Infections, StreptococcalPhase 3NCT00985465
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
A Phase 3 study testing Pneumococcal vaccine GSK1024850A in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Mali.
Trial summary
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary… Read more about this study
- Who is it for?
- Ages 15 to 21 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Pneumococcal vaccine GSK1024850A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteMali
- Study dates
- 12 Nov 2009to 26 Jul 2010
- 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 15 to 21 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- A male or female, between and including 15-21 months of age at the time of visit 1.
- For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
- Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Healthy subjects 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 vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
- Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Administration of any pneumococcal vaccine since the end of study NCT00678301.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
Show all 12Show fewer
- Major congenital defects or serious chronic illness.
- History of any progressive neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
- Child in care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine GSK1024850A, Given Either as a Booster Dose or as a 2-dose Catch-up Immunization in Healthy Malian Children
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301.
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 = NCT00678301).
- Conditions
- Infections, Streptococcal
- Being tested
- Pneumococcal vaccine GSK1024850A
- Keywords
- Booster vaccination, Pneumococcal vaccine, Catch-up vaccination, 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 vaccine GSK1024850ABiological
Intramuscular injection, 1 or 2 doses
| Study group | Role | What they receive |
|---|---|---|
| Pn-Pn group | Experimental | subjects from the Pn-Pn group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in the Malian centre of study NCT00678301, receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A Receives: Biological: Pneumococcal vaccine GSK1024850A |
| Zil-Pn group | Experimental | subjects from the unprimed group of the NCT00678301 Malian study centre, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A Receives: Biological: Pneumococcal vaccine GSK1024850A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)
The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.
Measured: Within 31 days (Day 0-Day 30) after booster vaccination
Secondary outcomes (11)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: Within 4 days (Day 0-Day 3) after the booster dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Within 4 days (Day 0-Day 3) after the booster dose
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: Within 4 days (Day 0-Day 3) after each vaccine dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Within 4 days (Day 0-Day 3) after each vaccine dose
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: Within 31 days (Day 0-Day 30) after each vaccine dose
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.
Measured: From the first vaccination up to one month (31 days) after the last vaccination for each subject
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). Pneumococcal serotype specific total immunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL.
Measured: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.
Measured: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL.
Measured: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and Opsono-19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.
Measured: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Concentrations of Antibodies Against Protein D (PD)
Concentrations of antibodies against protein D (PD) were determined by ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is ≥ 100 ELISA units per milliliter (EL.U/mL).
Measured: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study start12 Nov 2009
- Primary completion26 Jun 2010
- Study completion26 Jul 2010
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 (4)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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985465
- Sponsor's protocol ID
- 113166
- Status last verified
- Jul 2018
- First submitted
- 24 Sep 2009
- Last updated
- 14 Dec 2018
- 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
Dicko A, Santara G, Mahamar A, Sidibe Y, Barry A, Dicko Y, Diallo A, Dolo A, Doumbo O, Shafi F, Francois N, Strezova A, Borys D, Schuerman L. Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Hum Vaccin Immunother. 2013 Feb;9(2):382-8. doi: 10.4161/hv.22692. Epub 2013 Jan 4.
PubMed 23291945Dicko A et al. Safety and immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Abstract presented at the 7th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011 (Abstract 532).
Dicko et al. Safety/reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) in Malian children. Abstract presented at the 8th International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March 2012 (Abstract 085).
Dicko A, Dicko Y, Barry A, Sidibe Y, Mahamar A, Santara G, Dolo A, Diallo A, Doumbo O, Shafi F, Francois N, Yarzabal JP, Strezova A, Borys D, Schuerman L. Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study. Hum Vaccin Immunother. 2015;11(9):2207-14. doi: 10.1080/21645515.2015.1016679.
PubMed 26020101
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine GSK1024850A, Given Either as a Booster Dose or as a 2-dose Catch-up Immunization in Healthy Malian Children
- ClinicalTrials.gov ID
- NCT00985465
- Acronym / sponsor ID
- 113166
- Conditions
- Infections, Streptococcal
- Keywords
- Booster vaccination, Pneumococcal vaccine, Catch-up vaccination, Pneumococcal disease, Safety, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2009 (actual)
- Primary completion
- 26 Jun 2010 (actual)
- Study completion
- 26 Jul 2010 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301.
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 = NCT00678301).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pn-Pn group | Experimental | Biological: Pneumococcal vaccine GSK1024850Asubjects from the Pn-Pn group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in the Malian centre of study NCT00678301, receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A |
| Zil-Pn group | Experimental | Biological: Pneumococcal vaccine GSK1024850Asubjects from the unprimed group of the NCT00678301 Malian study centre, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A |
Who may qualify
- Ages
- 15 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- A male or female, between and including 15-21 months of age at the time of visit 1.
- For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
- Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
- Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Administration of any pneumococcal vaccine since the end of study NCT00678301.
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 vaccine GSK1024850AIntramuscular injection, 1 or 2 doses | Biological | Pn-Pn group, Zil-Pn group |
Primary outcome
Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)
Time frame: Within 31 days (Day 0-Day 30) after booster vaccination
The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.
11 secondary outcomes
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within 4 days (Day 0-Day 3) after the booster dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within 4 days (Day 0-Day 3) after the booster dose
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within 4 days (Day 0-Day 3) after each vaccine dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within 4 days (Day 0-Day 3) after each vaccine dose
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 31 days (Day 0-Day 30) after each vaccine dose
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From the first vaccination up to one month (31 days) after the last vaccination for each subject
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Concentrations of Antibodies Against Protein D (PD)
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23291945Dicko A, Santara G, Mahamar A, Sidibe Y, Barry A, Dicko Y, Diallo A, Dolo A, Doumbo O, Shafi F, Francois N, Strezova A, Borys D, Schuerman L. Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Hum Vaccin Immunother. 2013 Feb;9(2):382-8. doi: 10.4161/hv.22692. Epub 2013 Jan 4.
- BackgroundDicko A et al. Safety and immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Abstract presented at the 7th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011 (Abstract 532).
- BackgroundDicko et al. Safety/reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) in Malian children. Abstract presented at the 8th International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March 2012 (Abstract 085).
- Derived from this study: PubMed 26020101Dicko A, Dicko Y, Barry A, Sidibe Y, Mahamar A, Santara G, Dolo A, Diallo A, Doumbo O, Shafi F, Francois N, Yarzabal JP, Strezova A, Borys D, Schuerman L. Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study. Hum Vaccin Immunother. 2015;11(9):2207-14. doi: 10.1080/21645515.2015.1016679.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pneumococcal vaccine GSK1024850A in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Mali.
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 12 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 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. 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 2018). 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?
Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited) (time frame: Within 31 days (Day 0-Day 30) after booster vaccination). 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 NCT00985465, which also lists 4 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 2018.