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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Meningococcal Infection

Treatments

Drug: bivalent rLP2086

Procedure: blood sampling

Study type

Interventional

Funder types

Industry

Identifiers

NCT01543087

B1971033

2011-005697-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

698 patients

Sex

All

Ages

10 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Stage 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.
Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
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.
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.

Inclusion Criteria for Booster Stage Visits 7-10 (up to12 month post booster follow up):

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.
Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study.
Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.
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.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
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.
Negative urine pregnancy test for all female subjects on the day of the booster dose.

Inclusion Criteria for Booster Stage Visit11 (26 month post booster follow up):

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.
Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
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.
Subject must have completed booster vaccination at Visit 7.

Exclusion Criteria for Stage 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.
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.
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.
History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate blood draw.
Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.
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).
Subjects who were not compliant with primary study eligibility criteria while enrolled in the primary study.

Exclusion Criteria for Booster Stage:

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.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
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.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Current chronic use of systemic antibiotics.
Current participation in another investigational study. Participation in purely observational studies is acceptable.
Received any investigational vaccines, drugs, or devices within 28 days before administration of the booster vaccination.
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
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.