Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
11 juin 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
753
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
1 mois à 2 mois (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
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Expérimental: 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.
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Intramuscular injection
Intramuscular injection
Intramuscular injection
|
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Expérimental: 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.
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Intramuscular injection
Intramuscular injection
Intramuscular injection
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: At Month 13 (prior booster) and at Month 14 (one month after the booster dose)
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The cut-off value for the rSBA titers was ≥ 1:8
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At Month 13 (prior booster) and at Month 14 (one month after the booster dose)
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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
Délai: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
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The cut-off value for the rSBA titers was ≥ 1:128
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At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
|
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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
Délai: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
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Antibody titers are presented as geometric mean titers (GMTs).
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At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
|
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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
Délai: 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)
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The cut-off values for the rSBA antibody titers were ≥ 1:8 and ≥ 1:128
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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)
|
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rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups
Délai: 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)
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Antibody titers are presented as geometric mean titers (GMTs).
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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)
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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
Délai: 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.
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At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
|
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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)
Délai: 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.
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At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
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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
Délai: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
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Antibody titers are presented as geometric mean titers (GMTs).
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At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
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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)
Délai: 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)
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The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.
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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)
|
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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)
Délai: 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)
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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
Délai: 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.
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At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group)
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Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL).
Délai: 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.
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At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
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Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL)
Délai: 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.
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At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
|
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Anti-pneumococcal Antibody Concentrations
Délai: 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)
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At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
|
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Number of Subjects With Anti-diphtheria (Anti-D) Antibodies
Délai: 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)
|
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Concentration of Antibodies Against Diphtheria Antigens (Anti-D)
Délai: 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)
Délai: 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)
|
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Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.
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Within 31 days (Day 0-30) post each primary vaccine dose
|
|
Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase)
Délai: 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.
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Within 31 days (Day 0-30) post booster vaccination
|
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Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
Délai: From Day 0 to Month 19
|
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
|
From Day 0 to Month 19
|
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Number of Subjects With Serious Adverse Events (SAEs)
Délai: From Day 0 to Month 19
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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.
|
From Day 0 to Month 19
|
Collaborateurs et enquêteurs
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Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 janvier 2012
Achèvement primaire (Réel)
4 août 2014
Achèvement de l'étude (Réel)
19 octobre 2015
Dates d'inscription aux études
Première soumission
14 avril 2011
Première soumission répondant aux critères de contrôle qualité
21 avril 2011
Première publication (Estimation)
25 avril 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 114858
- 2013-002537-37 (Numéro EudraCT)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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