Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 6108A1-2003 | Other Identifier | Alias Study Number | |
| 2009-014493-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3 |
|
| Group 2 | Experimental | rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2 |
|
| Group 3 | Experimental | rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3 |
|
| Group 4 | Experimental | rLP2086 at visits 1 and 3, saline at visits 2 and 5 |
|
| Group 5 | Experimental | rLP2086 at visits 3 and 5, saline at visits 1 and 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine | Biological | rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants | 1 month after Injection 4 | |
| Percentage of Participants Reporting At Least 1 Adverse Event (AE) | Injection 1 up to 1 month after Injection 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants | 1 month after Injection 4 | |
| Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) | Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer | 1 month after Injection 2, 3, 4 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordinace praktickeho lekare pro deti a dorost | Brandýs nad Labem-Stará Boleslav | 25001 | Czechia | |||
| Ordinace praktickeho lekare pro deti a dorost |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35164991 | Derived | Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11. | |
| 32681472 | Derived |
Not provided
Not provided
A total of 1714 participants were enrolled in this study. Of these, 1 participant was not randomized but was vaccinated with Saline at Injection 1. This participant was included in safety population and not intent-to-treat population. Participant Flow includes only randomized intent to treat participants.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month) | Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule. |
| FG001 | Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vaccine | Biological | rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2 |
|
|
| Vaccine | Biological | rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3 |
|
|
| Vaccine | Biological | rLP2086 at visits 1 and 3, saline at visits 2 and 5 |
|
|
| Vaccine | Biological | rLP2086 at visits 3 and 5, saline at visits 1 and 2 |
|
|
| Percentage of Participants Achieving hSBA Titer >=LLOQ | Before Injection 1, 1 Month after Injection 2, 3, 4 |
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Injection 1, 1 Month after Injection 2, 3, 4 |
| Chlumec nad Cidlinou |
| 50351 |
| Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Holice | 53401 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Hradec Králové | 50002 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Hradec Králové | 50004 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 50005 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Jindřichův Hradec | 37701 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Odolena Voda | 25070 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Pardubice | 53002 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Pardubice | 53012 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Prague | 11000 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Prague | 16000 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Praha - Horni Pocernice | 19300 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Praha - Nusle | 14000 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Praha 6 - Petriny | 16200 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Sezemice | 53304 | Czechia |
| Infektionsmedicinsk Afdeling Q | Aarhus N | 8200 | Denmark |
| Espoo Vaccine Research Clinic | Espoo | 02230 | Finland |
| Helsinki South Vaccine Research Clinic | Helsinki | 00100 | Finland |
| Helsinki East Vaccine Research Clinic | Helsinki | 00930 | Finland |
| Järvenpää Vaccine Research Clinic | Jarvenpaa | 04400 | Finland |
| Kokkola Vaccine Research Centre | Kokkola | 67100 | Finland |
| Lahti Vaccine Research Clinic | Lahti | 15140 | Finland |
| Oulu Vaccine Research Clinic | Oulu | 90220 | Finland |
| Porin Rokotetutkimusklinikka | Pori | 28100 | Finland |
| Seinäjoki Vaccine Research Clinic | Seinäjoki | 60100 | Finland |
| Tampere Vaccine Research Clinic | Tampere | 33100 | Finland |
| Turku Vaccine Research Clinic | Turku | 20520 | Finland |
| Vantaa East Vaccine Research Clinic | Vantaa | 01300 | Finland |
| Arztpraxis | Bad Saulgau | 88348 | Germany |
| Kinderarzt-Praxis | Bramsche | 49565 | Germany |
| Arztpraxis | Kleve | 47533 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | 55131 | Germany |
| Arztpraxis | Neumünster | 24534 | Germany |
| Kinderarztpraxis | Neumünster | 24534 | Germany |
| Kinderarztpraxis | Neustadt/Aisch | 91413 | Germany |
| Gabinet Lekarski | Dębica | 39-200 | Poland |
| Krakowski Szpital Specjalistyczny, im. Jana Pawla II | Krakow | 31-202 | Poland |
| NZOZ "Hipokrates-II" Sp. z o.o. | Krakow | 31-223 | Poland |
| Nzoz "Anamed" S.C | Lubartów | 21-100 | Poland |
| NZOZ Praktyka Lekarza Rodzinnego Eskulap | Lublin | 20-044 | Poland |
| NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak | Oborniki Śląskie | 55-120 | Poland |
| Specjalistyczny ZOZ nad Matka i Dzieckiem, | Poznan | 61709 | Poland |
| NZLA Michalkowice Jarosz i Partnerzy | Siemianowice Śląskie | 41-103 | Poland |
| NZOZ Nasz Lekarz | Torun | 87-100 | Poland |
| Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny | Trzebnica | 55-100 | Poland |
| NZOZ Salmed | Łęczna | 21-010 | Poland |
| Hospital General de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| Cap Vila Vella | SANT Vicenç DEL Horts | Barcelona | 08620 | Spain |
| Institut Pediatric Mares-Riera | Blanes | Girona | 17300 | Spain |
| Centro de Salud de Paiporta | Paiporta | Valencia | 46200 | Spain |
| Centro de Salud Quart de Poblet | Quart de Poblet | Valencia | 46930 | Spain |
| Hospital Virgen Del Mar | Almería | 04120 | Spain |
| Cap Roquetes-Canteres | Barcelona | 08042 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Centro de Salud Malvarrosa | Valencia | 46011 | Spain |
| Centro Superior de Investigacion en Salud Publica | Valencia | 46020 | Spain |
| Centro Superior de Salud Publica | Valencia | 46020 | Spain |
| Centro de Salud Republica Argentina | Valencia | 46021 | Spain |
| Centro de Salud Trafalgar | Valencia | 46023 | Spain |
| Malarsjukhuset, Infektionsmottagningen | Eskilstuna | 631 88 | Sweden |
| Skanes Universitetssjukhus Malmo, Barn- och Ungdomscentrum | Malmö | 205 02 | Sweden |
| CRS, Clinical Research Support | Örebro | 703 62 | Sweden |
| Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17. |
| 26407272 | Derived | Vesikari T, Ostergaard L, Diez-Domingo J, Wysocki J, Flodmark CE, Beeslaar J, Eiden J, Jiang Q, Jansen KU, Jones TR, Harris SL, O'Neill RE, York LJ, Crowther G, Perez JL. Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):152-60. doi: 10.1093/jpids/piv039. Epub 2015 Aug 4. |
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
| FG002 | Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month) | Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule. |
| FG003 | Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month) | Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule. |
| FG004 | Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) | Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month) | Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule. |
| BG001 | Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month) | Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule. |
| BG002 | Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month) | Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule. |
| BG003 | Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month) | Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule. |
| BG004 | Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) | Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants | The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain. | Posted | Number | percentage of participants | 1 month after Injection 4 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Reporting At Least 1 Adverse Event (AE) | Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received. | Posted | Number | percentage of participants | Injection 1 up to 1 month after Injection 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants | The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain. | Posted | Number | percentage of participants | 1 month after Injection 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) | The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain. | Posted | Geometric Mean | 95% Confidence Interval | titer | Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving hSBA Titer >=LLOQ | The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain. | Posted | Number | percentage of participants | Before Injection 1, 1 Month after Injection 2, 3, 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain. | Posted | Number | percentage of participants | Before Injection 1, 1 Month after Injection 2, 3, 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer | Results were not reported because a decision was made a priori that, although the fold rise outcome measure will still be performed, it will not be performed as a secondary outcome measure. Therefore it was moved from a secondary outcome measure in an earlier protocol version to an exploratory outcome measure in the final protocol. | Posted | 1 month after Injection 2, 3, 4 |
|
AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month) | Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule. | 12 | 426 | 113 | 426 | ||
| EG001 | Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month) | Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule. | 14 | 414 | 115 | 414 | ||
| EG002 | Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month) | Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule. | 7 | 451 | 114 | 451 | ||
| EG003 | Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month) | Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule. | 7 | 277 | 72 | 277 | ||
| EG004 | Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) | Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule. | 3 | 144 | 43 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tonsillitis streptococcal | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Near drowning | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Poisoning | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sympathetic posterior cervical syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| 14 - <19 years |
|
| Male |
|
| PMB2001 [A56] 1:8 (N=362, 359) |
|
|
| PMB2948 [B24] 1:8 (N=354, 354) |
|
|
| PMB2707 [B44] 1:8 (N356, 352) |
|
|
| Binomial Distribution |
| <0.001 |
| 2-Sided |
| Superiority or Other (legacy) |
| PMB2948 [B24]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant. | Binomial Distribution | <0.001 | 2-Sided | Superiority or Other (legacy) |
| PMB2707 [B44]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant. | Binomial Distribution | <0.001 | 2-Sided | Superiority or Other (legacy) |
| PMB80 [A22]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant. | Binomial Distribution | <0.001 | 2-Sided | Superiority or Other (legacy) |
| PMB2001 [A56]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant. | Binomial Distribution | <0.001 | 2-Sided | Superiority or Other (legacy) |
| PMB2948 [B24]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant. | Binomial Distribution | <0.001 | 2-Sided | Superiority or Other (legacy) |
| PMB2707 [B44]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant. | Binomial Distribution | <0.001 | 2-Sided | Superiority or Other (legacy) |
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
| OG004 | Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) | Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule. |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| PMB80 [A22] 1:8 (N=369) |
|
| ||||
| PMB2001 [A56] 1: 8 (N=370) |
|
| ||||
| PMB2948 [B24] 1:8 (N=359) |
|
| ||||
| PMB2707 [B44] 1:8 (N=356) |
|
|
|
| OG004 | Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) | Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule. |
|
|
| OG004 |
| Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) |
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule. |
|
|
| OG004 | Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) | Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule. |
|
|
| OG004 | Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) | Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|