Back to resultsPneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
Primary Purpose
Infections, Streptococcal
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Synflorix
Tritanrix-HepB
Hiberix
Polio Sabin
Poliorix
Prevenar (Wyeth)
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Streptococcal focused on measuring Booster vaccination., Immunogenicity, Pneumococcal vaccine, Safety, Pneumococcal disease
Eligibility Criteria
Inclusion Criteria:
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 and received three doses of pneumococcal conjugate vaccine.
- 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:
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit.
- Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007.
- History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
- Acute disease at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
Sites / Locations
- 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 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group
Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group
Arm Description
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age.
Outcomes
Primary Outcome Measures
Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off
Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever > 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.
Secondary Outcome Measures
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed included pain, redness and swelling. "Any" was defined as incidence of the specified symptom regardless of intensity. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm).
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature greater than or equal to (≥) 38.0°C), irritability, and loss of appetite."Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) >40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all.
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.
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 Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
The cut-off was 0.20 microgram per milliliter (μg/mL).
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations
Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.
Antibody Concentrations to Protein D (Anti-PD)
Seropositivity status, defined as anti-PD antibody concentrations ≥100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
The cut-off of the assay was 0.05 μg/mL.
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
The cut-off for the assay was 8.
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
The cut-of for the assay was 0.05 μg/mL.
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off
The cut-off for the assay was 8.
Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off
The cut-off for the assay was 100 ELISA units per milliliter (EL.U/mL).
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
Seroprotection status, defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
Anti-Bordetella Pertussis (BPT) Antibody Concentrations
Seropositivity status, defined as anti-BPT antibody concentrations ≥ 15 EL.U/mL.
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Seroprotection status, defined as anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL).
Anti-polio Type 1, 2 and 3 Antibody Titers
Seroprotection status, defined as anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers ≥ 8.
Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off
The cut-off for the assay was 15 EL.U/mL.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off
The cut-off for the assay was 0.1 milli-international units per milliliter (mIU/mL).
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
The cut-off for the assay was 0.15 μg/mL.
Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off
The cut-off for the assay was 1.0 μg/mL.
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off
The cut-off for the assay was 10 mIU/mL.
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off
The cut-off for the assay was 8.
Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)
Vaccine response for anti-BPT, defined as the appearance of antibodies in subjects seronegative at pre-vaccination, or at least 2-fold increase of pre-vaccination antibody concentrations in those who were initially seropositive at pre-vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00547248
Brief Title
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
Official Title
Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 22, 2007 (Actual)
Primary Completion Date
May 10, 2008 (Actual)
Study Completion Date
October 7, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal
Keywords
Booster vaccination., Immunogenicity, Pneumococcal vaccine, Safety, Pneumococcal disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
756 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group
Arm Type
Experimental
Arm Description
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
Arm Title
Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group
Arm Type
Active Comparator
Arm Description
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
Arm Title
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group
Arm Type
Experimental
Arm Description
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
Arm Title
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group
Arm Type
Active Comparator
Arm Description
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age.
Intervention Type
Biological
Intervention Name(s)
Synflorix
Other Intervention Name(s)
Pneumococcal conjugate vaccine GSK1024850A
Intervention Description
Intramuscular injection, 1 dose
Intervention Type
Biological
Intervention Name(s)
Tritanrix-HepB
Other Intervention Name(s)
DTPw-HBV vaccine
Intervention Description
Intramuscular injection, 1 dose
Intervention Type
Biological
Intervention Name(s)
Hiberix
Other Intervention Name(s)
Hib vaccine
Intervention Description
Reconstituted with Tritanrix-Hep B before injection
Intervention Type
Biological
Intervention Name(s)
Polio Sabin
Other Intervention Name(s)
OPV
Intervention Description
Oral, 1 dose
Intervention Type
Biological
Intervention Name(s)
Poliorix
Other Intervention Name(s)
IPV
Intervention Description
Intramuscular injection, 1 dose
Intervention Type
Biological
Intervention Name(s)
Prevenar (Wyeth)
Other Intervention Name(s)
Pneumococcal conjugate vaccine
Intervention Description
Intramuscular injection, 1 dose
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off
Description
Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever > 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.
Time Frame
Within the 4-day (Days 0-3) period after booster vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Solicited local symptoms assessed included pain, redness and swelling. "Any" was defined as incidence of the specified symptom regardless of intensity. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm).
Time Frame
Within the 4-day (Days 0-3) period after booster vaccination
Title
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Description
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature greater than or equal to (≥) 38.0°C), irritability, and loss of appetite."Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) >40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all.
Time Frame
Within the 4-day (Days 0-3) period after booster vaccination
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
Within the 31-day (Days 0-30) period after booster 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
Throughout the active phase of the study (Month 0 to Month 1)
Title
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
Description
The cut-off was 0.20 microgram per milliliter (μg/mL).
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations
Description
Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Description
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Antibody Concentrations to Protein D (Anti-PD)
Description
Seropositivity status, defined as anti-PD antibody concentrations ≥100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Description
Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Description
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
Description
The cut-off of the assay was 0.05 μg/mL.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Description
The cut-off for the assay was 8.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
Description
The cut-of for the assay was 0.05 μg/mL.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off
Description
The cut-off for the assay was 8.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off
Description
The cut-off for the assay was 100 ELISA units per milliliter (EL.U/mL).
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Description
Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
Description
Seroprotection status, defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Anti-Bordetella Pertussis (BPT) Antibody Concentrations
Description
Seropositivity status, defined as anti-BPT antibody concentrations ≥ 15 EL.U/mL.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Description
Seroprotection status, defined as anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL).
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Anti-polio Type 1, 2 and 3 Antibody Titers
Description
Seroprotection status, defined as anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers ≥ 8.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off
Description
The cut-off for the assay was 15 EL.U/mL.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off
Description
The cut-off for the assay was 0.1 milli-international units per milliliter (mIU/mL).
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
Description
The cut-off for the assay was 0.15 μg/mL.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off
Description
The cut-off for the assay was 1.0 μg/mL.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off
Description
The cut-off for the assay was 10 mIU/mL.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off
Description
The cut-off for the assay was 8.
Time Frame
Prior to (Month 0) and one month after booster vaccination (Month 1)
Title
Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)
Description
Vaccine response for anti-BPT, defined as the appearance of antibodies in subjects seronegative at pre-vaccination, or at least 2-fold increase of pre-vaccination antibody concentrations in those who were initially seropositive at pre-vaccination.
Time Frame
One month after booster vaccination (Month 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 and received three doses of pneumococcal conjugate vaccine.
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:
Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit.
Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007.
History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
Acute disease at the time of enrolment.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
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
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
80-394
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
GSK Investigational Site
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
GSK Investigational Site
City
Tuchola
ZIP/Postal Code
89-500
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
50345
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
52-312
Country
Poland
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
20980933
Citation
Bermal N, Szenborn L, Edison A, Hernandez M, Pejcz J, Majda-Stanislawska E, Gatchalian S, Fanic A, Dieussaert I, Schuerman L. Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with DTPw-HBV/Hib and poliovirus vaccines. Pediatr Infect Dis J. 2011 Jan;30(1):69-72. doi: 10.1097/INF.0b013e3181f2da06.
Results Reference
background
Citation
Bermal N et al. Primary and booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib and polio vaccines. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
background
Citation
Nancy B et al. Booster dose of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) administered to children in the Philippines: antibody responses and safety. Abstract presented at the 13th Asian Pacific Congress of Pediatrics (APCP). Shanghai, China, 14-18 October 2009.
Results Reference
background
Citation
Schuerman L et al. Immune responses against cross-reactive pneumococcal serotypes 6A and 19A with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
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Citation
Schuerman L et al. Immune responses to the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) appear not influenced by co-administration with DTPw-combination vaccine. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
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109509
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Learn more about this trial
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
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