Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Conditions
Keywords
Streptococcus pneumoniae, Haemophilus influenzae, Pneumococcal conjugate vaccine, Antibody persistence
Brief summary
This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).
Detailed description
This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Months to 32 Months
Healthy volunteers
Yes
Inclusion criteria
* Male or female between, and including, 28-30 months of age at the time of first blood sampling. * Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * Written informed consent, covering visits 1, 2 and 3, obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling * Administration of any additional pneumococcal vaccine since end of 107046 study. * Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling. * Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling. * Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off. |
| Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme -linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off. |
| Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | Anti-pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F . Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT). |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007) | Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT). |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT-007) | Pneumococcal serotypes assessed were pneumococcal serotypes OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT). |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT). |
| Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micrograms per milliliter (µg/mL). |
| Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) | At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PDDIT- 007) | The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micrograms per milliliter (µg/mL). |
| Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT- 007) | Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. |
| Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. |
| Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT). |
| Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007) | Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT). |
| Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007) | Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT). |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT). |
| Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study) | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. |
| Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study) | At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT- 007) | Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. |
| Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT- 007) | Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. |
| Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. |
| Number of Subjects Reported With Solicited Local Symptoms | Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study | Solicited local symptoms assessed were pain, redness and swelling. Any occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom greater than (\>) 0 millimeter (mm). Grade 3 pain = maximum intensity of local injection defined as subject crying when limb was moved/spontaneously painful. Grade 3 redness/swelling= maximum intensity of local injection \>30 mm. Follow-up period was of 4 days (Days 0-3) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 4 days for primed subjects and 2 periods of 4 days for unprimed subjects. |
| Number of Subjects Reported With Solicited General Symptoms | Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (any fever defined as temperature by axillary measurement of 37.5°C and above). Grade 3 drowsiness was defined as drowsiness that prevented normal activity; Grade 3 irritability was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as subject not eating at all. Grade 3 fever was defined as axillary temperature \>39.5°C. Related AE was defined as any AE assessed by investigators to be causally related to administration of the study vaccine. Follow-up period was of 4 days (Days 0-3) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 4 days for primed subjects and 2 periods of 4 days for unprimed subjects. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within 31 days (Day 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Follow-up period was of 31 days (Days 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 31 days for primed subjects and 2 periods of 31 days for unprimed subjects. |
| Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)] | During Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) i.e. for each primed subject: from the time the subject was enrolled in the 111345 study until he/she completed the same study (approximatively 12 months) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any was defined an incidence of a SAE regardless of intensity/severity. |
| Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [(Follow-up Period: Year 2 (111346 Sub-study) Until Year 4 (111347 Sub-study)] | From Year (Y) 2 to Y4 FU visit (post booster vaccination administered in 10PN-PD-DIT-007) i.e. for each subject(S): when S was enrolled in 111346 study until S completed the same study visit or the 111347 study visit (range of 1 to 3 years for each S)) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity. |
| Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibation ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL. |
| Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)] | For primed groups: from Months 48-49 (additional vaccination period); for unprimed group: from Day 0 up to Month 3 (catch-up vaccination period) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity. |
| Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8. |
| Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8. |
| Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8. |
| Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Analysis was performed with Unprimed group included. The seropositivity cut-off for the assay was 8. |
| Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The results for the immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL. |
| Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL. |
| Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL. |
| Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were mesured by Opsonophagocytic activity (OPA). The seropositivity cut-off for the assay was 8. |
| Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic activity (OPA). The seropositivity cut-off for the assay was 8. |
| Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic Activity (OPA). The seropositivity cut-off for the assay was 8. |
| Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic Activity (OPA). The seropositivity cut-off for the assay was 8. |
| Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML. |
| Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)] | At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML. |
| Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) | Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL).The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. |
| Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML. |
| Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off. |
| Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007) | A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML. |
| Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007) | Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. |
| Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007) | Pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. |
Countries
Poland
Participant flow
Recruitment details
Primed groups included Synflorix vaccinated subjects in study 10PN-PD-DIT-007. The Unprimed Group, added only in Year 4,included subjects unprimed with any pneumococcal vaccine age-matched with primed groups. The study included 3 sub-studies (111345, 111346, 111347) corresponding to Year 1, 2 and 4 time points post Dose 1 in Study 10PN-PD-DIT-001.
Pre-assignment details
At screening, subjects with previous participation in 10PN-PD-DIT-007 study were invited to join this study. Informed consent was obtained and signed from subjects' parents/guardians, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected.
Participants by arm
| Arm | Count |
|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix). | 391 |
| Prevenar + Infanrix + Havrix and/or Varilrix Group This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix). | 31 |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix). | 102 |
| Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2).
The Unprimed Group was added only in Year 4 of the study. | 100 |
| Total | 624 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Follow-up Period: Year 4 | Lost to Follow-up | 1 | 1 | 0 | 0 |
| Follow-up Period: Year 4 | Parents decision | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Synflorix + Infanrix + Havrix and/or Varilrix Group | Prevenar + Infanrix + Havrix and/or Varilrix Group | Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Total | Unprimed Group |
|---|---|---|---|---|---|
| Age, Continuous | 67.4 Months STANDARD_DEVIATION 0.84 | 67.1 Months STANDARD_DEVIATION 0.97 | 67.3 Months STANDARD_DEVIATION 0.89 | 66.9 Months STANDARD_DEVIATION 1.28 | 65.4 Months STANDARD_DEVIATION 1.31 |
| Race/Ethnicity, Customized Other, not specified | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White arabic/ north african heritage | 4 Participants | 0 Participants | 4 Participants | 8 Participants | 0 Participants |
| Race/Ethnicity, Customized White - caucasia/ european heritage | 386 Participants | 31 Participants | 102 Participants | 519 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian heritage | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other, not specified | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic / North African heritage | 4 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Arabic/North African heritage | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Caucasian / European heritage | 365 Participants | 31 Participants | 96 Participants | 492 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Caucasian/ European heritage | 261 Participants | 20 Participants | 65 Participants | 444 Participants | 98 Participants |
| Sex: Female, Male Female | 139 Participants | 14 Participants | 35 Participants | 237 Participants | 53 Participants |
| Sex: Female, Male Male | 178 Participants | 17 Participants | 50 Participants | 255 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 391 | 0 / 31 | 0 / 102 | 0 / 100 |
| other Total, other adverse events | 188 / 264 | 12 / 20 | 39 / 65 | 65 / 100 |
| serious Total, serious adverse events | 1 / 391 | 0 / 31 | 0 / 102 | 0 / 100 |
Outcome results
Primary
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 antibodies, Y1 | 372 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 antibodies, Y1 | 384 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 antibodies, Y1 | 386 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B antibodies, Y1 | 384 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F antibodies, Y1 | 387 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V antibodies, Y1 | 388 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 antibodies, Y1 | 387 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C antibodies, Y1 | 384 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F antibodies, Y1 | 387 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F antibodies, Y1 | 386 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F antibodies, Y1 | 31 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 antibodies, Y1 | 7 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V antibodies, Y1 | 17 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F antibodies, Y1 | 17 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 antibodies, Y1 | 31 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F antibodies, Y1 | 31 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C antibodies, Y1 | 31 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 antibodies, Y1 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 antibodies, Y1 | 31 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B antibodies, Y1 | 31 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C antibodies, Y1 | 102 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B antibodies, Y1 | 100 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F antibodies, Y1 | 102 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V antibodies, Y1 | 102 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F antibodies, Y1 | 102 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 antibodies, Y1 | 102 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 antibodies, Y1 | 99 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F antibodies, Y1 | 102 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 antibodies, Y1 | 102 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 antibodies, Y1 | 101 Participants |
Primary
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme -linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.
Time frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F antibodies, Y2 | 357 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V antibodies, Y2 | 362 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 antibodies, Y2 | 354 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 antibodies, Y2 | 356 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B antibodies, Y2 | 355 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 antibodies, Y2 | 362 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 antibodies, Y2 | 367 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F antibodies, Y2 | 367 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C antibodies, Y2 | 365 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F antibodies, Y2 | 368 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F antibodies, Y2 | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 antibodies, Y2 | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F antibodies, Y2 | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 antibodies, Y2 | 18 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V antibodies, Y2 | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B antibodies, Y2 | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 antibodies, Y2 | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C antibodies, Y2 | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F antibodies, Y2 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 antibodies, Y2 | 21 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C antibodies, Y2 | 96 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B antibodies, Y2 | 95 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F antibodies, Y2 | 95 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V antibodies, Y2 | 96 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 antibodies, Y2 | 96 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 antibodies, Y2 | 95 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F antibodies, Y2 | 95 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F antibodies, Y2 | 95 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 antibodies, Y2 | 90 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 antibodies, Y2 | 96 Participants |
Primary
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.
Time frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, Y4 | 238 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, Y4 | 238 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, Y4 | 257 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, Y4 | 258 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, Y4 | 260 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, Y4 | 255 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, Y4 | 263 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, Y4 | 256 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, Y4 | 260 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, Y4 | 254 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, Y4 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, Y4 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, Y4 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, Y4 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, Y4 | 18 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, Y4 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, Y4 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, Y4 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, Y4 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, Y4 | 19 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, Y4 | 73 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, Y4 | 74 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, Y4 | 73 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, Y4 | 75 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, Y4 | 75 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, Y4 | 75 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, Y4 | 71 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, Y4 | 74 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, Y4 | 72 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, Y4 | 73 Participants |
Secondary
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, D7 | 2.79 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, D7 | 2.2 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, D7 | 2.44 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, D7 | 1.67 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, D7 | 1.33 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, D7 | 1.72 μg/mL |
| Unprimed Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, M3 | 2.39 μg/mL |
| Unprimed Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, D7 | 0.44 μg/mL |
| Unprimed Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, M3 | 0.92 μg/mL |
| Unprimed Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, PRE | 0.44 μg/mL |
| Unprimed Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, D7 | 1.1 μg/mL |
| Unprimed Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, PRE | 0.2 μg/mL |
Secondary
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micrograms per milliliter (µg/mL).
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A antibodies, Y1 | 0.28 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A antibodies, Y1 | 0.28 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A antibodies, Y1 | 0.44 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A antibodies, Y1 | 0.21 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A antibodies, Y1 | 0.27 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A antibodies, Y1 | 0.23 μg/mL |
Secondary
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)
The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micrograms per milliliter (µg/mL).
Time frame: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PDDIT- 007)
Population: The analysis was performed on the ATP cohort for persistence, which included all subjects from the total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) | Anti-6A antibodies, Y2 | 0.33 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) | Anti-19A antibodies, Y2 | 0.37 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) | Anti-6A antibodies, Y2 | 0.57 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) | Anti-19A antibodies, Y2 | 0.25 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) | Anti-6A antibodies, Y2 | 0.4 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) | Anti-19A antibodies, Y2 | 0.35 μg/mL |
Secondary
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.
Time frame: At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT- 007)
Population: The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 Study, for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, Y4 | 0.92 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, Y4 | 1.3 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, Y4 | 0.69 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, Y4 | 1.08 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, Y4 | 0.75 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, Y4 | 1.14 μg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
Anti-pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F . Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, D7 | 11.63 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, D7 | 3.68 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, D7 | 6.5 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, D7 | 15.51 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, D7 | 12.11 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, D7 | 5.36 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, D7 | 9.94 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, D7 | 19.38 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, D7 | 6.23 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, D7 | 7.16 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, D7 | 3.24 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, D7 | 9 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, D7 | 10.45 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, D7 | 13.26 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, D7 | 2.85 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, D7 | 19.71 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, D7 | 3.04 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, D7 | 16.44 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, D7 | 3.26 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, D7 | 9.34 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, D7 | 4.7 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, D7 | 8.09 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, D7 | 5 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, D7 | 18.61 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, D7 | 7.57 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, D7 | 5.32 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, D7 | 2.15 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, D7 | 13.34 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, D7 | 8.15 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, D7 | 7.13 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, M3 | 1.63 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, PRE | 0.1 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, D7 | 1.35 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, M3 | 2.39 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, PRE | 0.04 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, D7 | 4.74 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, M3 | 7.32 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, PRE | 0.1 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, D7 | 1.2 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, M3 | 3.1 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, PRE | 0.21 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, D7 | 0.53 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, M3 | 1.25 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, PRE | 0.12 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, D7 | 1.67 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, M3 | 4.55 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, PRE | 0.19 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, M3 | 2.2 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, PRE | 0.58 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, D7 | 1.72 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, M3 | 7.81 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, PRE | 0.1 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, D7 | 2.26 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, M3 | 13.21 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, PRE | 0.6 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, D7 | 5.12 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, M3 | 15.47 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, PRE | 0.1 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, D7 | 0.42 μg/mL |
| Unprimed Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, D7 | 0.9 μg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL).The seropositivity cut-off for the assay was ≥ 0.05 µg/mL.
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 antibodies, Y1 | 0.29 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 antibodies, Y1 | 0.5 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 antibodies, Y1 | 0.59 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B antibodies, Y1 | 0.52 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F antibodies, Y1 | 0.71 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V antibodies, Y1 | 0.79 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 antibodies, Y1 | 1.27 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C antibodies, Y1 | 0.88 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F antibodies, Y1 | 1.43 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F antibodies, Y1 | 0.61 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F antibodies, Y1 | 0.83 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 antibodies, Y1 | 0.04 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V antibodies, Y1 | 0.93 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F antibodies, Y1 | 0.08 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 antibodies, Y1 | 0.59 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F antibodies, Y1 | 1.18 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C antibodies, Y1 | 0.91 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 antibodies, Y1 | 0.07 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 antibodies, Y1 | 1.79 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B antibodies, Y1 | 0.98 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C antibodies, Y1 | 0.82 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B antibodies, Y1 | 0.54 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F antibodies, Y1 | 0.83 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V antibodies, Y1 | 0.58 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F antibodies, Y1 | 1.51 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 antibodies, Y1 | 1.47 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 antibodies, Y1 | 0.26 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F antibodies, Y1 | 0.7 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 antibodies, Y1 | 1.01 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 antibodies, Y1 | 0.42 µg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)]
Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL.
Time frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 antibodies, Y2 | 0.19 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 antibodies, Y2 | 0.27 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 antibodies, Y2 | 0.41 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B antibodies, Y2 | 0.7 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F antibodies, Y2 | 0.53 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V antibodies, Y2 | 0.64 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 antibodies, Y2 | 1.73 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C antibodies, Y2 | 0.54 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F antibodies, Y2 | 2.16 µg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F antibodies, Y2 | 0.68 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F antibodies, Y2 | 0.99 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 antibodies, Y2 | 0.07 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V antibodies, Y2 | 0.61 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F antibodies, Y2 | 0.1 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 antibodies, Y2 | 0.3 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F antibodies, Y2 | 1.24 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C antibodies, Y2 | 0.59 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 antibodies, Y2 | 0.09 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 antibodies, Y2 | 1.94 µg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B antibodies, Y2 | 0.99 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C antibodies, Y2 | 0.48 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B antibodies, Y2 | 0.9 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F antibodies, Y2 | 0.59 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V antibodies, Y2 | 0.5 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F antibodies, Y2 | 2.41 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 antibodies, Y2 | 1.7 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 antibodies, Y2 | 0.17 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F antibodies, Y2 | 0.64 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 antibodies, Y2 | 0.52 µg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 antibodies, Y2 | 0.33 µg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
Pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.
Time frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, Y4 | 0.2 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, Y4 | 0.19 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, Y4 | 0.36 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, Y4 | 1.3 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, Y4 | 0.44 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, Y4 | 1.17 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, Y4 | 3.66 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, Y4 | 0.7 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, Y4 | 4.17 μg/mL |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, Y4 | 1.57 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, Y4 | 4.74 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, Y4 | 0.17 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, Y4 | 1.19 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, Y4 | 0.16 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, Y4 | 0.23 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, Y4 | 1.64 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, Y4 | 0.87 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, Y4 | 0.19 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, Y4 | 2.57 μg/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, Y4 | 1.19 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, Y4 | 0.63 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, Y4 | 0.97 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, Y4 | 0.49 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, Y4 | 0.67 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, Y4 | 4.05 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, Y4 | 2.94 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, Y4 | 0.23 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, Y4 | 1.12 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, Y4 | 0.31 μg/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, Y4 | 0.35 μg/mL |
Secondary
Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, D7 | 2106 EL.U/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, D7 | 718.2 EL.U/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, D7 | 680.7 EL.U/mL |
| Unprimed Group | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, PRE | 106 EL.U/mL |
| Unprimed Group | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, D7 | 382.9 EL.U/mL |
| Unprimed Group | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, M3 | 708.6 EL.U/mL |
Secondary
Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study) | 822.1 EL.U/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study) | 93.9 EL.U/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study) | 193.6 EL.U/mL |
Secondary
Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Time frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT- 007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study) | 573.2 EL.U/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study) | 116.7 EL.U/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study) | 157.5 EL.U/mL |
Secondary
Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Time frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT- 007)
Population: The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 study for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | 372.4 EL.U/mL |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | 144.9 EL.U/mL |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | 161.4 EL.U/mL |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, D7 | 208 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, D7 | 208 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, D7 | 14 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, D7 | 54 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, D7 | 92 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, M3 | 97 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, PRE | 88 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, D7 | 97 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, PRE | 76 Participants |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The results for the immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A antibodies, Y1 | 376 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A antibodies, Y1 | 366 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A antibodies, Y1 | 31 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A antibodies, Y1 | 29 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A antibodies, Y1 | 97 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A antibodies, Y1 | 93 Participants |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibation ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.
Time frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A antibodies, Y2 | 330 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A antibodies, Y2 | 319 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A antibodies, Y2 | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A antibodies, Y2 | 25 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A antibodies, Y2 | 86 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A antibodies, Y2 | 83 Participants |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.
Time frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, Y4 | 256 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, Y4 | 260 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, Y4 | 18 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, Y4 | 18 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A antibodies, Y4 | 72 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A antibodies, Y4 | 74 Participants |
Secondary
Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, D7 | 207 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, D7 | 14 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, D7 | 54 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, PRE | 54 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, D7 | 92 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-PD antibodies, M3 | 98 Participants |
Secondary
Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | 373 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | 11 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | 71 Participants |
Secondary
Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)]
A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.
Time frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)] | 340 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)] | 15 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)] | 65 Participants |
Secondary
Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.
Time frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | 241 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | 12 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | 54 Participants |
Secondary
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, D7 | 208 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, D7 | 208 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, D7 | 208 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, D7 | 208 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, D7 | 208 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, D7 | 207 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, D7 | 207 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, D7 | 208 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, D7 | 207 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, D7 | 207 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, D7 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, D7 | 14 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, D7 | 54 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, D7 | 54 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, D7 | 97 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, PRE | 29 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, D7 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, PRE | 72 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, D7 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, PRE | 77 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, D7 | 94 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, PRE | 64 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, D7 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, PRE | 67 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, D7 | 94 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, PRE | 90 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, D7 | 97 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, PRE | 52 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, D7 | 97 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, PRE | 75 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, D7 | 97 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F antibodies, M3 | 98 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, PRE | 54 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F antibodies, D7 | 90 Participants |
| Unprimed Group | Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 antibodies, PRE | 69 Participants |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic Activity (OPA). The seropositivity cut-off for the assay was 8.
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA, D7 | 173 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA, D7 | 185 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA, D7 | 11 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA, D7 | 12 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA, D7 | 46 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA, D7 | 36 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA, M3 | 87 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA, D7 | 88 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA, M3 | 87 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA, PRE | 25 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA, D7 | 81 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA, PRE | 57 Participants |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were mesured by Opsonophagocytic activity (OPA). The seropositivity cut-off for the assay was 8.
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A OPA, Y1 | 196 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A OPA, Y1 | 45 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A OPA, Y1 | 24 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A OPA, Y1 | 3 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A OPA, Y1 | 45 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A OPA, Y1 | 10 Participants |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic activity (OPA). The seropositivity cut-off for the assay was 8.
Time frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A OPA, Y2 | 235 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A OPA, Y2 | 115 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A OPA, Y2 | 21 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A OPA, Y2 | 8 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A OPA, Y2 | 62 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A OPA, Y2 | 29 Participants |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic Activity (OPA). The seropositivity cut-off for the assay was 8.
Time frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, Y4 | 194 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, Y4 | 135 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, Y4 | 12 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, Y4 | 7 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, Y4 | 51 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, Y4 | 34 Participants |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 OPA, Y1 | 188 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 OPA, Y1 | 201 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 OPA, Y1 | 241 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B OPA, Y1 | 164 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F OPA, Y1 | 343 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V OPA, Y1 | 351 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 OPA, Y1 | 336 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C OPA, Y1 | 173 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F OPA, Y1 | 306 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F OPA, Y1 | 301 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F OPA, Y1 | 19 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 OPA, Y1 | 2 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V OPA, Y1 | 26 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F OPA, Y1 | 20 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 OPA, Y1 | 21 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F OPA, Y1 | 26 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C OPA, Y1 | 10 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 OPA, Y1 | 2 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 OPA, Y1 | 25 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B OPA, Y1 | 23 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C OPA, Y1 | 25 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B OPA, Y1 | 44 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F OPA, Y1 | 85 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V OPA, Y1 | 90 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F OPA, Y1 | 83 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 OPA, Y1 | 89 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 OPA, Y1 | 26 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F OPA, Y1 | 82 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 OPA, Y1 | 65 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 OPA, Y1 | 46 Participants |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.
Time frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 OPA, Y2 | 92 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 OPA, Y2 | 146 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 OPA, Y2 | 169 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B OPA, Y2 | 241 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F OPA Titers, Y2 | 350 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V OPA, Y2 | 347 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 OPA, Y2 | 333 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C OPA, Y2 | 165 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F OPA, Y2 | 279 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F OPA, Y2 | 285 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F OPA, Y2 | 21 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 OPA, Y2 | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V OPA, Y2 | 27 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F OPA Titers, Y2 | 26 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 OPA, Y2 | 12 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F OPA, Y2 | 25 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C OPA, Y2 | 11 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 OPA, Y2 | 2 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 OPA, Y2 | 24 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B OPA, Y2 | 24 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C OPA, Y2 | 29 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B OPA, Y2 | 67 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F OPA Titers, Y2 | 90 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V OPA, Y2 | 87 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F OPA, Y2 | 78 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 OPA, Y2 | 85 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 OPA, Y2 | 15 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F OPA, Y2 | 72 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 OPA, Y2 | 48 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 OPA, Y2 | 31 Participants |
Secondary
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.
Time frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, Y4 | 55 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, Y4 | 107 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, Y4 | 80 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, Y4 | 223 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, Y4 | 248 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, Y4 | 242 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, Y4 | 247 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, Y4 | 121 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, Y4 | 211 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, Y4 | 209 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, Y4 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, Y4 | 1 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, Y4 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, Y4 | 15 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, Y4 | 8 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, Y4 | 15 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, Y4 | 8 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, Y4 | 2 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, Y4 | 14 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, Y4 | 15 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, Y4 | 27 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, Y4 | 62 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, Y4 | 71 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, Y4 | 68 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, Y4 | 62 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, Y4 | 70 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, Y4 | 17 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, Y4 | 55 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, Y4 | 33 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, Y4 | 11 Participants |
Secondary
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Analysis was performed with Unprimed group included. The seropositivity cut-off for the assay was 8.
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, D7 | 194 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, D7 | 197 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, D7 | 199 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, D7 | 197 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, D7 | 201 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, D7 | 186 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, D7 | 196 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, D7 | 194 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, D7 | 190 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, D7 | 193 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, D7 | 13 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, D7 | 13 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, D7 | 48 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, D7 | 51 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, D7 | 50 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, D7 | 51 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, D7 | 48 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, D7 | 47 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, D7 | 48 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, D7 | 50 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, D7 | 50 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, D7 | 49 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, M3 | 95 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, D7 | 90 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, M3 | 87 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, PRE | 17 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, D7 | 93 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA, M3 | 94 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, PRE | 8 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, D7 | 87 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA, M3 | 89 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, PRE | 35 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, D7 | 84 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA, M3 | 94 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, PRE | 67 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, D7 | 93 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA, M3 | 93 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, PRE | 75 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, D7 | 93 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA, M3 | 94 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, PRE | 81 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, D7 | 94 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA, M3 | 95 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, PRE | 7 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, D7 | 88 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA, M3 | 92 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, PRE | 30 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, D7 | 91 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA, M3 | 93 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, PRE | 47 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA, D7 | 95 Participants |
| Unprimed Group | Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA, PRE | 8 Participants |
Secondary
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (any fever defined as temperature by axillary measurement of 37.5°C and above). Grade 3 drowsiness was defined as drowsiness that prevented normal activity; Grade 3 irritability was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as subject not eating at all. Grade 3 fever was defined as axillary temperature \>39.5°C. Related AE was defined as any AE assessed by investigators to be causally related to administration of the study vaccine. Follow-up period was of 4 days (Days 0-3) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 4 days for primed subjects and 2 periods of 4 days for unprimed subjects.
Time frame: Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study
Population: The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Fever, Any | 13 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Grade 3 | 1 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Any | 49 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Related | 30 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Related | 48 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Fever, Related | 13 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Any | 35 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Grade 3 | 1 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Fever, >39,5°C | 0 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Related | 35 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Grade 3 | 0 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Any | 30 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Grade 3 | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Any | 3 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Fever, Related | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Related | 3 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Any | 4 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Grade 3 | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Fever, Any | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Any | 2 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Grade 3 | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Related | 2 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Fever, >39,5°C | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Related | 4 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Grade 3 | 1 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Any | 12 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Grade 3 | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Related | 11 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Irritability, Any | 6 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Irritability, Related | 6 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Irritability, Grade 3 | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Any | 6 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Related | 5 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Fever, Any | 2 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Fever, >39,5°C | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited General Symptoms | Fever, Related | 1 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Grade 3 | 0 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Related | 8 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Fever, Related | 5 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Fever, Any | 5 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Irritability, Any | 8 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Any | 12 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Fever, >39,5°C | 0 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Related | 11 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Grade 3 | 0 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Any | 13 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Drowsiness, Grade 3 | 0 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited General Symptoms | Loss of appetite, Related | 11 Participants |
Secondary
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom greater than (\>) 0 millimeter (mm). Grade 3 pain = maximum intensity of local injection defined as subject crying when limb was moved/spontaneously painful. Grade 3 redness/swelling= maximum intensity of local injection \>30 mm. Follow-up period was of 4 days (Days 0-3) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 4 days for primed subjects and 2 periods of 4 days for unprimed subjects.
Time frame: Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study
Population: The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Pain, Any | 157 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Redness, Any | 90 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Swelling, Any | 67 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Pain, Grade 3 | 7 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Redness, Grade 3 (> 30 mm) | 7 Participants |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Swelling, Grade 3 (> 30 mm) | 5 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Swelling, Grade 3 (> 30 mm) | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Pain, Grade 3 | 1 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Pain, Any | 9 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Swelling, Any | 4 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Redness, Any | 5 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects Reported With Solicited Local Symptoms | Redness, Grade 3 (> 30 mm) | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited Local Symptoms | Redness, Any | 14 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited Local Symptoms | Swelling, Any | 15 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited Local Symptoms | Pain, Grade 3 | 5 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited Local Symptoms | Swelling, Grade 3 (> 30 mm) | 1 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited Local Symptoms | Redness, Grade 3 (> 30 mm) | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects Reported With Solicited Local Symptoms | Pain, Any | 34 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited Local Symptoms | Redness, Grade 3 (> 30 mm) | 1 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited Local Symptoms | Swelling, Grade 3 (> 30 mm) | 2 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited Local Symptoms | Redness, Any | 21 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited Local Symptoms | Pain, Grade 3 | 3 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited Local Symptoms | Pain, Any | 54 Participants |
| Unprimed Group | Number of Subjects Reported With Solicited Local Symptoms | Swelling, Any | 20 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)]
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity.
Time frame: For primed groups: from Months 48-49 (additional vaccination period); for unprimed group: from Day 0 up to Month 3 (catch-up vaccination period)
Population: The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects in study 111347. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)] | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)] | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)] | 0 Participants |
| Unprimed Group | Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)] | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)]
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any was defined an incidence of a SAE regardless of intensity/severity.
Time frame: During Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) i.e. for each primed subject: from the time the subject was enrolled in the 111345 study until he/she completed the same study (approximatively 12 months)
Population: The analysis was performed on the primed subjects who were enrolled in the applicable 111345 Year 1 Follow-Up Study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)] | 1 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)] | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)] | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [(Follow-up Period: Year 2 (111346 Sub-study) Until Year 4 (111347 Sub-study)]
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity.
Time frame: From Year (Y) 2 to Y4 FU visit (post booster vaccination administered in 10PN-PD-DIT-007) i.e. for each subject(S): when S was enrolled in 111346 study until S completed the same study visit or the 111347 study visit (range of 1 to 3 years for each S))
Population: The analysis was performed on the Total enrolled cohort which included all primed subjects from Y2 follow-up sub-study 111346 and from Y4 long-term follow-up sub-study 111347 for antibody persistence for whom data concerning antibody persistence were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [(Follow-up Period: Year 2 (111346 Sub-study) Until Year 4 (111347 Sub-study)] | 0 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [(Follow-up Period: Year 2 (111346 Sub-study) Until Year 4 (111347 Sub-study)] | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [(Follow-up Period: Year 2 (111346 Sub-study) Until Year 4 (111347 Sub-study)] | 0 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Follow-up period was of 31 days (Days 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 31 days for primed subjects and 2 periods of 31 days for unprimed subjects.
Time frame: Within 31 days (Day 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study
Population: The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 25 Participants |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 0 Participants |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Number of Subjects With Unsolicited Adverse Events (AEs) | 3 Participants |
| Unprimed Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 6 Participants |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A OPA Titers, Y1 | 59 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A OPA Titers, Y1 | 6 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A OPA Titers, Y1 | 610.2 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A OPA Titers, Y1 | 5.9 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6A OPA Titers, Y1 | 46.6 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19A OPA Titers, Y1 | 5.5 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]
Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).
Time frame: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A OPA Titers, Y2 | 121.8 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A OPA Titers, Y2 | 12.8 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A OPA Titers, Y2 | 356.5 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A OPA Titers, Y2 | 10.9 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6A OPA Titers, Y2 | 133.7 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19A OPA Titers, Y2 | 11.1 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).
Time frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 Study for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, Y4 | 213.5 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, Y4 | 31.2 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, Y4 | 227.8 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, Y4 | 14.3 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, Y4 | 153.5 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, Y4 | 21.8 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, D7 | 467 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, D7 | 1217.7 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, D7 | 437.6 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, D7 | 1490.2 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, D7 | 467.7 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, D7 | 106.1 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, M3 | 376.4 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, D7 | 826.5 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, M3 | 943.4 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, PRE | 9.9 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19A OPA Titers, D7 | 431.2 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6A OPA Titers, PRE | 102.6 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]
Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).
Time frame: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, D7 | 1346.4 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, D7 | 8572.3 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, D7 | 25196.4 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, D7 | 8700.4 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, D7 | 9419.4 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, D7 | 822.3 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, D7 | 3513.1 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, D7 | 23633.7 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, D7 | 3378.9 Titers |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, D7 | 2920.8 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, D7 | 2340.4 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, D7 | 3566.6 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, D7 | 1331 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, D7 | 17828.8 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, D7 | 4192.8 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, D7 | 12234.7 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, D7 | 11341.1 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, D7 | 3478.6 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, D7 | 10650.3 Titers |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, D7 | 375.6 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, D7 | 1663.2 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, D7 | 7730.3 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, D7 | 8592.8 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, D7 | 6883.1 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, D7 | 1590.5 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, D7 | 683.6 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, D7 | 1816.1 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, D7 | 662.3 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, D7 | 13098.6 Titers |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, D7 | 7871.9 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, M3 | 5586.1 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, D7 | 605 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, M3 | 128.3 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, PRE | 11.5 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, D7 | 18262.1 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, M3 | 4451.3 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, PRE | 4.9 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, D7 | 295.6 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, M3 | 93.2 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, PRE | 70.7 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, D7 | 1971.4 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, M3 | 2536.9 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, PRE | 1368.2 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, D7 | 19243.4 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, M3 | 9692 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, PRE | 398.2 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, D7 | 8322.7 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, M3 | 6456.1 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, PRE | 586.5 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, D7 | 4678.2 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, M3 | 4891.1 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, PRE | 5.3 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, D7 | 2503.1 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, M3 | 2255.9 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, PRE | 12 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, D7 | 700.2 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, M3 | 1437.7 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, PRE | 176.4 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, D7 | 6813.9 Titers |
| Unprimed Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, PRE | 5 Titers |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).
Time frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 OPA Titers, Y1 | 16.2 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 OPA Titers, Y1 | 59.8 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 OPA Titers, Y1 | 24.2 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B OPA Titers, Y1 | 35.5 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F OPA Titers, Y1 | 1855.7 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V OPA Titers, Y1 | 791.5 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 OPA Titers, Y1 | 551.9 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C OPA Titers, Y1 | 23.5 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F OPA Titers, Y1 | 53.4 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F OPA Titers, Y1 | 784.9 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F OPA Titers, Y1 | 35.4 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 OPA Titers, Y1 | 4.8 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V OPA Titers, Y1 | 1240.7 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F OPA Titers, Y1 | 350.4 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 OPA Titers, Y1 | 192.9 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F OPA Titers, Y1 | 3013.1 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C OPA Titers, Y1 | 15.5 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 OPA Titers, Y1 | 5.1 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 OPA Titers, Y1 | 607.3 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B OPA Titers, Y1 | 476.9 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-18C OPA Titers, Y1 | 10.4 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-6B OPA Titers, Y1 | 44.7 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-7F OPA Titers, Y1 | 1617.2 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-9V OPA Titers, Y1 | 370.5 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-19F OPA Titers, Y1 | 58 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-14 OPA Titers, Y1 | 456.6 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-1 OPA Titers, Y1 | 7.3 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-23F OPA Titers, Y1 | 552.3 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-4 OPA Titers, Y1 | 88.9 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] | Anti-5 OPA Titers, Y1 | 11.2 Titer |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)]
Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).
Time frame: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 OPA Titers, Y2 | 8.4 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 OPA Titers, Y2 | 29 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 OPA Titers, Y2 | 11.4 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B OPA Titers, Y2 | 167.2 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F OPA Titers, Y2 | 1488.7 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V OPA Titers, Y2 | 648.5 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 OPA Titers, Y2 | 660.2 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C OPA Titers, Y2 | 34.9 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F OPA Titers, Y2 | 78.1 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F OPA Titers, Y2 | 632 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F OPA Titers, Y2 | 49.2 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 OPA Titers, Y2 | 4 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V OPA Titers, Y2 | 730.4 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F OPA Titers, Y2 | 1068.3 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 OPA Titers, Y2 | 33.5 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F OPA Titers, Y2 | 1923 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C OPA Titers, Y2 | 34.8 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 OPA Titers, Y2 | 4.3 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 OPA Titers, Y2 | 651 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B OPA Titers, Y2 | 526.1 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-18C OPA Titers, Y2 | 17.7 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-6B OPA Titers, Y2 | 213.7 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-7F OPA Titers, Y2 | 1387.8 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-9V OPA Titers, Y2 | 391 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-19F OPA Titers, Y2 | 105.4 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-14 OPA Titers, Y2 | 534.4 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-1 OPA Titers, Y2 | 6.3 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-23F OPA Titers, Y2 | 435 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-4 OPA Titers, Y2 | 39.3 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] | Anti-5 OPA Titers, Y2 | 7.4 Titer |
Secondary
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
Pneumococcal serotypes assessed were pneumococcal serotypes OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).
Time frame: At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT-007)
Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, Y4 | 8.8 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, Y4 | 37.9 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, Y4 | 7.7 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, Y4 | 875.7 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, Y4 | 1693.1 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, Y4 | 747.4 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, Y4 | 1139.8 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, Y4 | 46.4 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, Y4 | 151.7 Titer |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, Y4 | 1518.4 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, Y4 | 178.8 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, Y4 | 4.6 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, Y4 | 563.8 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, Y4 | 965.8 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, Y4 | 62.2 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, Y4 | 3366.1 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, Y4 | 35.3 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, Y4 | 5.3 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, Y4 | 687.9 Titer |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, Y4 | 978.3 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-18C OPA Titers, Y4 | 26.6 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-6B OPA Titers, Y4 | 716.4 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-7F OPA Titers, Y4 | 1602.1 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-9V OPA Titers, Y4 | 558.6 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-19F OPA Titers, Y4 | 129.3 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-14 OPA Titers, Y4 | 849.4 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-1 OPA Titers, Y4 | 8.9 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-23F OPA Titers, Y4 | 1146.2 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-4 OPA Titers, Y4 | 50.7 Titer |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] | Anti-5 OPA Titers, Y4 | 5.5 Titer |