- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985465
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bamako, Mali
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pn-Pn group
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
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Intramuscular injection, 1 or 2 doses
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Experimental: Zil-Pn group
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
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Intramuscular injection, 1 or 2 doses
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)
Time Frame: Within 31 days (Day 0-Day 30) after booster vaccination
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The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.
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Within 31 days (Day 0-Day 30) after booster vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time Frame: Within 4 days (Day 0-Day 3) after the booster dose
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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.
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Within 4 days (Day 0-Day 3) after the booster dose
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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
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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.
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Within 4 days (Day 0-Day 3) after the booster dose
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time Frame: Within 4 days (Day 0-Day 3) after each vaccine dose
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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.
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Within 4 days (Day 0-Day 3) after each vaccine dose
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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
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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.
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Within 4 days (Day 0-Day 3) after each vaccine dose
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Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time Frame: Within 31 days (Day 0-Day 30) after each vaccine dose
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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.
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Within 31 days (Day 0-Day 30) after each vaccine dose
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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
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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.
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From the first vaccination up to one month (31 days) after the last vaccination for each subject
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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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
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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).
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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
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Dicko 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Dataset Specification
Information identifier: 113166Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 113166Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 113166Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 113166Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 113166Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 113166Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 113166Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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