Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose
NCT01543087
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
for Stage 1:
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.
for Booster Stage:
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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose | ||||||
Official Title ICMJE | A PHASE 3 STUDY TO ASSESS THE PERSISTENCE OF HSBA RESPONSE UP TO 48 MONTHS AFTER COMPLETION OF A PRIMARY SERIES OF BIVALENT RLP2086, AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086 | ||||||
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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Other | ||||||
Condition ICMJE | Meningococcal Infection | ||||||
Intervention ICMJE |
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Study Arms ICMJE | One group of subjects
Interventions:
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Publications * | Vesikari T, Østergaard 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 698 | ||||||
Original Estimated Enrollment ICMJE | 800 | ||||||
Actual Study Completion Date ICMJE | January 5, 2018 | ||||||
Actual Primary Completion Date | January 5, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria for Stage 1:
Inclusion Criteria for Booster Stage Visits 7-10 (up to12 month post booster follow up):
Inclusion Criteria for Booster Stage Visit11 (26 month post booster follow up):
Exclusion Criteria for Stage 1:
Exclusion Criteria for Booster Stage:
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Sex/Gender ICMJE |
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Ages ICMJE | 10 Years to 18 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Czechia, Denmark, Finland, Germany, Sweden, United States | ||||||
Removed Location Countries | Czech Republic, Poland | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01543087 | ||||||
Other Study ID Numbers ICMJE | B1971033 2011-005697-31 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | February 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |