A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

Meningococcal Vaccine Clinical Trial

Official title:

A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830855
• Other study ID #: B1971009
• Secondary ID: 6108A1-30012010-
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2013
• Last updated: June 4, 2015
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3597
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Male or female subject aged >=10 and <19 years at the time of enrollment.

2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

3. Negative urine pregnancy test for all female subjects.

Exclusion Criteria:

1. Previous vaccination with any meningococcal serogroup B vaccine.

2. Subjects who have received prior HAV vaccination.

3. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.

4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.

5. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.

6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).

7. Current chronic use of systemic antibiotics.

8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.

9. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Vaccine

Intervention

Biological:
• rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 1)
• rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 2)
• rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 3)
• Havrix (HAV)
0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
• Saline
0.5 mL dose of sterile normal saline for injection.

Locations

Country	Name	City	State
Canada	ALPHA Recherche Clinique	Quebec
Canada	Clinique Medicale St-Louis (recherche) Inc.	Quebec
Canada	DIEX Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Medicor Research Inc.	Sudbury	Ontario
Canada	Dr. Hartley Garfield Medicine Professional Corporation	Toronto	Ontario
Czech Republic	Ordinace praktickeho lekare pro deti a dorost	Brandys nad Labem - Stara Boleslav
Czech Republic	Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci,Centrum ockovani a cestovni mediciny	Hradec Kralove
Czech Republic	Ordinace praktickeho lekare pro deti a dorost	Hradec Kralove
Czech Republic	Ordinace praktickeho lekare pro deti a dorost	Jindrichuv Hradec
Czech Republic	Ordinace praktickeho lekare pro deti a dorost	Odolena Voda
Czech Republic	MUDr. Elena Adamkova	Pardubice
Czech Republic	Zdravotnicke stredisko Dubina v.o.s.	Pardubice
Czech Republic	Ordinace praktickeho lekare pro deti a dorost	Praha 6
Finland	Helsinki East Vaccine Research Clinic	Helsinki
Finland	Jarvenpaa Vaccine Research Clinic	Jarvenpaa
Finland	Oulu Vaccine Research Clinic	Oulu
Finland	Vantaa East Vaccine Research Clinic	Vantaa
Germany	Kinderarzt Praxis	Bramsche	Niedersachsen
Germany	Gemeinschaftspraxis für Kinder- und Jugendmedizin Dres. Behre, Burgert, Günkel	Kehl
Germany	Central Laboratory and Vaccination Centre, Stiftung Juliusspital	Wuerzburg	Bavaria
Italy	Department of Health Science - Section of Hygiene and Medicine Preventive	Genova
Italy	Fondazione IRCCS Cà Granda	Milan
Italy	Azienda Sanitaria Provinciale di Ragusa	Ragusa
Italy	Azienda Ospedaliero Universitaria di Sassari	Sassari
Italy	Servizio di Igiene e Sanita Pubblica	Sassari
Poland	Prywatny Gabinet Lekarski dr n med. Jerzy Brzostek	Debica
Poland	NZOZ Praktyka Lekarza Rodzinnego lek.med. Agata Slawin	Kielczow
Poland	Wojewodzka Poradnia Szczepien Ochronnych Krakowski Szpital Specjalistyczny im. Jana pawla II	Krakow	Malopolska
Poland	NZOZ Praktyka Lekarza Rodzinnego Eskulap	Lublin
Poland	NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska	Siemianowice Slaskie
Poland	NZOZ Praktyka Lekarza Rodzinnego Beata Stecka	Wroclaw
United Kingdom	University of Bristol, Clinical Research and Imaging Centre	Bristol
United Kingdom	St. George's, University of London	London
United Kingdom	Oxford Vaccine Group, University of Oxford	Oxford
United Kingdom	NIHR Wellcome Trust Clinical Research Facility	Southampton	Hampshire
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire
United States	Asheboro Research Associates	Asheboro	North Carolina
United States	Augusta Family Practice	Augusta	Kansas
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Bellevue Urgent Care	Bellevue	Nebraska
United States	Pioneer Clinical Research, LLC	Bellevue	Nebraska
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Birmingham Pediatric Associates, PC	Birmingham	Alabama
United States	Cary Pediatric Center	Cary	North Carolina
United States	Pediatric Research of Charlottesville	Charlottesville	Virginia
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics	Cleveland	Ohio
United States	Colorado Springs Health Partners/Clinical Research Advantage, Inc.	Colorado Springs	Colorado
United States	North Georgia Clinical Research Center dba Whites Pediatrics	Dalton	Georgia
United States	Dayton Clinical Research	Dayton	Ohio
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	Ohio Pediatrics, Inc.	Dayton	Ohio
United States	Northern Illinois Research Associates	DeKalb	Illinois
United States	Southeastern Pediatrics	Dothan	Alabama
United States	Liberty Family Practice	Erie	Pennsylvania
United States	David B. Ware, MD	Eunice	Louisiana
United States	Horizon Research Group of Opelousas, LLC	Eunice	Louisiana
United States	Harrisburg Family Medical Center	Harrisburg	Arkansas
United States	ACC Pediatric Research	Haughton	Louisiana
United States	Focus Research Group	Hendersonville	Tennessee
United States	AGA Clinical Trials	Hialeah	Florida
United States	Northpoint Pediatrics	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas
United States	Holston Medical Group	Kingsport	Tennessee
United States	Holston Medical Group Laboratory	Kingsport	Tennessee
United States	Cumberland Pediatrics Associates	Lebanon	Tennessee
United States	Arkansas Pediatric Clinic	Little Rock	Arkansas
United States	Bluegrass Clinical Research, Inc.	Louisville	Kentucky
United States	Accelovance	Melbourne	Florida
United States	Benchmark Research	Metairie	Louisiana
United States	Winthrop Division of Pediatric Infectious Diseases	Mineola	New York
United States	Winthrop Pediatric Associates	Mineola	New York
United States	Winthrop University Pharmacy	Mineola	New York
United States	Winthrop-University Hospital - Clinical Trials Center	Mineola	New York
United States	Accelovance, Inc.	Mishawaka	Indiana
United States	Optimal Research, LLC	Mishawaka	Indiana
United States	Mt. Sterling Pediatrics	Mountain Sterling	Kentucky
United States	Central Kentucky Research Associates,Inc.	MT. Sterling	Kentucky
United States	Nassim, McMonigle, Mescia & Associates	New Albany	Indiana
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Southwestern Medical Clinic - Lakeland HealthCare Affiliate	Niles	Michigan
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Meridian Clinical Research, Llc	Omaha	Nebraska
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	Manor Oak Two	Pittsburgh	Pennsylvania
United States	Capitol Pediatrics & Adolescent Center PLLC	Raleigh	North Carolina
United States	Capitol Pediatrics & Adolescent Center PLLC - Suite 100	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Allina Health Bandana Square Clinic	Saint Paul	Minnesota
United States	California Research Foundation	San Diego	California
United States	Southwestern Medical Clinic - Stevensville	Stevensville	Michigan
United States	Preferred Primary Care Physicians, Inc.	Uniontown	Pennsylvania
United States	PEAK Research, LLC	Upper St. Clair	Pennsylvania
United States	The Vancouver Clinic	Vancouver	Washington
United States	Advanced Pediatrics	Vienna	Virginia
United States	Heartland Research Associates	Wichita	Kansas
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Finland,  Germany,  Italy,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with titer = lower limit of quantitation (LLOQ) for all of the 4 primary test strains combined, at 1 month after the third vaccination with bivalent rLP2086 vaccine.		Month 7	No
Primary	Proportion of subjects achieving at least a 4-fold increase in titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the 4 primary test strains.		Baseline, month 7	No
Primary	Geometric mean titers 1 month after the third vaccination with bivalent rLP2086 for each of the 2 primary test strains.		Month 7	No
Primary	Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit.		Month 0	Yes
Primary	Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit.		Month 2	Yes
Primary	Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit.		Month 6	Yes
Primary	Percentage of subjects with at least 1 SAE 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period.		Up to 12 months	Yes
Primary	Percentage of subjects with at least 1 medically attended adverse event 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period.		Up to 12 months	Yes
Primary	Percentage of subjects with at least 1 newly diagnosed chronic medical condition 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period.		Up to 12 months	Yes
Primary	Percentage of subjects with at least 1 adverse event 30 days after each vaccination, 30 days after any vaccination and during the vaccination phase.		Up to 7 months	Yes
Primary	Percentage of subjects reporting at least 1 immediate AE after each vaccination.		Month 0	Yes
Primary	Percentage of subjects reporting at least 1 immediate AE after each vaccination.		Month 2	Yes
Primary	Percentage of subjects reporting at least 1 immediate AE after each vaccination.		Month 6	Yes
Primary	Subject's days missing school or work due to AEs during the vaccination phase.		Up to 7 months	Yes
Secondary	Proportion of subjects with a titer = lower limit of quantitation (LLOQ) for each of 10 test strains 1 month after the third vaccination.		Month 7	No
Secondary	Proportion of subjects with a titer = lower limit of quantitation (LLOQ) for each of 10 test strains 1 month after the second vaccination.		Month 3	No
Secondary	Proportion of subjects with a titer = lower limit of quantitation (LLOQ) for each of the 4 primary test strains at baseline with bivalent rLP2086 vaccine.		Month 0	No
Secondary	Proportion of subjects with a titer = lower limit of quantitation (LLOQ) for each of the 4 primary test strains 1 month after the second vaccination with bivalent rLP2086 vaccine.		Month 3	No
Secondary	Proportion of subjects achieving at least a 4-fold increase in titer from baseline to 1 month after the second vaccination with bivalent rLP2086 vaccine for each of the primary test strains sets.		Baseline, month 3	No
Secondary	Proportion of subjects achieving at least a 4-fold increase in titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the primary test strains sets.		Baseline, month 7	No
Secondary	Geometric mean titers at baseline with bivalent rLP2086 for each of the primary test strain sets.		Month 0	No
Secondary	Geometric mean titers 1 month after the second vaccination with bivalent rLP2086 for each of the primary test strain sets.		Month 3	No
Secondary	Proportions of subjects achieving hSBA titers of =LLOQ, =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 1 month after the second vaccination with bivalent rLP2086 vaccine for each of the		Month 3	No
Secondary	primary test strains sets.		Month 3	No
Secondary	Proportions of subjects achieving hSBA titers of =LLOQ, =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the		Month 7	No
Secondary	primary test strains sets.		Month 7	No
Secondary	Proportion of subjects achieving at least a 3-fold increase in titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the primary test strains sets.		Baseline, month 7	No
Secondary	Proportion of subjects achieving at least a 2-fold increase in titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the primary test strains sets.		Baseline, month 7	No

External Links

•   To obtain contact information for a study center near you, click here.