Back to resultsLong-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Primary Purpose
Infections, Streptococcal
Status
Completed
Phase
Phase 3
Locations
Czechia
Study Type
Interventional
Intervention
Pneumococcal vaccine GSK1024850A
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Streptococcal focused on measuring Catch-up vaccination, Pneumococcal vaccine, Immune memory, Nasopharyngeal carriage, Immunogenicity, Pneumococcal disease, Safety
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
- Subjects who previously participated in study NCT00496015
- For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
- For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
- Written informed consent 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:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of seizures or progressive neurological disease.
- Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
- Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
- Administration of any pneumococcal vaccine since the end of study NCT00496015.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
AP-AP Group
NAP-pre Group
Unprimed Group
Arm Description
subjects from the AP-AP group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015, receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment
subjects from the NAP-pre group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015 receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment
Age-matched subjects from the unprimed group of the NCT00496015 study, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A
Outcomes
Primary Outcome Measures
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.
Secondary Outcome Measures
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition ELISA, presented as GMCs and expressed in μg/mL. The seropositivity cut-off value of the assay was an antibody concentration ≥ 0.05 μg/mL.
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).
Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A
The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).
Antibody Concentrations Against Protein D (Anti-PD)
Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.
Memory B-cell Detection for Vaccine Polysaccharides (PS)
B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population.
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).
Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A
The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).
Antibody Concentrations Against Protein D (Anti-PD)
Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.
Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)
The Neisseria meningitidis serogroups assessed using rabbit complement were: A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY), presented as geometric mean titers (GMTs). The seropositivity cut-off of the assay was an antibody titer ≥ 8.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the primed groups.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the unprimed group.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the primed groups.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the unprimed group.
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)
Positive cultures of S. pneumoniae Synflorix™ vaccine serotypes identified in the nasopharynx were recorded.
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
Positive cultures of S. pneumoniae cross- reactive serotypes identified in the nasopharynx were recorded.
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
Positive cultures of S. pneumoniae non- Synflorix™ vaccine, non-cross-reactive serotypes identified in the nasopharynx were recorded.
Number of Nasopharyngeal Swabs With Haemophilus Influenzae
Positive cultures of H. influenzae identified in the nasopharynx were recorded.
Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs
The number of subjects with new acquisition of S. pneumoniae (Synflorix™ vaccine serotypes) detected in nasopharyngeal swabs was recorded.
Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs
The number of subjects with new acquisition of S. pneumoniae (cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.
Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs
The number of subjects with new acquisition of S. pneumoniae (non-vaccine and non-cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.
Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs
The number of subjects with new acquisition of H. influenzae detected in nasopharyngeal swabs was recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00950833
Brief Title
Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Official Title
Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2009 (Actual)
Primary Completion Date
September 16, 2010 (Actual)
Study Completion Date
October 27, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
This protocol posting deals with objectives & outcome measures of the extension phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).
Detailed Description
This protocol posting has been updated according to Protocol Amendment 1, July 2009
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal
Keywords
Catch-up vaccination, Pneumococcal vaccine, Immune memory, Nasopharyngeal carriage, Immunogenicity, Pneumococcal disease, Safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
466 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AP-AP Group
Arm Type
Active Comparator
Arm Description
subjects from the AP-AP group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015, receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment
Arm Title
NAP-pre Group
Arm Type
Active Comparator
Arm Description
subjects from the NAP-pre group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015 receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment
Arm Title
Unprimed Group
Arm Type
Active Comparator
Arm Description
Age-matched subjects from the unprimed group of the NCT00496015 study, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine GSK1024850A
Intervention Description
1 or 2 intramuscular injections
Primary Outcome Measure Information:
Title
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Description
Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.
Time Frame
At 7-10 days after the first vaccine dose
Secondary Outcome Measure Information:
Title
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Description
Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition ELISA, presented as GMCs and expressed in μg/mL. The seropositivity cut-off value of the assay was an antibody concentration ≥ 0.05 μg/mL.
Time Frame
Prior to the first study vaccine dose (At Day 0)
Title
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
Description
Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).
Time Frame
Prior to (Day 0) and 7-10 days after the first vaccine dose
Title
Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A
Description
The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Time Frame
Prior to (Day 0) and 7-10 days after the first vaccine dose
Title
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Description
Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).
Time Frame
Prior to (Day 0) and 7-10 days after the first vaccine dose
Title
Antibody Concentrations Against Protein D (Anti-PD)
Description
Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.
Time Frame
Prior to (Day 0) and 7-10 days after the first vaccine dose
Title
Memory B-cell Detection for Vaccine Polysaccharides (PS)
Description
B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population.
Time Frame
Prior to (Day 0) and 7-10 days after the first vaccine dose
Title
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Description
The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Time Frame
At Month 12, one month after the second vaccine dose
Title
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
Description
Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).
Time Frame
At Month 12, one month after the second vaccine dose
Title
Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A
Description
The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Time Frame
At Month 12, one month after the second vaccine dose
Title
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Description
Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).
Time Frame
At Month 12, one month after the second vaccine dose
Title
Antibody Concentrations Against Protein D (Anti-PD)
Description
Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.
Time Frame
At Month 12, one month after the second vaccine dose
Title
Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)
Description
The Neisseria meningitidis serogroups assessed using rabbit complement were: A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY), presented as geometric mean titers (GMTs). The seropositivity cut-off of the assay was an antibody titer ≥ 8.
Time Frame
At 25-36 months post-vaccination in previous 107137 (NCT00496015) study
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the primed groups.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the unprimed group.
Time Frame
During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the primed groups.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the unprimed group.
Time Frame
During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame
Within 31 days (Days 0-30) after each vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
During the entire study period (from Day 0 up to Month 10 or Month 12)
Title
Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)
Description
Positive cultures of S. pneumoniae Synflorix™ vaccine serotypes identified in the nasopharynx were recorded.
Time Frame
At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
Title
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
Description
Positive cultures of S. pneumoniae cross- reactive serotypes identified in the nasopharynx were recorded.
Time Frame
At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
Title
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
Description
Positive cultures of S. pneumoniae non- Synflorix™ vaccine, non-cross-reactive serotypes identified in the nasopharynx were recorded.
Time Frame
At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
Title
Number of Nasopharyngeal Swabs With Haemophilus Influenzae
Description
Positive cultures of H. influenzae identified in the nasopharynx were recorded.
Time Frame
At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
Title
Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs
Description
The number of subjects with new acquisition of S. pneumoniae (Synflorix™ vaccine serotypes) detected in nasopharyngeal swabs was recorded.
Time Frame
At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
Title
Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs
Description
The number of subjects with new acquisition of S. pneumoniae (cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.
Time Frame
At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
Title
Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs
Description
The number of subjects with new acquisition of S. pneumoniae (non-vaccine and non-cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.
Time Frame
At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
Title
Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs
Description
The number of subjects with new acquisition of H. influenzae detected in nasopharyngeal swabs was recorded.
Time Frame
At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
31 Months
Maximum Age & Unit of Time
44 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
Subjects who previously participated in study NCT00496015
For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
Written informed consent 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:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of seizures or progressive neurological disease.
Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
Administration of any pneumococcal vaccine since the end of study NCT00496015.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
628 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
70800
Country
Czechia
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Znojmo
ZIP/Postal Code
669 00
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
23391599
Citation
Prymula R, Habib A, Francois N, Borys D, Schuerman L. Immunological memory and nasopharyngeal carriage in 4-year-old children previously primed and boosted with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with or without concomitant prophylactic paracetamol. Vaccine. 2013 Apr 12;31(16):2080-8. doi: 10.1016/j.vaccine.2013.01.044. Epub 2013 Feb 5.
Results Reference
background
Citation
Prymula R et al. Immune memory 2-3 years after vaccination with pneumococcal non-typeable Heamophilus influenzae protein-D conjugate vaccine (PHiD-CV), with or without prophylactic paracetamol. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.
Results Reference
background
Citation
Prymula R et al. Long-term effect of 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) on nasopharyngeal bacterial carriage in Czech children. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.
Results Reference
background
Citation
Silfverdal SA et al. Immunogenicity and reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) during the fourth year of life. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112801
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112801
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112801
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112801
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112801
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112801
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112801
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
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