Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

NCT ID: NCT01543087

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 698 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-07
• Study Completion Date: 2018-01-05

Brief Summary

This study is to assess the longevity of immune response in adolescents for approximately 48 months after receipt of a primary series of bivalent rLP2086 vaccination, which is then followed by a booster dose and an assessment of immune response for 12 or 26 months post booster vaccination.

Detailed Description

This study is to assess the longevity of immune responses in adolescents (aged 10 to <19 years at the time of entry into a primary study) following receipt of a vaccination regimen of 2 or 3 doses of bivalent rLP2086 in a primary study. A booster dose of bivalent rLP2086 at approximately 48 months was given following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series. The study was therefore divided into Stage 1 (4-year persistence of immune responses following receipt of a primary vaccination series) and the booster stage (follow-up through 12 months for all boosted or 26 months for a subset of the boosted).

Subjects participating only in Stage 1 will attend up to 6 study visits for collection of a 20-mL blood sample at each visit. Subjects participating in both Stage 1 and booster stage will attend up to 9-10 study visits with 1 visit for booster dose vaccination and 8-9 visits for collection of a 20-mL blood sample at each visit.

Conditions

Meningococcal Infection

Study Design

• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

One group of subjects

Group Type: OTHER

blood sampling

Intervention Type: PROCEDURE

Blood sample collection at different time points

bivalent rLP2086

Intervention Type: DRUG

A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.

Interventions

blood sampling

Blood sample collection at different time points

Intervention Type: PROCEDURE

bivalent rLP2086

A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.

2. Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.

3. Subjects who completed a primary study and received all the scheduled injections within the originally planned schedule, either with bivalent rLP2086 (either 2 or 3 doses) or with investigational product in cases where subject vaccine assignment is blinded at the time of consent for study B1971033.

4. Subjects who completed the blood draw following the last vaccination and subjects who completed the 6-month follow-up telephone call in the primary study.

1. Evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects for Visits 7 to 10 of the booster stage of the study.

1. For subject participating in Visit 11, evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects of Visit 11.

Exclusion Criteria

3. Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study.

4. Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.

5. Subject is available for the entire period of the booster stage and the subject or subject's parent(s)/legal guardian can be reached by telephone.

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

7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception through Visit 10 of the booster stage. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Refer to Section 4.5 for further information.

8. Negative urine pregnancy test for all female subjects on the day of the booster dose.

3. Subject must have received 2 or 3 doses of bivalent rLP2086 in the primary study on a 0-, 2-, and 6-month or a 0- and 6-month schedule.

4. Subject must have completed booster vaccination at Visit 7.

1. Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.

2. With the exception of the primary study of bivalent rLP2086, participation in other studies within the 1-month (30-day) period before study Visit 1 and/or during study participation. Participation in purely observational studies is permitted.

3. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

4. History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.

5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate blood draw.

6. Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.

7. Vaccination with any licensed or experimental meningococcal serogroup B vaccine since being enrolled in the primary Pfizer-sponsored MnB study (other than study vaccines permitted in the primary study).

8. Subjects who were not compliant with primary study eligibility criteria while enrolled in the primary study.

1. Subjects who are scheduled to receive 1 or more doses of a human papillomavirus (HPV) vaccine as part of a 3-dose series during the 28 days after the booster vaccination.

2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

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. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

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. Please refer to the study reference manual (SRM) for additional details.

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

7. Current chronic use of systemic antibiotics.

8. Current participation in another investigational study. Participation in purely observational studies is acceptable.

9. Received any investigational vaccines, drugs, or devices within 28 days before administration of the booster vaccination.

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

11. Pregnant female subjects, breastfeeding female subjects, male subjects with partners who are currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol through Visit 10 of the study.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

Chandler, Arizona, United States

Clinical Research Advantage, Inc./ East Valley Family Physicians, PLC

Chandler, Arizona, United States

St. Joseph Heritage Healthcare

Huntington Beach, California, United States

Center For Clinical Trials, LLC

Paramount, California, United States

California Research Foundation

San Diego, California, United States

Bayview Research Group

Valley Village, California, United States

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, United States

USF Health

Tampa, Florida, United States

North Georgia Research Clinical Center

Dalton, Georgia, United States

Pediatrics and Adolescent Medicine, PA

Marietta, Georgia, United States

Pediatrics And Adolescent Medicine, P.A.

Woodstock, Georgia, United States

Advanced Clinical Research

Meridian, Idaho, United States

Clinical Research Advantage, Inc.

Council Bluffs, Iowa, United States

Heartland Research Associates, LLC

Augusta, Kansas, United States

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

U of L Pediatrics: Downtown

Louisville, Kentucky, United States

Brownsboro Park Pediatrics

Louisville, Kentucky, United States

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, United States

Southwestern Medical Clinic Lakeland Healthcare Affiliate

Stevensville, Michigan, United States

The Center For Pharmaceutical Research

Kansas City, Missouri, United States

Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)

Fremont, Nebraska, United States

Midwest Children's Health Research Institute

Lincoln, Nebraska, United States

Creighton University Pediatric Infectious Diseases

Omaha, Nebraska, United States

Clinical Research Center of Nevada,LLC

Henderson, Nevada, United States

Dr. Shelly David Senders MD Inc. dba Senders Pediatrics

Cleveland, Ohio, United States

Ohio Pediatric Research Association

Dayton, Ohio, United States

Ohio Pediatrics, Inc

Dayton, Ohio, United States

West Houston Clinical Research Service (WHCRS)

Houston, Texas, United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States

BB Holdings, LLC., dba Jean Brown Research

Salt Lake City, Utah, United States

J. Lewis Research Inc, Jordan River Family Medicine

South Jordan, Utah, United States

Advanced Clinical Research

West Jordan, Utah, United States

The Vancouver Clinic, Inc. PS

Vancouver, Washington, United States

Monroe Clinic

Monroe, Wisconsin, United States

Research and Education Association for Clinical Health, Inc.

Monroe, Wisconsin, United States

Ordinace praktickeho lekare pro deti a dorost

Holice, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, , Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Odolena Voda, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Pardubice, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Pardubice, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Prague, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Praha - Nusle, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Sezemice, , Czechia

Aarhus University hospital Skejby

Aarhus N, , Denmark

Jarvenpaa Vaccine Research Clinic

Järvenpää, , Finland

Pori Vaccine Research Clinic

Pori, , Finland

Tampere Vaccine Research Clinic

Tampere, , Finland

Turku Vaccine Research Clinic

Turku, , Finland

Kinder - und Jugendarzt Praxis

Bad Saulgau, , Germany

Kinderarzt Praxis

Bramsche, , Germany

Infektionskliniken Malarsjukhuset

Eskilstuna, , Sweden

Skanes Universitetssjukhus

Malmo, , Sweden

Countries

United States; Czechia; Denmark; Finland; Germany; Sweden

References

Vesikari T, Ostergaard L, Beeslaar J, Absalon J, Eiden JJ, Jansen KU, Jones TR, Harris SL, Maansson R, Munson S, O'Neill RE, York LJ, Perez JL. Persistence and 4-year boosting of the bactericidal response elicited by two- and three-dose schedules of MenB-FHbp: A phase 3 extension study in adolescents. Vaccine. 2019 Mar 14;37(12):1710-1719. doi: 10.1016/j.vaccine.2018.11.073. Epub 2019 Feb 12.

Reference Type: DERIVED

PMID: 30770221 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1971033&StudyName=Duration%20of%20Immunity%20Study

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

Other Identifiers

2011-005697-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B1971033

Identifier Type: -

Identifier Source: org_study_id