Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine

Long-term Follow-up Study to Assess Antibody Persistence in Children Previously Vaccinated With Four Doses of Pneumococcal Conjugate Vaccine in Primary Vaccination Study (105553) and Booster Vaccination Study (107046)

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).

Study Overview

• Status: Completed
• Conditions: Streptococcus Pneumoniae Vaccines; Infections, Streptococcal
• Intervention / Treatment: Biological: GSK1024805A; Biological: Infanrix hexa; Biological: Havrix; Biological: Varilrix; Biological: Prevenar

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.

• Study Type: Interventional
• Enrollment (Actual): 524
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland, 85-021
    • GSK Investigational Site
  • Debica, Poland, 39-200
    • GSK Investigational Site
  • Krakow, Poland, 31-503
    • GSK Investigational Site
  • Olesnica, Poland, 56-400
    • GSK Investigational Site
  • Poznan, Poland, 61-709
    • GSK Investigational Site
  • Siemianowice Slaskie, Poland, 41-103
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Biological: GSK1024805A; No vaccination in this trial; Other Names: Synflorix; Biological: Infanrix hexa; No vaccination in this trial; Biological: Havrix; No vaccination in this trial; Biological: Varilrix; No vaccination in this trial
Active Comparator: 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).	Biological: Infanrix hexa; No vaccination in this trial; Biological: Havrix; No vaccination in this trial; Biological: Varilrix; No vaccination in this trial; Biological: Prevenar; No vaccination in this trial
Experimental: 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).	Biological: GSK1024805A; No vaccination in this trial; Other Names: Synflorix; Biological: Infanrix hexa; No vaccination in this trial; Biological: Havrix; No vaccination in this trial; Biological: Varilrix; No vaccination in this trial; Biological: Prevenar; No vaccination in this trial
Experimental: 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.	Biological: GSK1024805A; No vaccination in this trial; Other Names: Synflorix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007)
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.	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 (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).	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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).	At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)
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).	At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT-007)
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).	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 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).	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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).	At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PDDIT- 007)
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.	At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT- 007)
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.	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 (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).	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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).	At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)
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).	At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
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).	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 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.	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT- 007)
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.	At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT- 007)
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.	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)
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.	Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study
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.	Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study
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.	Within 31 days (Day 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study
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.	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)
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.	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))
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.	For primed groups: from Months 48-49 (additional vaccination period); for unprimed group: from Day 0 up to Month 3 (catch-up vaccination period)
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.	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	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)
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.	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	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)
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.	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	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)
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.	At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)
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.	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)
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.	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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2008
• Primary Completion (Actual): June 2, 2008
• Study Completion (Actual): June 2, 2008

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pneumococcal conjugate vaccine; Antibody persistence; Streptococcus pneumoniae; Haemophilus influenzae
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 111345 (Mth 12); 111346 (Mth 24) (Other Identifier: GSK); 111347 (Mth 48) (Other Identifier: GSK); 2007-005392-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Study Protocol
   Information identifier: 111345 (Mth 12)
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 111345 (Mth 12)
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 111345 (Mth 12)
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 111345 (Mth 12)
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 111345 (Mth 12)
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 111345 (Mth 12)
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register