Last reviewed · How we verify

NCT01732627

Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

Completed Phase 2 Results posted Last updated 4 April 2022
What this trial tests

Phase 2 trial testing Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine in Meningitis in 301 participants. Completed in 17 January 2013.

Timeline
12 November 2012
Primary endpoint
17 January 2013
17 January 2013

Quick facts

Lead sponsorSanofi Pasteur, a Sanofi Company
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment301
Start date12 November 2012
Primary completion17 January 2013
Estimated completion17 January 2013
Sites12 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

56 and older, any sex, with Meningitis or Meningococcal Meningitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Primary · Day 0 (pre-vaccination)

Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

Serogroup A: ≥1:4
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine95.992.1 – 98.2
Group 2: Menomune® A/C/Y/W 135 Vaccine96.891.0 – 99.3
Serogroup A: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine76.469.8 – 82.2
Group 2: Menomune® A/C/Y/W 135 Vaccine79.870.2 – 87.4
Serogroup C: ≥1:4
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine27.721.5 – 34.5
Group 2: Menomune® A/C/Y/W 135 Vaccine30.921.7 – 41.2
Serogroup C: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine17.412.4 – 23.5
Group 2: Menomune® A/C/Y/W 135 Vaccine10.65.2 – 18.7
Serogroup Y: ≥1:4
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine22.116.4 – 28.5
Group 2: Menomune® A/C/Y/W 135 Vaccine26.618.0 – 36.7
Serogroup Y: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine13.38.9 – 18.9
Group 2: Menomune® A/C/Y/W 135 Vaccine24.516.2 – 34.4
Serogroup W 135: ≥1:4
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine26.220.1 – 32.9
Group 2: Menomune® A/C/Y/W 135 Vaccine26.618.0 – 36.7
Serogroup W 135: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine13.38.9 – 18.9
Group 2: Menomune® A/C/Y/W 135 Vaccine8.53.7 – 16.1
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Primary · Day 30 (post-vaccination)

Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

Serogroup A: ≥1:4
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine97.494.1 – 99.2
Group 2: Menomune® A/C/Y/W 135 Vaccine93.686.6 – 97.6
Serogroup A: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine93.889.5 – 96.8
Group 2: Menomune® A/C/Y/W 135 Vaccine85.176.3 – 91.6
Serogroup C: ≥1:4
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine85.679.9 – 90.2
Group 2: Menomune® A/C/Y/W 135 Vaccine79.870.2 – 87.4
Serogroup C: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine74.968.2 – 80.8
Group 2: Menomune® A/C/Y/W 135 Vaccine62.852.2 – 72.5
Serogroup Y: ≥1:4
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine87.281.7 – 91.5
Group 2: Menomune® A/C/Y/W 135 Vaccine73.463.3 – 82.0
Serogroup Y: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine80.574.2 – 85.8
Group 2: Menomune® A/C/Y/W 135 Vaccine59.649.0 – 69.6
Serogroup W 135: ≥1:4
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine88.783.4 – 92.8
Group 2: Menomune® A/C/Y/W 135 Vaccine77.767.9 – 85.6
Serogroup W 135: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine79.573.1 – 84.9
Group 2: Menomune® A/C/Y/W 135 Vaccine60.650.0 – 70.6
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Primary · Day 30 (post-vaccination)

Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.

Serogroup A
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine65.158.0 – 71.8
Group 2: Menomune® A/C/Y/W 135 Vaccine46.836.4 – 57.4
Serogroup C
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine70.863.8 – 77.0
Group 2: Menomune® A/C/Y/W 135 Vaccine59.649.0 – 69.6
Serogroup Y
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine75.468.7 – 81.3
Group 2: Menomune® A/C/Y/W 135 Vaccine48.938.5 – 59.5
Serogroup W 135
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine74.467.6 – 80.3
Group 2: Menomune® A/C/Y/W 135 Vaccine55.344.7 – 65.6
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Primary · Day 0 (pre-vaccination)

GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

Serogroup A
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine9.738.65 – 10.9
Group 2: Menomune® A/C/Y/W 135 Vaccine10.48.58 – 12.5
Serogroup C
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine3.322.87 – 3.85
Group 2: Menomune® A/C/Y/W 135 Vaccine2.872.49 – 3.31
Serogroup Y
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine3.022.63 – 3.47
Group 2: Menomune® A/C/Y/W 135 Vaccine3.532.84 – 4.38
Serogroup W 135
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine2.832.56 – 3.14
Group 2: Menomune® A/C/Y/W 135 Vaccine2.832.40 – 3.33
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Primary · Day 30 (post-vaccination)

GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

Serogroup A
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine51.040.7 – 63.9
Group 2: Menomune® A/C/Y/W 135 Vaccine31.822.5 – 44.9
Serogroup C
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine48.334.8 – 67.1
Group 2: Menomune® A/C/Y/W 135 Vaccine18.512.1 – 28.3
Serogroup Y
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine41.931.8 – 55.3
Group 2: Menomune® A/C/Y/W 135 Vaccine16.611.3 – 24.5
Serogroup W 135
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine29.022.5 – 37.3
Group 2: Menomune® A/C/Y/W 135 Vaccine17.111.6 – 25.2
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Primary · Day 0 (pre-vaccination)

Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.

Serogroup A: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine28.222.0 – 35.1
Group 2: Menomune® A/C/Y/W 135 Vaccine26.918.2 – 37.1
Serogroup A: ≥1:128
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine22.116.4 – 28.5
Group 2: Menomune® A/C/Y/W 135 Vaccine22.614.6 – 32.4
Serogroup C: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine12.38.0 – 17.8
Group 2: Menomune® A/C/Y/W 135 Vaccine9.64.5 – 17.4
Serogroup C: ≥1:128
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine8.24.8 – 13.0
Group 2: Menomune® A/C/Y/W 135 Vaccine4.31.2 – 10.5
Serogroup Y: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine50.343.0 – 57.5
Group 2: Menomune® A/C/Y/W 135 Vaccine50.039.5 – 60.5
Serogroup Y: ≥1:128
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine27.721.5 – 34.5
Group 2: Menomune® A/C/Y/W 135 Vaccine20.212.6 – 29.8
Serogroup W 135: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine20.014.6 – 26.3
Group 2: Menomune® A/C/Y/W 135 Vaccine27.718.9 – 37.8
Serogroup W 135: ≥1:128
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine12.88.5 – 18.3
Group 2: Menomune® A/C/Y/W 135 Vaccine14.98.4 – 23.7
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Primary · Day 30 (post-vaccination)

Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.

Serogroup A: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine95.992.0 – 98.2
Group 2: Menomune® A/C/Y/W 135 Vaccine94.788.0 – 98.3
Serogroup A: ≥1:128
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine94.390.0 – 97.1
Group 2: Menomune® A/C/Y/W 135 Vaccine89.481.3 – 94.8
Serogroup C: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine95.992.0 – 98.2
Group 2: Menomune® A/C/Y/W 135 Vaccine87.278.8 – 93.2
Serogroup C: ≥1:128
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine93.388.8 – 96.4
Group 2: Menomune® A/C/Y/W 135 Vaccine77.767.9 – 85.6
Serogroup Y: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine97.494.1 – 99.2
Group 2: Menomune® A/C/Y/W 135 Vaccine94.788.0 – 98.3
Serogroup Y: ≥1:128
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine88.182.7 – 92.3
Group 2: Menomune® A/C/Y/W 135 Vaccine73.463.3 – 82.0
Serogroup W 135: ≥1:8
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine98.495.5 – 99.7
Group 2: Menomune® A/C/Y/W 135 Vaccine94.788.0 – 98.3
Serogroup W 135: ≥1:128
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine94.390.0 – 97.1
Group 2: Menomune® A/C/Y/W 135 Vaccine79.870.2 – 87.4
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Primary · Day 30 (post-vaccination)

Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers \<1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.

Serogroup A
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine90.285.1 – 94.0
Group 2: Menomune® A/C/Y/W 135 Vaccine89.281.1 – 94.7
Serogroup C
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine94.890.7 – 97.5
Group 2: Menomune® A/C/Y/W 135 Vaccine86.277.5 – 92.4
Serogroup Y
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine86.580.9 – 91.0
Group 2: Menomune® A/C/Y/W 135 Vaccine75.565.6 – 83.8
Serogroup W 135
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine95.391.3 – 97.8
Group 2: Menomune® A/C/Y/W 135 Vaccine90.482.6 – 95.5
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Primary · Day 0 (pre-vaccination)

GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.

Serogroup A
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine7.755.65 – 10.6
Group 2: Menomune® A/C/Y/W 135 Vaccine7.324.62 – 11.6
Serogroup C
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine3.402.76 – 4.18
Group 2: Menomune® A/C/Y/W 135 Vaccine2.932.28 – 3.77
Serogroup Y
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine15.311.4 – 20.7
Group 2: Menomune® A/C/Y/W 135 Vaccine13.18.63 – 19.9
Serogroup W 135
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine4.743.68 – 6.12
Group 2: Menomune® A/C/Y/W 135 Vaccine6.054.11 – 8.89
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Primary · Day 30 (post-vaccination)

GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.

Serogroup A
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine1054825 – 1346
Group 2: Menomune® A/C/Y/W 135 Vaccine746501 – 1109
Serogroup C
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine15591140 – 2131
Group 2: Menomune® A/C/Y/W 135 Vaccine445255 – 776
Serogroup Y
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine591464 – 753
Group 2: Menomune® A/C/Y/W 135 Vaccine260177 – 382
Serogroup W 135
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine910728 – 1136
Group 2: Menomune® A/C/Y/W 135 Vaccine493316 – 772
Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination Primary · Within 30 minutes after vaccination

An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were obse

GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine0
Group 2: Menomune® A/C/Y/W 135 Vaccine0
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination Primary · Within 7 days after vaccination

A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.

Pain
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine61
Group 2: Menomune® A/C/Y/W 135 Vaccine32
Erythema
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine23
Group 2: Menomune® A/C/Y/W 135 Vaccine5
Swelling
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine15
Group 2: Menomune® A/C/Y/W 135 Vaccine2
Fever
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine3
Group 2: Menomune® A/C/Y/W 135 Vaccine1
Headache
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine47
Group 2: Menomune® A/C/Y/W 135 Vaccine28
Malaise
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine44
Group 2: Menomune® A/C/Y/W 135 Vaccine15
Myalgia
GroupValue95% CI
Group 1: MenACYW Conjugate Vaccine70
Group 2: Menomune® A/C/Y/W 135 Vaccine26

Adverse events — posted to ClinicalTrials.gov

Time frame: Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: MenACYW Conjugate Vaccine
Serious: 0/199 (0%)
Deaths: 0/199
Group 2: Menomune® A/C/Y/W 135 Vaccine
Serious: 0/100 (0%)
Deaths: 0/100
Other adverse events (6 terms — click to expand)

ReactionSystemGroup 1: MenACYW Conjugate…Group 2: Menomune® A/C/Y/W…
MyalgiaMusculoskeletal and connective tissue disorders
Injection Site PainGeneral disorders
HeadacheNervous system disorders
MalaiseGeneral disorders
Injection Site ErythemaGeneral disorders
Injection Site SwellingGeneral disorders

Data from ClinicalTrials.gov NCT01732627 adverse events section.

Sponsor's own description

Primary objectives: * To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135. * To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study.
    Kirstein J, Pina M, Pan J, Jordanov E, et al · · 2020 · cited 19× · PMID 32233961 · DOI 10.1080/21645515.2020.1733868
  2. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered as a booster to adults aged ≥59 years: A phase III randomized study.
    Robertson CA, Jacqmein J, Selmani A, Galarza K, et al · · 2023 · cited 10× · PMID 36632042 · DOI 10.1080/21645515.2022.2160600
  3. Immune persistence and booster response of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) 5 years after primary vaccination of adults at ≥56 years of age.
    Robertson CA, Jacqmein J, Selmani A, Galarza K, et al · · 2024 · cited 3× · PMID 39555800 · DOI 10.1080/21645515.2024.2426868
  4. A new quadrivalent meningococcal tetanus toxoid conjugate vaccine: Menquadfi® (MENACWY-TT).
    Dinleyici EC, Ciftci E, Somer A, Yilmaz D, et al · · 2025 · cited 2× · PMID 40493501 · DOI 10.1080/21645515.2025.2516949
  5. [<i>Health Technology Assessment</i> (HTA) of the introduction of additional cohorts for anti-meningococcal vaccination with quadrivalent conjugate vaccines in Italy].
    Boccalini S, Panatto D, Mennini FS, Marcellusi A, et al · · 2021 · cited 2× · PMID 34622076 · DOI 10.15167/2421-4248/jpmh2021.62.1s1
  6. Immunogenicity and Safety of Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Potential Hajj/Umrah Pilgrims Aged ≥ 56 Years: A Phase III, Open-Label Study.
    Dbaibo GS, Balik I, Akdemir İ, Buzgan T, et al · · 2026 · PMID 41604139 · DOI 10.1007/s40121-025-01298-w
  7. Modeling antibody persistence after MenACYW-TT vaccination and comparative analysis with other quadrivalent meningococcal vaccines.
    Coudeville L, Bertrand-Gerentes I, Zocchetti C, Langevin E, et al · · 2025 · PMID 40640249 · DOI 10.1038/s41598-025-08112-0
  8. 1157. Immune Persistence and Booster Response of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) 5 Years After Primary Vaccination of Adults ≥59 Years of Age
    · 2023

Verify or expand the search:

Other recruiting trials for Meningitis

Currently open trials in the same condition.

Other Sanofi Pasteur, a Sanofi Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01732627.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing