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Blood Sampling

Phase 3

Infections, Meningococcal | Unknown | Infectious Disease |Pfizer, Inc.|Last Updated: Jun 17, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment184

FDA Designations

No designations recorded

Clinical trial landscape

Blood Sampling · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT01900899Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy ChildrenInfections, Meningococcal
COMPLETED184 Analytics
PHASE3COMPLETED
Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
Infections, MeningococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
24 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
36 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
48 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
60 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
72 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Immunogenicity at 6 and 12 months post 6108A1-500 study.
6 and 12 months

Secondary Endpoints

Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
24, 36, 48, 60 and 72 months after booster Vaccination
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
Baseline up to the Month 72 after booster vaccination (up to 6 years)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
ACWY-TT groupEXPERIMENTALSubjects primed and boosted with the MenACWY-TT vaccine.
MenCCRM groupACTIVE_COMPARATORSubjects primed and boosted with the Meningitec vaccine.
Arm 1EXPERIMENTALIncludes subjects from a trial involving experimental vaccine and an active comparator vaccine. Comparator is Twinrix (not a MnB vaccine) and thus is comparator for safety but not immunogencity

Interventions

NameTypeDescription
Blood SamplingPROCEDUREAt 2, 3, 4, 5, 6 years after booster vaccination.
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Eligibility Criteria

Age Range18 Years to 25 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female who has received pri...

Countries:FinlandAustralia
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Frequently asked questions about Blood Sampling

What is Blood Sampling used for?

Blood Sampling is an investigational clinical study procedure used in trials evaluating immune responses in healthy volunteers and in the context of meningococcal infections. It is not a therapeutic drug but a sampling method employed to measure antibody persistence and duration of immunity following vaccination.

Who is developing Blood Sampling?

Blood Sampling is being developed by Pfizer, Inc. (NYSE: PFE). The company sponsors clinical trials that utilize blood sampling to assess immune responses, including studies of meningococcal vaccines in healthy children and adults.

What phase is Blood Sampling in?

Blood Sampling is associated with clinical trials in Phase 1 and Phase 3. One completed Phase 1 study evaluated duration of immunity in healthy adults, and a completed Phase 3 study assessed antibody persistence in healthy children after meningococcal vaccination.

What clinical trials is Blood Sampling in?

Blood Sampling is used in two completed trials: NCT00518492, a Phase 1 study in healthy adults in Australia evaluating duration of immunity, and NCT01900899, a Phase 3 study in healthy children in Finland assessing antibody persistence after meningococcal vaccine PF-06866681.

Is Blood Sampling the same as a vaccine?

No, Blood Sampling is not a vaccine. It is a clinical procedure for collecting blood samples to measure immune markers such as antibody levels. In the trials listed, it is used to evaluate responses to meningococcal vaccines, not as an intervention itself.