Infections, StreptococcalPhase 3NCT00792909

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

A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A in people with Infections, Streptococcal, run by GlaxoSmithKline at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 36 to 46 monthsHealthy volunteers can take part
Conditions the study is for: Infections, Streptococcal
What is being tested?: Pneumococcal conjugate vaccine GSK1024850A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 172 participants
Where: 5 sitesin 2 countries
Study dates: 2 Dec 2008to 2 Jul 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 36 to 46 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Slovakia3 sites

GSK Investigational Site
Dlhá nad Oravou, 027 55
GSK Investigational Site
Dolný Kubín, 026 01
GSK Investigational Site
Ružomberok, 034 01

Other trials in Slovakia

Sweden2 sites

GSK Investigational Site
Örebro, SE-701 16
GSK Investigational Site
Umeå, SE-901 85

Other trials in Sweden

About this study

Official title: Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and 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)

Conditions: Infections, Streptococcal
Being tested: Pneumococcal conjugate vaccine GSK1024850A
Keywords: Pneumococcal vaccine, Pneumococcal disease, Safety, Immunogenicity
Medical subject headings: Streptococcal Infections, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumococcal conjugate vaccine GSK1024850ABiological
Intramuscular injection, 1 dose
Pneumococcal conjugate vaccine GSK1024850ABiological
Intramuscular injection, 2 doses

Study groups in NCT00792909
Study group	Role	What they receive
Synflorix™ Group 1	Experimental	Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age. Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A
Synflorix™ Group 2	Experimental	Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age. Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A
Unprimed Group	Active comparator	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. Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Pre-vaccination (PRE/ Day 0)
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 ≥ 0.05 μg/mL.
Measured: One week after dose 1 (Day 7)
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 ≥ 0.05 μg/mL.
Measured: One month after dose 2 (Month 3)
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
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 ≥ 0.05 μg/mL.
Measured: 1 month after booster dose (Month 10) - in primary study (105539)
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
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 ≥ 0.05 μg/mL.
Measured: Pre-additional dose at Month 34 in the current study (Month 34)
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
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 ≥ 0.05 μg/mL.
Measured: One week after vaccination at Month 34+7 days (Mth34+D7)

Secondary outcomes (22)

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 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 ≥ 0.05 μg/mL..
Measured: 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);
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;
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 ≥ 0.05 μg/mL.
Measured: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);
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.
Measured: 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)
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
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 ≥ 0.20 μg/mL.
Measured: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);
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.
Measured: 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)
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.
Measured: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
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.
Measured: 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)
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.
Measured: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
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.
Measured: 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)
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.
Measured: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
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.
Measured: 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);
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.
Measured: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
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
Measured: 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)
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.
Measured: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
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.
Measured: 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)
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group
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.
Measured: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
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.
Measured: Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)
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.
Measured: Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)
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).
Measured: 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
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.
Measured: 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.
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.
Measured: 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
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.
Measured: During the 31-day period following vaccination period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 20082 Jul 2009

First posted18 Nov 2008 (estimated)
Study start2 Dec 2008
Primary completion2 Jul 2009
Study completion2 Jul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00792909
Sponsor's protocol ID: 111736
Status last verified: May 2017
First submitted: 17 Nov 2008
Last updated: 14 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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.
PubMed 21572373
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.
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children
ClinicalTrials.gov ID: NCT00792909
Acronym / sponsor ID: 111736
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine, Pneumococcal disease, Safety, Immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 2 Dec 2008 (actual)
Primary completion: 2 Jul 2009 (actual)
Study completion: 2 Jul 2009 (actual)
First posted: 18 Nov 2008 (estimated)
Results: Posted 14 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Synflorix™ Group 1	Experimental	Biological: Pneumococcal conjugate vaccine GSK1024850ASubjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Synflorix™ Group 2	Experimental	Biological: Pneumococcal conjugate vaccine GSK1024850ASubjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Unprimed Group	Active comparator	Biological: Pneumococcal conjugate vaccine GSK1024850AAge-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.

Who may qualify

Ages: 36 to 46 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pneumococcal conjugate vaccine GSK1024850AIntramuscular injection, 1 dose	Biological	Synflorix™ Group 1, Synflorix™ Group 2
Pneumococcal conjugate vaccine GSK1024850AIntramuscular injection, 2 doses	Biological	Unprimed Group

Primary outcome

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
Time frame: Pre-vaccination (PRE/ Day 0)
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
Time frame: One week after dose 1 (Day 7)
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 ≥ 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
Time frame: One month after dose 2 (Month 3)
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 ≥ 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 Synflorix Group 1 and Synflorix Group 2
Time frame: 1 month after booster dose (Month 10) - in primary study (105539)
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 ≥ 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 Synflorix Group 1 and Synflorix Group 2
Time frame: Pre-additional dose at Month 34 in the current study (Month 34)
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 ≥ 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 Synflorix Group 1 and Synflorix Group 2
Time frame: One week after vaccination at Month 34+7 days (Mth34+D7)
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 ≥ 0.05 μg/mL.

22 secondary outcomes

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
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);
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;
Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);
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
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)
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
Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);
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
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)
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
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)
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
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)
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;
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);
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group
Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
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)
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2
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)
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group
Time frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
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)
Number of Subjects With B-cells Detection in the Unprimed Group
Time frame: Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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.
Number (%) of Subjects With Unsolicited Adverse Events
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
Number (%) of Subjects With Serious Adverse Events
Time frame: During the 31-day period following vaccination period

Results and safety

Results posted to the registry on 14 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Synflorix™ Group 1	51	51
Synflorix™ Group 2	59	58
Unprimed Group	62	62

Primary outcome: 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

Time frame: Pre-vaccination (PRE/ Day 0). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Unprimed Group n = 60
Anti-1 at PRE	0.06 (0.05 to 0.08)
Anti-4 at PRE	0.04 (0.03 to 0.05)
Anti-5 at PRE	0.07 (0.05 to 0.09)
Anti-6B at PRE	0.1 (0.07 to 0.13)
Anti-7F at PRE	0.08 (0.05 to 0.12)
Anti-9V at PRE	0.05 (0.04 to 0.07)
Anti-14 at PRE	0.25 (0.16 to 0.38)
Anti-18C at PRE	0.06 (0.04 to 0.08)

Population analysed: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.

Primary outcome: 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

Time frame: One week after dose 1 (Day 7). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Unprimed Group n = 60
Anti-1 at Day 7	0.6 (0.47 to 0.76)
Anti-4 at Day 7	2.37 (1.91 to 2.94)
Anti-5 at Day 7	0.45 (0.34 to 0.59)
Anti-6B at Day 7	0.2 (0.14 to 0.29)
Anti-7F at Day 7	0.92 (0.67 to 1.25)
Anti-9V at Day 7	0.33 (0.23 to 0.48)
Anti-14 at Day 7	0.54 (0.34 to 0.86)
Anti-18C at Day 7	1.45 (1.01 to 2.06)

Primary outcome: 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

Time frame: One month after dose 2 (Month 3). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Unprimed Group n = 60
Anti-1 at Month 3	2.81 (2.25 to 3.51)
Anti-4 at Month 3	8.44 (7.16 to 9.94)
Anti-5 at Month 3	3.54 (2.96 to 4.23)
Anti-6B at Month 3	1.11 (0.84 to 1.46)
Anti-7F at Month 3	6.1 (4.99 to 7.46)
Anti-9V at Month 3	2.22 (1.74 to 2.82)
Anti-14 at Month 3	6.48 (4.98 to 8.44)
Anti-18C at Month 3	22.28 (18.14 to 27.36)

Primary outcome: 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

Time frame: 1 month after booster dose (Month 10) - in primary study (105539). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Synflorix™ Group 1 n = 50	Synflorix™ Group 2 n = 57
Anti-1 at Month 10	1.91 (1.52 to 2.42)	1.87 (1.49 to 2.33)
Anti-4 at Month 10	2.97 (2.34 to 3.77)	3.2 (2.62 to 3.91)
Anti-5 at Month 10	2.71 (2.15 to 3.41)	3.01 (2.4 to 3.76)
Anti-6B at Month 10	0.9 (0.59 to 1.36)	1.62 (1.16 to 2.27)
Anti-7F at Month 10	2.94 (2.4 to 3.59)	3.88 (3.23 to 4.65)
Anti-9V at Month 10	2.59 (2.03 to 3.31)	3.81 (3.11 to 4.67)
Anti-14 at Month 10	3.91 (3.05 to 5)	5.22 (4.22 to 6.46)
Anti-18C at Month 10	4.87 (3.77 to 6.29)	5.52 (4.2 to 7.26)

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synflorix™ Group 1	1 of 51 (2%)	41 of 51 (80.4%)	1 of 51
Synflorix™ Group 2	1 of 59 (1.7%)	44 of 59 (74.6%)	1 of 59
Unprimed Group	1 of 62 (1.6%)	49 of 62 (79%)	1 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21572373Silfverdal 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.
BackgroundSilfverdal 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.
BackgroundSilfverdal 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A in people with Infections, Streptococcal, run by GlaxoSmithKline at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Slovakia, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Pre-vaccination (PRE/ Day 0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00792909, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.