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Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

Primary Purpose

Infections, Streptococcal

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pneumococcal conjugate vaccine GSK1024850A

About this trial

This is an interventional prevention trial for Infections, Streptococcal focused on measuring Pneumococcal vaccine, Pneumococcal disease, Safety, Immunogenicity

Eligibility Criteria

36 Months - 46 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female between, and including, +- 36-46 months of age at the time of vaccination.
For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/guardian(s) 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 vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
For unprimed subjects: previous vaccination with any pneumococcal vaccine.
Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
Acute disease at the time of enrolment.

Sites / Locations

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

Experimental

Active Comparator

Arm Label

Synflorix™ Group 1

Synflorix™ Group 2

Unprimed Group

Arm Description

Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.

Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.

Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.

Outcomes

Primary Outcome Measures

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Antibodies assessed were those against the vaccine 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2

Secondary Outcome Measures

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Antibodies assessed for this outcome measure were those against the vaccine 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). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.2 μg/mL.

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2

Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and19A (ANTI-6A and19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2

Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group

Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2

ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.

Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group

Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2

Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to and 7-10 days post- additional dose.

Number of Subjects With B-cells Detection in the Unprimed Group

Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post-dose 1.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed local symptoms were pain, redness and swelling. Any = occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = crying when limb was moved/ spontaneously painful. Grade 3 Redness/ Swelling = Redness/ swelling at injection site greater than (>) 30 millimeters (mm).

Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, irritability/ fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and Fever (rectal temperature ≥ 38.0 °C). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 drowsiness = drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = crying that could not be comforted/ prevented normal everyday activities. Grade 3 loss of appetite = not eating at all. Grade 3 fever = rectal temperature > 40.0°C.

Number (%) of Subjects With Unsolicited Adverse Events

An unsolicited AE was defined as 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 = occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

Number (%) of Subjects With Serious Adverse Events

A serious adverse event (SAE) was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = occurrence of a SAE, regardless of relationship to vaccination.

Full Information

NCT ID

NCT00792909

First Posted

November 17, 2008

Last Updated

May 12, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00792909

Brief Title

Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

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

May 2017

Overall Recruitment Status

Completed

Study Start Date

December 2, 2008 (Actual)

Primary Completion Date

July 2, 2009 (Actual)

Study Completion Date

July 2, 2009 (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 study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children. The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life. The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life. 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 = 00307034)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Streptococcal

Keywords

Pneumococcal vaccine, Pneumococcal disease, Safety, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Synflorix™ Group 1

Arm Type

Experimental

Arm Description

Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.

Arm Title

Synflorix™ Group 2

Arm Type

Experimental

Arm Description

Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.

Arm Title

Unprimed Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Pneumococcal conjugate vaccine GSK1024850A

Intervention Description

Intramuscular injection, 1 dose

Intervention Type

Biological

Intervention Name(s)

Pneumococcal conjugate vaccine GSK1024850A

Intervention Description

Intramuscular injection, 2 doses

Primary Outcome Measure Information:

Title

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Description

Time Frame

Pre-vaccination (PRE/ Day 0)

Title

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Description

Time Frame

One week after dose 1 (Day 7)

Title

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Description

Time Frame

One month after dose 2 (Month 3)

Title

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2

Description

Time Frame

1 month after booster dose (Month 10) - in primary study (105539)

Title

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2

Description

Time Frame

Pre-additional dose at Month 34 in the current study (Month 34)

Title

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2

Description

Time Frame

One week after vaccination at Month 34+7 days (Mth34+D7)

Secondary Outcome Measure Information:

Title

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Description

Time Frame

1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+ D7);

Title

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;

Description

Time Frame

Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);

Title

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Description

Time Frame

1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Title

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group

Description

Time Frame

Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);

Title

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2

Description

Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Time Frame

1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Title

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Description

Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Time Frame

Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Title

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2

Description

Time Frame

1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Title

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group

Description

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time Frame

Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Title

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Description

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time Frame

1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Title

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group

Description

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Time Frame

Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Title

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;

Description

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.

Time Frame

1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7);

Title

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group

Description

Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.

Time Frame

Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Title

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2

Description

Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8

Time Frame

1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Title

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group

Description

Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.

Time Frame

Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Title

Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2

Description

Time Frame

1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Title

Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group

Description

Time Frame

Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Title

Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2

Description

Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to and 7-10 days post- additional dose.

Time Frame

Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Title

Number of Subjects With B-cells Detection in the Unprimed Group

Description

Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post-dose 1.

Time Frame

Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Description

Time Frame

During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group1 and the Synflorix Group2 and across the 2 doses in the Unprimed Group

Title

Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.

Title

Number (%) of Subjects With Unsolicited Adverse Events

Description

Time Frame

Within the 31-day (Days 0-30) period post vaccination, with the Synflorix™ vaccine, following the additional dose in the Synflorix group1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group

Title

Number (%) of Subjects With Serious Adverse Events

Description

Time Frame

During the 31-day period following vaccination period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

36 Months

Maximum Age & Unit of Time

46 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female between, and including, +- 36-46 months of age at the time of vaccination. For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034). Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol. Written informed consent obtained from the parent(s)/guardian(s) 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 vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination. For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034). For unprimed subjects: previous vaccination with any pneumococcal vaccine. Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine. Acute disease at the time of enrolment.

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

Dlha nad Oravou

ZIP/Postal Code

027 55

Country

Slovakia

Facility Name

GSK Investigational Site

City

Dolny Kubin

ZIP/Postal Code

026 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Ruzomberok

ZIP/Postal Code

034 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Umeå

ZIP/Postal Code

SE-901 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Örebro

ZIP/Postal Code

SE-701 16

Country

Sweden

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

21572373

Citation

Silfverdal SA, Skerlikova H, Zanova M, Papuchova D, Traskine M, Borys D, Schuerman L. Anamnestic immune response in 3- to 4-year-old children previously immunized with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine as 2-dose or 3-dose priming and a booster dose in the first year of life. Pediatr Infect Dis J. 2011 Sep;30(9):e155-63. doi: 10.1097/INF.0b013e31821feeb7.

Results Reference

background

Citation

Silfverdal SA et al. Assessment of immunological memory following PHiD-CV immunisation according to 2+1 or 3+1 schedules in the first year of life. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Results Reference

background

Citation

Silfverdal SA et al. Immunogenicity/reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) during fourth year of life. Abstract presented at the 8th Biennial International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Foz de Iguaçu, Brazil, 11-15 March 2012.

Results Reference

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Links:

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https://www.clinicalstudydatarequest.com

Description

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Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

111736

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

111736

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

111736

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

111736

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

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Available IPD/Information Identifier

111736

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

111736

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

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