rLP2086
Biological0.5 mL dose, given at 0, 2 and 6 months
NCT Number: NCT01352845
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.
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Notify Me18 year–25 year
All sexes
Interventional
Phase 3
Dr. Calvin Powell Professional Medical Corporation, Bay Roberts, Newfoundland and Labrador, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5 mL dose, given at 0, 2 and 6 months
0.5 mL dose, given at 0, 2 and 6 months
Time frame: One month after third bivalent rLP2086 vaccination
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.
Time frame: Within 7 days after first vaccination
Time frame: Within 7 days after second vaccination
Time frame: Within 7 days after third vaccination
Time frame: Within 7 days after first vaccination
Time frame: Within 7 days after second vaccination
Time frame: Within 7 days after third vaccination
Time frame: Within 30 days after first vaccination
Time frame: Within 30 days after second vaccination
Time frame: Within 30 days after third vaccination
Time frame: Within 30 days after any vaccination
Time frame: From the first vaccination up to 1 month after the third vaccination
Time frame: Within 30 days after first vaccination
Time frame: Within 30 days after second vaccination
Time frame: Within 30 days after third vaccination
Time frame: Within 30 days after any vaccination
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Time frame: From the first vaccination up to 1 month after the third vaccination
Time frame: From the first vaccination up to 6 month after the third vaccination
Time frame: Within 30 days after first vaccination
Time frame: Within 30 days after second vaccination
Time frame: Within 30 days after third vaccination
Time frame: Within 30 days after any vaccination
Time frame: From the first vaccination up to 1 month after the third vaccination
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Time frame: From the first vaccination up to 6 month after the third vaccination
Time frame: Within 30 days after first vaccination
Time frame: Within 30 days after second vaccination
Time frame: Within 30 days after third vaccination
Time frame: Within 30 days after any vaccination
Time frame: From the first vaccination up to 1 month after the third vaccination
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Time frame: From the first vaccination up to 6 month after the third vaccination the third vaccination
Time frame: Within 30 minutes after first vaccination
Time frame: Within 30 minutes after second vaccination
Time frame: Within 30 minutes after third vaccination
Time frame: From the first vaccination up to 1 month after the third vaccination
Time frame: Before first vaccination, 1 month after third vaccination
Time frame: Before first vaccination, 1 month after third vaccination (Vac)
Time frame: Before first vaccination, 1 month after third vaccination
Time frame: Before vaccination 1, 1 Month after Vaccination 2
Time frame: One month after second Bivalent rLP2086 vaccination
Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
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'.
Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Time frame: One month after third bivalent rLP2086 vaccination
Time frame: One month after third bivalent rLP2086 vaccination
Pfizer
Industry
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
Acronym: B1971016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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