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Blood Sampling

Phase 4

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

Blood Sampling development status

Highest phase Phase 4 run by Merck KGaA, Darmstadt, Germany (NCT01419249)
Phase scored for PFEPhase 3
Registered trials 49 across 18 sponsors since Oct 2005

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

Blood Sampling clinical trials

Blood Sampling · 1 trial · 1 indication

Phase 3 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.

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.

Interventions

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

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:Finland
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Frequently asked questions about Blood Sampling

What is Blood Sampling used for?

Blood Sampling is an investigational clinical study program by Pfizer, Inc. (PFE) involving healthy volunteers and patients with meningococcal infections. The studies evaluate immunity and antibody persistence after meningococcal vaccination. It is currently in clinical development and is not approved by the FDA.

What does Blood Sampling target?

Blood Sampling does not target a specific molecular target. It is a clinical study program that evaluates immune responses, specifically antibody persistence, after meningococcal vaccination in healthy children and adults. The studies measure the duration of immunity following vaccination.

Who makes Blood Sampling?

Blood Sampling is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE. The program includes clinical studies sponsored by Pfizer to evaluate immunity after meningococcal vaccination.

What phase is Blood Sampling in?

Blood Sampling is in Phase 1 clinical development, based on the earliest-stage trial in the program. One completed trial is Phase 1, and another completed trial is Phase 3. All trials are completed, and the program is investigational, not FDA approved.

What clinical trials is Blood Sampling in?

Blood Sampling includes two completed trials: NCT00518492, a Phase 1 study evaluating the duration of immunity in healthy adults who completed a prior study, and NCT01900899, a Phase 3 study of antibody persistence after meningococcal vaccine PF-06866681 in healthy children. Both trials are completed.

Is Blood Sampling the same as PF-06866681?

Blood Sampling is not the same as PF-06866681. PF-06866681 is a meningococcal vaccine evaluated in one of the Blood Sampling trials, NCT01900899. Blood Sampling refers to the overall study program, not a specific drug or vaccine.