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Vaccine, Vaccine, Vaccine, Vaccine, Vaccine

Phase 2

Meningococcal Vaccine | Unknown | Infectious Disease |Pfizer, Inc.|Last Updated: Oct 27, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment1,714

FDA Designations

No designations recorded

Clinical trial landscape

Vaccine, Vaccine, Vaccine, Vaccine, Vaccine · 1 trial · 1 indication

Phase 2 1
NCT01299480A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 YearsMeningococcal Vaccine
COMPLETED1,714 Analytics
PHASE2COMPLETED
A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years
Meningococcal Vaccine
NCT012994801,714
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Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants
1 month after Injection 4
Percentage of Participants Reporting At Least 1 Adverse Event (AE)
Injection 1 up to 1 month after Injection 4

Secondary Endpoints

Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants
1 month after Injection 4
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4
Percentage of Participants Achieving hSBA Titer >=LLOQ
Before Injection 1, 1 Month after Injection 2, 3, 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALrLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Group 2EXPERIMENTALrLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Group 3EXPERIMENTALrLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Group 4EXPERIMENTALrLP2086 at visits 1 and 3, saline at visits 2 and 5
Group 5EXPERIMENTALrLP2086 at visits 3 and 5, saline at visits 1 and 2

Interventions

NameTypeDescription
VaccineBIOLOGICALrLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
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Eligibility Criteria

Age Range11 Years to 18 Years
SexALL
Healthy VolunteersYes
Study Sites63

Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study. * Parent/legally acceptable representative and/or subjects who are willing a...

Countries:CzechiaDenmarkFinlandGermanyPolandSpainSweden
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Frequently asked questions about Vaccine, Vaccine, Vaccine, Vaccine, Vaccine

What is 1 mg, 5 mg, 10 mg used for?

1 mg, 5 mg, 10 mg is an investigational drug being studied for use in meningococcal vaccine, non-Hodgkin lymphoma, growth disorder, acute otitis media, hypogonadism, and healthy volunteers. It is currently in Phase 1 clinical development.

Who makes 1 mg, 5 mg, 10 mg?

1 mg, 5 mg, 10 mg is being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 1 clinical development.

What phase is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg has been studied in clinical trials including NCT00037791, NCT00039910, NCT00174421, and NCT01163851. These trials have investigated its use in conditions such as thrombocytopenia, non-Hodgkin lymphoma, growth disorder, and hypercholesterolemia.

Is 1 mg, 5 mg, 10 mg the same as PN-152,243?

1 mg, 5 mg, 10 mg is also known as PN-152,243 and PN-196,444 in clinical trials. These names refer to the same investigational drug being developed by Pfizer.