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| ID | Type | Description | Link |
|---|---|---|---|
| 6108A1-2008 | Other Identifier | Alias Study Number | |
| 2010-022449-38 | EudraCT Number |
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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 it is tolerated when given together with Repevax. The study will be done in healthy adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rLP2086 | Experimental | rLP2086 and Repevax |
|
| Saline and Repevax | Placebo Comparator | Saline and Repevax |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rLP2086 | Biological | 0.5 mL dose, given at 0, 2 and 6 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen | 1 month after Vaccination 1 | |
| Percentage of Participants With at Least One Adverse Event (AE) | Vaccination 1 up to 1 month after Vaccination 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens | 1 month after Vaccination 1 | |
| GMC for Acellular Pertussis Antigens | Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT) | Before vaccination 1, 1 month after Vaccination 2, 3 | |
| Geometric Mean Fold-Rise (GMFR) for IgG | Before Vaccination 1, 1 month after Vaccination 2, 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Espoo Vaccine Research Clinic | Espoo | 02100 | Finland | |||
| Helsinki South Vaccine Research Clinic |
| 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
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A total of 753 participants were enrolled in this study. Of these, 4 participants were not randomized but were vaccinated rLP2086 vaccine or Repevax or Saline at Vaccination 1. These participants were included in safety population and not intent-to-treat population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: rLP2086 + Repevax | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. |
| FG001 | Group 2: Saline+Repevax | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Repevax |
| Biological |
0.5 mL dose, given at 0 months. |
|
| Saline | Biological | 0.5 mL dose, given at 0, 2 and 6 months. |
|
| Repevax | Biological | 0.5 mL dose, given at 0 months. |
|
| 1 month after Vaccination 1 |
| Geometric Mean Titer (GMT) for Poliomyelitis Antigens | 1 month after Vaccination 1 |
| Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level | 1 month after Vaccination 3 |
| Helsinki |
| 00100 |
| Finland |
| Ita-Helsinki Vaccine Research Clinic | Helsinki | 00930 | Finland |
| Järvenpää Vaccine Research Clinic | Jarvenpaa | 04400 | Finland |
| Kokkola Vaccine Research Clinic | Kokkola | 67100 | Finland |
| Lahti Vaccine Research Clinic | Lahti | 15140 | Finland |
| Oulu Vaccine Research Clinic | Oulu | 90220 | Finland |
| Pori Vaccine Research Clinic | Pori | 28100 | Finland |
| Seinäjoki Vaccine Research Clinic | Seinäjoki | 60100 | Finland |
| Tampereen Yliopisto University Of Tampere | Tampere | 33014 | Finland |
| Tampere Vaccine Research Clinic | Tampere | 33100 | Finland |
| Vaccine Research Center | Tampere | FIN-33014 | Finland |
| Turku Vaccine Research Clinic | Turku | 20520 | Finland |
| Vantaa Vaccine Research Clinic | Vantaa | 01300 | Finland |
| Gemeinschaftspraxis Dr. med. Guido Hein, Dr. med. Rainer Lauf | Bad Sobernheim | 55566 | Germany |
| Gerhard Bleckmann Kinder- und Jugendarzt | Baunatal | 34225 | Germany |
| Kinderarzt-Praxis | Bramsche | 49565 | Germany |
| Gemeinschaftspraxis fuer Kinder- und Jugendmedizin Dres. Behre, Burgert, Gunkel | Kehl | 77694 | Germany |
| Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin | Lübeck | 23566 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | 55131 | Germany |
| Dr. Michael Vomstein, Hermann Oesterle, Kinder- und Jugendaerzte | Schwäbisch Hall | 74523 | Germany |
| Thomas Lenz & (Frau) Dr. med. Marin Eggers | Vellmar | 34246 | Germany |
| Dres.T. Schmitz, H. Knee, Ch, Wittermann Fachaerztliche | Weilheim | 82362 | Germany |
| Gemeinschaftspraxis fuer Kinder und Jugendliche Welzheim | Welzheim | 73642 | Germany |
| Gabinet Lekarski | Dębica | 39-200 | Poland |
| Krakowski Szpital Specjalistyczny, im. Jana Pawla II | Krakow | 31-202 | Poland |
| Specjalistyczna Praktyka Lekarska Gravita | Lodz | 91-347 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny | 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, Przychodnia Wieku Rozwojowego | Poznan | 61-825 | 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 |
| Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu | Wroclaw | 50-345 | Poland |
| NZOZ Salmed | Łęczna | 21-010 | Poland |
| 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. |
| 26803328 | Derived | Vesikari T, Wysocki J, Beeslaar J, Eiden J, Jiang Q, Jansen KU, Jones TR, Harris SL, O'Neill RE, York LJ, Perez JL. Immunogenicity, Safety, and Tolerability of Bivalent rLP2086 Meningococcal Group B Vaccine Administered Concomitantly With Diphtheria, Tetanus, and Acellular Pertussis and Inactivated Poliomyelitis Vaccines to Healthy Adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):180-7. doi: 10.1093/jpids/piv064. Epub 2016 Jan 23. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: rLP2086 + Repevax | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. |
| BG001 | Group 2: Saline+Repevax | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| BG002 | 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 Prespecified Criteria for the Concomitant Antigen | Posted | Number | percentage of participants | 1 month after Vaccination 1 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens | Posted | Geometric Mean | 95% Confidence Interval | International Units per milliliter | 1 month after Vaccination 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMC for Acellular Pertussis Antigens | Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 1 month after Vaccination 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer (GMT) for Poliomyelitis Antigens | Posted | Geometric Mean | 95% Confidence Interval | titer | 1 month after Vaccination 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level | Serum samples from approximately 50% of the participants had hSBA performed with primary MnB test strains expressing rLP2086 variants A22 and B24 and the other 50% of participants had hSBAs performed with strains expressing variants A56 and B44. 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 Vaccination 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT) | A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed. | Posted | Before vaccination 1, 1 month after Vaccination 2, 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Geometric Mean Fold-Rise (GMFR) for IgG | A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed. | Posted | Before Vaccination 1, 1 month after Vaccination 2, 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least One Adverse Event (AE) | Summary was performed for participants as per vaccine administration. | Posted | Number | percentage of participants | Vaccination 1 up to 1 month after Vaccination 3 |
|
|
AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax).
Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
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 + Repevax | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | 12 | 374 | 98 | 374 | ||
| EG001 | Group 2: Saline+Repevax | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. | 9 | 378 | 118 | 378 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Syndactyly | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | 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 |
|---|---|
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C484699 | factor H-binding protein, Neisseria meningitidis |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
|
| Male |
|
| Pertussis toxoid |
|
| Pertussis filamentous hemagglutinin |
|
| Pertussis pertactin |
|
| Pertussis fimbrial agglutinogens types 2+3 |
|
| Poliovirus type 1 |
|
| Poliovirus type 2 |
|
| Poliovirus type 3 |
|
Tetanus: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. |
| Percent difference |
| 0.0 |
| 2-Sided |
| 95 |
| -1.1 |
| 1.1 |
| Non-Inferiority or Equivalence (legacy) |
The non-inferiority criteria margin was 10%. |
| Pertussis toxoid: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | Percent difference | -1.3 | 2-Sided | 95 | -4.7 | 1.9 | Non-Inferiority or Equivalence (legacy) | The non-inferiority criteria margin was 10%. |
| Pertussis filamentous hemagglutinin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | Percent difference | 0.0 | 2-Sided | 95 | -1.1 | 1.1 | Non-Inferiority or Equivalence (legacy) | The non-inferiority criteria margin was 10%. |
| Pertussis pertactin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | Percent difference | 0.0 | 2-Sided | 95 | -1.1 | 1.1 | Non-Inferiority or Equivalence (legacy) | The non-inferiority criteria margin was 10%. |
| Pertussis fimbrial agglutinogens types 2+3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | Percent difference | -1.2 | 2-Sided | 95 | -3.6 | 0.8 | Non-Inferiority or Equivalence (legacy) | The non-inferiority criteria margin was 10%. |
| Poliovirus type 1: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | Percent difference | 0.0 | 2-Sided | 95 | -1.1 | 1.1 | Non-Inferiority or Equivalence (legacy) | The non-inferiority criteria margin was 10%. |
| Poliovirus type 2: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | Percent difference | 0.0 | 2-Sided | 95 | -1.1 | 1.1 | Non-Inferiority or Equivalence (legacy) | The non-inferiority criteria margin was 10%. |
| Poliovirus type 3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | Percent difference | 0.0 | 2-Sided | 95 | -1.1 | 1.1 | Non-Inferiority or Equivalence (legacy) | The non-inferiority criteria margin was 10%. |
|
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