Antibody Concentrations Against Pneumococcal Serotypes Anti-7F, Post-booster [N=43;66;118]	3.11 µg/mL Interval 2.48 to 3.9	4.16 µg/mL Interval 3.52 to 4.9	3.93 µg/mL Interval 3.45 to 4.47
Antibody Concentrations Against Pneumococcal Serotypes Anti-9V, Pre-booster [N=43;69;123]	0.51 µg/mL Interval 0.39 to 0.67	0.42 µg/mL Interval 0.35 to 0.52	0.59 µg/mL Interval 0.51 to 0.69
Antibody Concentrations Against Pneumococcal Serotypes Anti-9V, Post-booster [N=43;66;119]	2.87 µg/mL Interval 2.23 to 3.7	3.47 µg/mL Interval 2.86 to 4.2	4.17 µg/mL Interval 3.6 to 4.83
Antibody Concentrations Against Pneumococcal Serotypes Anti-14, Pre-booster [N=43;68;124]	0.78 µg/mL Interval 0.54 to 1.11	0.48 µg/mL Interval 0.37 to 0.61	0.68 µg/mL Interval 0.55 to 0.84
Antibody Concentrations Against Pneumococcal Serotypes Anti-18C, Pre-booster [N=43;68;125]	0.58 µg/mL Interval 0.42 to 0.8	0.56 µg/mL Interval 0.45 to 0.7	0.60 µg/mL Interval 0.49 to 0.73
Antibody Concentrations Against Pneumococcal Serotypes Anti-18C, Post-booster [N=43;66;119]	9.51 µg/mL Interval 7.36 to 12.29	13.20 µg/mL Interval 10.97 to 15.89	12.38 µg/mL Interval 10.21 to 15.0
Antibody Concentrations Against Pneumococcal Serotypes Anti-19F, Pre-booster [N=43;68;125]	0.86 µg/mL Interval 0.58 to 1.3	1.07 µg/mL Interval 0.78 to 1.46	1.27 µg/mL Interval 1.02 to 1.59
Antibody Concentrations Against Pneumococcal Serotypes Anti-19F, Post-booster [N=43;66;119]	6.83 µg/mL Interval 5.24 to 8.89	9.78 µg/mL Interval 8.19 to 11.68	9.72 µg/mL Interval 8.38 to 11.29
Antibody Concentrations Against Pneumococcal Serotypes Anti-23F, Pre-booster [N=43;69;123]	0.27 µg/mL Interval 0.2 to 0.36	0.30 µg/mL Interval 0.24 to 0.38	0.42 µg/mL Interval 0.35 to 0.51
Antibody Concentrations Against Pneumococcal Serotypes Anti-23F, Post-booster [N=42;66;119]	2.70 µg/mL Interval 1.91 to 3.81	3.45 µg/mL Interval 2.93 to 4.06	3.30 µg/mL Interval 2.74 to 3.99

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=43 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=67 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=122 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-6A, Pre-booster [N=42;67;122]	34 Subjects	51 Subjects	98 Subjects
Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-6A, Post-booster [N=42;66;118]	41 Subjects	63 Subjects	115 Subjects
Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-19A, Pre-booster [N=43;67;121]	28 Subjects	49 Subjects	95 Subjects
Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-19A, Post-booster [N=42;66;118]	40 Subjects	63 Subjects	113 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	Preterm Group n=43 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=67 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=122 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-6A, Pre-booster [N=42;67;122]	0.12 µg/mL Interval 0.08 to 0.17	0.12 µg/mL Interval 0.09 to 0.16	0.14 µg/mL Interval 0.12 to 0.18
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-6A, Post-booster [N=42;66;118]	0.70 µg/mL Interval 0.47 to 1.05	0.77 µg/mL Interval 0.55 to 1.07	0.79 µg/mL Interval 0.61 to 1.02
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-19A, Pre-booster [N=43;67;121]	0.14 µg/mL Interval 0.08 to 0.24	0.15 µg/mL Interval 0.1 to 0.22	0.16 µg/mL Interval 0.12 to 0.22
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-19A, Post-booster [N=42;66;118]	0.65 µg/mL Interval 0.4 to 1.04	0.93 µg/mL Interval 0.64 to 1.37	1.10 µg/mL Interval 0.82 to 1.47

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=43 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=67 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=123 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) Anti-PD, Pre-booster [N=42;67;123]	39 Subjects	58 Subjects	114 Subjects
Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) Anti-PD, Post-booster [N=43;66;118]	43 Subjects	66 Subjects	117 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	Preterm Group n=43 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=67 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=123 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Antibody Concentrations Against Protein D (Anti-PD) Anti-PD, Pre-booster [N=42;67;123]	478.3 EL.U/mL Interval 361.4 to 633.1	340.0 EL.U/mL Interval 258.1 to 447.9	383.7 EL.U/mL Interval 317.6 to 463.5
Antibody Concentrations Against Protein D (Anti-PD) Anti-PD, Post-booster [N=43;66;118]	1892.9 EL.U/mL Interval 1415.1 to 2532.2	1576.5 EL.U/mL Interval 1232.7 to 2016.1	1533.6 EL.U/mL Interval 1278.2 to 1840.1

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=23 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=34 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=60 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Anti-DT, Pre-booster [N=23;31;59]	20 Subjects	27 Subjects	51 Subjects
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Anti-DT, Post-booster [N=21;34;60]	21 Subjects	34 Subjects	60 Subjects
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Anti-TT, Pre-booster [N=23;32;59]	23 Subjects	32 Subjects	59 Subjects
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Anti-TT, Post-booster [N=21;34;60]	21 Subjects	34 Subjects	60 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	Preterm Group n=23 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=34 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=60 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Anti-DT, Pre-booster [N=23;31;59]	0.381 IU/mL Interval 0.21 to 0.689	0.674 IU/mL Interval 0.38 to 1.196	0.481 IU/mL Interval 0.324 to 0.716
Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Anti-DT, Post-booster [N=21;34;60]	6.252 IU/mL Interval 4.572 to 8.551	9.982 IU/mL Interval 7.392 to 13.478	6.730 IU/mL Interval 5.254 to 8.62
Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Anti-TT, Pre-booster [N=23;32;59]	0.821 IU/mL Interval 0.591 to 1.141	0.726 IU/mL Interval 0.601 to 0.877	0.918 IU/mL Interval 0.711 to 1.184
Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Anti-TT, Post-booster [N=21;34;60]	12.374 IU/mL Interval 9.629 to 15.903	14.392 IU/mL Interval 11.717 to 17.676	13.026 IU/mL Interval 11.176 to 15.183

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=23 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=34 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=59 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-PRP, Pre-booster [N=23;32;59]	16 Subjects	26 Subjects	50 Subjects
Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-PRP, Post-booster [N=20;34;59]	20 Subjects	34 Subjects	59 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=23 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=34 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=59 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL Anti-PRP, Pre-booster [N=23;32;59]	6 Subjects	9 Subjects	20 Subjects
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL Anti-PRP, Post-booster [N=20;34;59]	20 Subjects	34 Subjects	59 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	Preterm Group n=23 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=34 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=59 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Anti-PRP, Pre-booster [N=23;32;59]	0.376 µg/mL Interval 0.196 to 0.719	0.509 µg/mL Interval 0.312 to 0.832	0.577 µg/mL Interval 0.372 to 0.896
Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Anti-PRP, Post-booster [N=20;34;59]	33.731 µg/mL Interval 17.907 to 63.54	36.902 µg/mL Interval 25.148 to 54.148	38.713 µg/mL Interval 27.736 to 54.034

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=23 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=34 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=60 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN, Pre-booster [N=23;32;59]	20 Subjects	28 Subjects	47 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN, Post-booster [N=21;34;60]	21 Subjects	34 Subjects	60 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT, Pre-booster [N=22;32;58]	10 Subjects	11 Subjects	30 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT, Post-booster [N=21;34;59]	21 Subjects	34 Subjects	59 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA, Pre-booster [N=20;27;47]	19 Subjects	24 Subjects	43 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA, Post-booster [N=21;34;59]	21 Subjects	34 Subjects	59 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	Preterm Group n=23 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=34 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=60 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT, Pre-booster [N=22;32;58]	5.7 EL.U/mL Interval 3.3 to 9.8	3.8 EL.U/mL Interval 3.0 to 4.7	5.5 EL.U/mL Interval 4.4 to 6.9
Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT, Post-booster [N=21;34;59]	38.4 EL.U/mL Interval 29.8 to 49.5	32.7 EL.U/mL Interval 24.2 to 44.2	45.1 EL.U/mL Interval 37.0 to 54.9
Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA, Pre-booster [N=20;27;47]	39.4 EL.U/mL Interval 18.4 to 84.2	13.7 EL.U/mL Interval 9.3 to 20.1	17.0 EL.U/mL Interval 12.4 to 23.3
Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA, Post-booster [N=21;34;59]	250.3 EL.U/mL Interval 162.4 to 385.8	275.3 EL.U/mL Interval 207.0 to 366.1	229.0 EL.U/mL Interval 188.1 to 278.9
Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN, Pre-booster [N=23;32;59]	16.7 EL.U/mL Interval 9.4 to 29.9	10.3 EL.U/mL Interval 7.4 to 14.2	11.3 EL.U/mL Interval 8.7 to 14.8
Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN, Post-booster [N=21;34;60]	259.7 EL.U/mL Interval 151.5 to 445.2	286.5 EL.U/mL Interval 192.6 to 426.0	264.5 EL.U/mL Interval 200.2 to 349.5

SECONDARY outcome

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations \< 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration.

Outcome measures

Outcome measures
Measure	Preterm Group n=19 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=28 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=45 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT, S- [N=11;21;27]	11 Subjects	21 Subjects	27 Subjects
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT, S+ [N=9;11;27]	9 Subjects	11 Subjects	24 Subjects
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA, S- [N=1;3;4]	1 Subjects	3 Subjects	4 Subjects
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA, S+ [N=17;24;39]	17 Subjects	24 Subjects	37 Subjects
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN, S- [N=2;4;11]	2 Subjects	4 Subjects	11 Subjects
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN, S+ [N=19;28;45]	19 Subjects	28 Subjects	44 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.

Outcome measures

Outcome measures
Measure	Preterm Group n=17 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=29 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=53 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Anti-Polio 1, Pre-booster [N=17;29;53]	17 Subjects	22 Subjects	49 Subjects
Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Anti-Polio 1, Post-booster [N=3;8;20]	3 Subjects	8 Subjects	20 Subjects
Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Anti-Polio 2, Pre-booster [N=17;29;53]	17 Subjects	26 Subjects	47 Subjects
Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Anti-Polio 2, Post-booster [N=3;8;20]	3 Subjects	8 Subjects	20 Subjects
Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Anti-Polio 3, Pre-booster [N=17;29;53]	12 Subjects	23 Subjects	51 Subjects
Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Anti-Polio 3, Post-booster [N=3;8;20]	3 Subjects	8 Subjects	20 Subjects

SECONDARY outcome

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Preterm Group n=17 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=29 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=53 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Antibody Titers Against Anti-polio Type 1, 2 and 3 Anti-Polio 1, Pre-booster [N=17;29;53]	52.3 Titers Interval 31.2 to 87.6	34.8 Titers Interval 19.4 to 62.7	54.7 Titers Interval 37.7 to 79.3
Antibody Titers Against Anti-polio Type 1, 2 and 3 Anti-Polio 1, Post-booster [N=3;8;20]	512.0 Titers Interval 115.3 to 2274.0	1386.7 Titers Interval 456.6 to 4210.9	1327.9 Titers Interval 795.4 to 2217.1
Antibody Titers Against Anti-polio Type 1, 2 and 3 Anti-Polio 2, Pre-booster [N=17;29;53]	65.2 Titers Interval 37.4 to 113.7	47.3 Titers Interval 26.2 to 85.3	50.9 Titers Interval 33.7 to 76.7
Antibody Titers Against Anti-polio Type 1, 2 and 3 Anti-Polio 2, Post-booster [N=3;8;20]	1290.1 Titers Interval 147.8 to 11259.3	2048.0 Titers Interval 759.7 to 5520.9	1116.9 Titers Interval 600.9 to 2076.1
Antibody Titers Against Anti-polio Type 1, 2 and 3 Anti-Polio 3, Pre-booster [N=17;29;53]	23.0 Titers Interval 10.0 to 53.2	31.3 Titers Interval 16.8 to 58.4	84.3 Titers Interval 59.0 to 120.4
Antibody Titers Against Anti-polio Type 1, 2 and 3 Anti-Polio 3, Post-booster [N=3;8;20]	574.7 Titers Interval 36.1 to 9148.9	1448.1 Titers Interval 464.0 to 4519.2	1692.5 Titers Interval 1147.7 to 2495.9

SECONDARY outcome

Timeframe: Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose.

Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	Preterm Group n=2 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=1 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=12 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs)	21.9 mIU/mL Interval 1.9 to 246.8	117.2 mIU/mL Interval 117.2 to 117.2	37.2 mIU/mL Interval 15.6 to 88.8

SECONDARY outcome

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Outcome measures

Outcome measures
Measure	Preterm Group n=38 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=55 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=100 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-1, [N=37;52;99]	34 Subjects	49 Subjects	93 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-4, [N=36;55;100]	35 Subjects	55 Subjects	100 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-5, [N=34;50;93]	32 Subjects	48 Subjects	92 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-6B, [N=35;51;98]	33 Subjects	49 Subjects	92 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-7F, [N=37;49;99]	37 Subjects	49 Subjects	99 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-9V, [N=38;47;100]	38 Subjects	47 Subjects	100 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-14, [N=36;52;99]	36 Subjects	52 Subjects	99 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-18C, [N=37;50;100]	37 Subjects	50 Subjects	100 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-19F, [N=36;52;96]	36 Subjects	51 Subjects	96 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-23F, [N=37;54;99]	37 Subjects	54 Subjects	99 Subjects

SECONDARY outcome

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Preterm Group n=38 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=55 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=100 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-1, [N=37;52;99]	125 Titers Interval 74.1 to 210.8	143.6 Titers Interval 93.1 to 221.3	170.9 Titers Interval 124.6 to 234.3
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-4, [N=36;55;100]	971.8 Titers Interval 623.7 to 1514.1	1307.2 Titers Interval 1070.0 to 1596.9	1479.3 Titers Interval 1259.6 to 1737.3
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-5, [N=34;50;93]	69.2 Titers Interval 45.0 to 106.4	120.0 Titers Interval 81.2 to 177.1	176.9 Titers Interval 138.1 to 226.5
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-6B, [N=35;51;98]	659.0 Titers Interval 353.9 to 1227.3	459.1 Titers Interval 286.7 to 735.3	635.0 Titers Interval 437.3 to 922.1
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-7F, [N=37;49;99]	6008.9 Titers Interval 4318.7 to 8360.5	4851.1 Titers Interval 3954.4 to 5951.1	4372.6 Titers Interval 3658.8 to 5225.5
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-9V, [N=38;47;100]	1666.4 Titers Interval 1218.1 to 2279.6	2192.5 Titers Interval 1724.3 to 2787.8	1798.8 Titers Interval 1522.8 to 2124.7
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-14, [N=36;52;99]	1489.5 Titers Interval 980.7 to 2262.3	1895.3 Titers Interval 1477.3 to 2431.7	1342.7 Titers Interval 1095.4 to 1646.0
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-18C, [N=37;50;100]	1656.0 Titers Interval 1005.6 to 2727.0	1672.4 Titers Interval 1154.4 to 2422.9	1561.9 Titers Interval 1251.2 to 1949.8
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-19F, [N=36;52;96]	379.3 Titers Interval 241.3 to 596.2	486.3 Titers Interval 327.9 to 721.3	626.8 Titers Interval 473.1 to 830.3
Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes OPA Anti-23F, [N=37;54;99]	2881.8 Titers Interval 1956.7 to 4244.3	2510.2 Titers Interval 2076.2 to 3035.0	3208.6 Titers Interval 2667.3 to 3859.8

SECONDARY outcome

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.

Outcome measures

Outcome measures
Measure	Preterm Group n=38 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=52 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=95 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A OPA Anti-6A, [N=34;50;95]	31 Subjects	45 Subjects	79 Subjects
Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A OPA Anti-19A, [N=38;52;95]	23 Subjects	30 Subjects	56 Subjects

SECONDARY outcome

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Preterm Group n=38 Participants Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=52 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=95 Participants Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A OPA Anti-6A, [N=34;50;95]	270.6 Titers Interval 152.9 to 478.6	218.2 Titers Interval 137.4 to 346.6	207.4 Titers Interval 136.8 to 314.4
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A OPA Anti-19A, [N=38;52;95]	31.9 Titers Interval 16.0 to 63.6	41.4 Titers Interval 22.0 to 77.8	51.7 Titers Interval 32.1 to 83.5

Adverse Events

Preterm Group

Serious events: 3 serious events

Other events: 71 other events

Deaths: 0 deaths

Full Term Group

Serious events: 1 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Preterm Group n=116 participants at risk Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=129 participants at risk Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.86% 1/116 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	0.00% 0/129 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
Nervous system disorders Febrile convulsion	0.86% 1/116 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	0.00% 0/129 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
Infections and infestations Latent tuberculosis	0.00% 0/116 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	0.78% 1/129 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
Infections and infestations Pyelonephritis acute	0.86% 1/116 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	0.00% 0/129 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.

Other adverse events

Other adverse events
Measure	Preterm Group n=116 participants at risk Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.	Full Term Group n=129 participants at risk Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
General disorders Pain	42.0% 47/112 • Number of events 47 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	54.9% 67/122 • Number of events 67 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
General disorders Redness	31.2% 35/112 • Number of events 35 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	53.3% 65/122 • Number of events 65 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
General disorders Swelling	24.1% 27/112 • Number of events 27 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	45.1% 55/122 • Number of events 55 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
General disorders Drowsiness	18.8% 21/112 • Number of events 21 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	27.0% 33/122 • Number of events 33 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
General disorders Fever (rectal temperature measurement)	30.4% 34/112 • Number of events 34 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	32.0% 39/122 • Number of events 39 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
General disorders Irritability	32.1% 36/112 • Number of events 36 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	40.2% 49/122 • Number of events 49 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.
General disorders Loss of appetite	23.2% 26/112 • Number of events 26 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.	28.7% 35/122 • Number of events 35 • Solicited local and general symptoms: during the 4-days (Day 0-3) post-booster vaccination. Unsolicited AEs: within 31-days (Day 0-30) post-booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study.

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.
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