A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

Healthy Clinical Trial

— B1971016  

Official title:

A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352845
• Other study ID #: B1971016
• Secondary ID: 6108A1-20042009-
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2011
• Last updated: January 26, 2016
• Start date: May 2013
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• 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 the immune response elicited by this vaccine when given to healthy young adults. 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: 3301
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Male or female subject aged >=18 and <26 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 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.

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

4. 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.

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

6. Current chronic use of systemic antibiotics.

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

8. 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

• Healthy

Intervention

Biological:
• rLP2086
0.5 mL dose, given at 0, 2 and 6 months

Other:
• Placebo
0.5 mL dose, given at 0, 2 and 6 months

Locations

Country	Name	City	State
Canada	Dr. Calvin Powell Professional Medical Corporation	Bay Roberts	Newfoundland and Labrador
Canada	Canadian Center for Vaccinology - IWK Health Centre	Halifax	Nova Scotia
Canada	Milestone Research	London	Ontario
Canada	McGill University Health Centre - Vaccine Study Centre	Pierrefonds	Quebec
Canada	Centre hospitalier universitaire de Québec	Quebec
Canada	Clinique Medicale St-Louis Inc.	Sainte-Foy, Québec	Quebec
Canada	London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario
Canada	Pro-Recherche Inc.	St-Romuald	Quebec
Canada	Devonshire Clinical Research Inc.	Woodstock	Ontario
Denmark	Aarhus Universitetshospital Skejby	Aarhus N
Finland	Espoo Vaccine Research Clinic	Espoo
Finland	Helsinki South Vaccine Research Clinic	Helsinki
Finland	Kokkola Vaccine Research Clinic	Kokkola
Finland	Seinäjoki Vaccine Research Clinic	Seinäjoki
Poland	NZOZ Centrum Medyczne Graniczna Sp. z o.o.	Katowice
Poland	Specjalistyczna Poradnia Medyczna Przyladek Zdrowia	Krakow
Poland	NZOZ Salmed s.c.	Leczna
Spain	CAP Balenya	Balenya	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	CAP Centelles	Centelles	Barcelona
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	FOM (Fundacion Oftalmologica del Mediterraneo) - FISABIO	Valencia
Spain	CAP El Remei	Vic	Barcelona
United States	Anaheim Clinical Trials LLC	Anaheim	California
United States	Bellevue Urgent Care	Bellevue	Nebraska
United States	Meridian Clinical Research	Bellevue	Nebraska
United States	Pioneer Clinical Research, LLC	Bellevue	Nebraska
United States	Community Research	Cincinnati	Ohio
United States	Rapid Medical Research	Cleveland	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	Research Across America	Dallas	Texas
United States	Coastal Medical	East Greenwich	Rhode Island
United States	Broward Research Group	Hollyood	Florida
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Research Across America	Katy	Texas
United States	eStudySite	La Mesa	California
United States	Altus Research Inc.	Lake Worth	Florida
United States	Johnson County Clin-Trials, Inc.	Lenexa	Kansas
United States	Central New York Clinical Research	Manlius	New York
United States	Clinical Research Advantage, Inc./Desert Clinical Research, LLC	Mesa	Arizona
United States	Benchmark Research	Metairie	Louisiana
United States	Milford Emergency Associates, Inc.	Milford	Massachusetts
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Meridian Clinical Research,	Omaha	Nebraska
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Benchmark Research	Sacramento	California
United States	Miami Research Associates	South Miami	Florida
United States	Premier Clinical Research	Spokane	Washington
United States	Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC	Tempe	Arizona
United States	Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC	Tempe	Arizona
United States	PEAK Research, LLC	Upper St. Clair	Pennsylvania
United States	Omega Medical Research	Warwick	Rhode Island
United States	Advanced Clinical Research	West Jordan	Utah
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Finland,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1	Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.	One month after third bivalent rLP2086 vaccination	No
Primary	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination		Within 7 days after first vaccination	Yes
Primary	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination		Within 7 days after second vaccination	Yes
Primary	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination		Within 7 days after third vaccination	Yes
Primary	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination		Within 7 days after first vaccination	Yes
Primary	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination		Within 7 days after second vaccination	Yes
Primary	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination		Within 7 days after third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination		Within 30 days after first vaccination	Yes
Primary	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination		Within 30 days after second vaccination	Yes
Primary	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination		Within 30 days after third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination		Within 30 days after any vaccination	Yes
Primary	Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination		Within 30 days after first vaccination	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination		Within 30 days after second vaccination	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination		Within 30 days after third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination		Within 30 days after any vaccination	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase		From 1 month after third vaccination up to 6 months after the third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period		From the first vaccination up to 6 month after the third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination		Within 30 days after first vaccination	Yes
Primary	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination		Within 30 days after second vaccination	Yes
Primary	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination		Within 30 days after third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination		Within 30 days after any vaccination	Yes
Primary	Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase		From 1 month after third vaccination up to 6 months after the third vaccination	Yes
Primary	Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period		From the first vaccination up to 6 month after the third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination		Within 30 days after first vaccination	Yes
Primary	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination		Within 30 days after second vaccination	Yes
Primary	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination		Within 30 days after third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination		Within 30 days after any vaccination	Yes
Primary	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase		From 1 month after third vaccination up to 6 months after the third vaccination	Yes
Primary	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period		From the first vaccination up to 6 month after the third vaccination the third vaccination	Yes
Primary	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination		Within 30 minutes after first vaccination	Yes
Primary	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination		Within 30 minutes after second vaccination	Yes
Primary	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination		Within 30 minutes after third vaccination	Yes
Primary	Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination	Yes
Secondary	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1		Before first vaccination, 1 month after third vaccination	No
Secondary	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1		Before first vaccination, 1 month after third vaccination (Vac)	No
Secondary	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1		Before first vaccination, 1 month after third vaccination	No
Secondary	Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1		Before vaccination 1, 1 Month after Vaccination 2	No
Secondary	Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1		One month after second Bivalent rLP2086 vaccination	No
Secondary	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1		Before Vaccination (Vac) 1, 1 Month after Vac 2, 3	No
Secondary	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary endpoint 'Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1'.	Before Vaccination (Vac) 1, 1 Month after Vac 2, 3	No
Secondary	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1		Before Vaccination (Vac) 1, 1 Month after Vac 2, 3	No
Secondary	Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination		One month after third bivalent rLP2086 vaccination	No
Secondary	Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1		One month after third bivalent rLP2086 vaccination	No

External Links

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