- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT01340898
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
2019. június 11. frissítette: GlaxoSmithKline
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK 134612) When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Részletes leírás
This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
753
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
1 hónap (Gyermek)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Extended administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine and seasonal or pandemic influenza vaccine.
- 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.
- Previous vaccination against diphtheria , tetanus, pertussis, polio (with the exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus pneumonia.
- History of receipt of meningococcal vaccine.
- Subjects who received a birth dose Hepatitis B vaccines within the 30 days before the administration of the first study vaccine.
- History of or intercurrent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of th
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: Nimenrix 3+1 Group
Subjects, male and female, received 4 doses of Nimenrix™ vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age).
All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
|
Intramuscular injection
Intramuscular injection
Intramuscular injection
|
Kísérleti: Nimenrix 1+1 Group
Subjects, male and female, received 2 doses of Nimenrix™ vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age).
All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
|
Intramuscular injection
Intramuscular injection
Intramuscular injection
|
Kísérleti: Nimenrix Control Group
Subjects, male and female, received 1 dose of Nimenrix™ at 15-18 months of age and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age).
All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
|
Intramuscular injection
Intramuscular injection
Intramuscular injection
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group
Időkeret: At Month 5 (one month post-dose 3)
|
The cut-off value for the rSBA titers was ≥ 1:8.
Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.
|
At Month 5 (one month post-dose 3)
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group
Időkeret: At Month 13 (prior booster) and at Month 14 (one month after the booster dose)
|
The cut-off value for the rSBA titers was ≥ 1:8
|
At Month 13 (prior booster) and at Month 14 (one month after the booster dose)
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group
Időkeret: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
|
The cut-off value for the rSBA titers was ≥ 1:128
|
At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group
Időkeret: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
|
Antibody titers are presented as geometric mean titers (GMTs).
|
At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups
Időkeret: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
|
The cut-off values for the rSBA antibody titers were ≥ 1:8 and ≥ 1:128
|
At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups
Időkeret: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
|
Antibody titers are presented as geometric mean titers (GMTs).
|
At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
|
Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group
Időkeret: At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
|
Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers < 1:8 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers >= 1:8 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination antibody titer.
|
At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups)
Időkeret: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
|
The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.
|
At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups
Időkeret: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
|
Antibody titers are presented as geometric mean titers (GMTs).
|
At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
|
Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control)
Időkeret: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)
|
The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.
|
At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control)
Időkeret: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)
|
Antibody titers are presented as geometric mean titers (GMTs).
|
At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)
|
Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group
Időkeret: At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group)
|
Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers < 1:4 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers >= 1:4 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination.
|
At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group)
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL).
Időkeret: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
|
The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
|
At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL)
Időkeret: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
|
The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
|
At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
|
Anti-pneumococcal Antibody Concentrations
Időkeret: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
|
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL)
|
At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
|
Number of Subjects With Anti-diphtheria (Anti-D) Antibodies
Időkeret: At Month 5 (one month post-dose 3)
|
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
|
At Month 5 (one month post-dose 3)
|
Concentration of Antibodies Against Diphtheria Antigens (Anti-D)
Időkeret: At Month 5 (one month post-dose 3)
|
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
|
At Month 5 (one month post-dose 3)
|
Concentration of Antibodies Against Diphtheria Antigens (Anti-D)
Időkeret: At Month 5 (one month post-dose 3)
|
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
The analysis was performed in a randomized subset of 25% of subjects of all three groups.
Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
|
At Month 5 (one month post-dose 3)
|
Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens
Időkeret: At Month 5 (one month post-dose 3)
|
Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
|
At Month 5 (one month post-dose 3)
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies
Időkeret: At Month 5 (one month post-dose 3)
|
Cut-off values assessed were greater than or equal to ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
|
At Month 5 (one month post-dose 3)
|
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies
Időkeret: At Month 5 (one month post-dose 3)
|
Antibody titers are presented as geometric mean titers (GMTs).
|
At Month 5 (one month post-dose 3)
|
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies
Időkeret: At Month 5 (one month post-dose 3)
|
Antibody titers are presented as geometric mean titers (GMTs).
The analysis was performed in a randomized subset of 25% of subjects of all three groups.
Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
|
At Month 5 (one month post-dose 3)
|
Number of Subjects With Anti-tetanus (Anti-T) Antibodies
Időkeret: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
|
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
|
At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
|
Concentration of Antibodies Against Tetanus Antigens (Anti-T)
Időkeret: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
|
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
|
At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
|
Number of Subjects With Anti-tetanus (Anti-T) Antibodies
Időkeret: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
|
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
The analysis was performed in a randomized subset of 25% of subjects of all three groups.
Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
|
At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
|
Anti-PRP Antibody Concentrations (Geometric Mean Concentrations) in a Randomized Subset of 25% of the Subjects
Időkeret: At Month 5 (one month post-dose 3)
|
The endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate [anti-PRP] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay.
|
At Month 5 (one month post-dose 3)
|
Number of Subjects With Solicited Local Symptoms (Primary Phase)
Időkeret: Within 8 days (Day 0-7) post primary vaccination
|
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.
|
Within 8 days (Day 0-7) post primary vaccination
|
Number of Subjects With Solicited Local Symptoms (Booster Phase)
Időkeret: Within 8 days (Day 0-7) post booster vaccination
|
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.
|
Within 8 days (Day 0-7) post booster vaccination
|
Number of Subjects With Solicited General Symptoms (Primary Phase)
Időkeret: Within 8 days (Day 0-7) post primary vaccination
|
Assessed solicited general symptoms were temperature [defined as rectally temperature equal to or above 38 degrees Celsius (°C)], drowsiness, irritability and loss of appetite.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 temperature = temperature > 40.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
|
Within 8 days (Day 0-7) post primary vaccination
|
Number of Subjects With Solicited General Symptoms (Booster Phase)
Időkeret: Within 8 days (Day 0-7) post booster vaccination
|
Assessed solicited general symptoms were temperature [defined as rectally temperature equal to or above 38 degrees Celsius (°C)], drowsiness, irritability and loss of appetite.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 temperature = temperature > 40.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
|
Within 8 days (Day 0-7) post booster vaccination
|
Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase)
Időkeret: Within 31 days (Day 0-30) post each primary vaccine dose
|
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.
|
Within 31 days (Day 0-30) post each primary vaccine dose
|
Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase)
Időkeret: Within 31 days (Day 0-30) post booster vaccination
|
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.
|
Within 31 days (Day 0-30) post booster vaccination
|
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
Időkeret: From Day 0 to Month 19
|
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
|
From Day 0 to Month 19
|
Number of Subjects With Serious Adverse Events (SAEs)
Időkeret: From Day 0 to Month 19
|
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.
|
From Day 0 to Month 19
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2012. január 27.
Elsődleges befejezés (Tényleges)
2014. augusztus 4.
A tanulmány befejezése (Tényleges)
2015. október 19.
Tanulmányi regisztráció dátumai
Először benyújtva
2011. április 14.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2011. április 21.
Első közzététel (Becslés)
2011. április 25.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2019. augusztus 6.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2019. június 11.
Utolsó ellenőrzés
2019. június 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 114858
- 2013-002537-37 (EudraCT szám)
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Meningococcal vaccine GSK 134612
-
GlaxoSmithKlineBefejezveFertőzések, MeningococcusEgyesült Államok, Kanada
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GlaxoSmithKlineBefejezveFertőzések, MeningococcusThaiföld, Panama, Fülöp-szigetek
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