Meningococcal Infection Clinical Trial
Official title:
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
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.
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.
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