pneumococcal 23v polysaccharide vaccine - Pneumococcal Infection | Phase 3 | Merck & Company, Inc. | BiopharmaWatch

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pneumococcal 23v polysaccharide vaccine

Phase 3

Pneumococcal Infection | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Apr 11, 2017

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

CONTROLLED

Total Trials1

Total Enrollment143

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT00560950	Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)	PHASE3	COMPLETED	143	—	—	Jul 1, 2007	May 1, 2008	Apr 11, 2017	-	—

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Study Endpoints

Primary Endpoints

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3

Day 1 & Day 30

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4

Day 1 & Day 30

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B

Day 1 & Day 30

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8

Day 1 & Day 30

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V

Day 1 & Day 30

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F

Day 1 & Day 30

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14

Day 1 & Day 30

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F

Day 1 & Day 30

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

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Study Design & Arms

AllocationNON_RANDOMIZED

MaskingNONE

ModelPARALLEL

PurposePREVENTION

Treatment Arms

Arm	Type	Description
1st Revaccination Group	EXPERIMENTAL	-
2nd Revaccination Group	EXPERIMENTAL	-

Interventions

Name	Type	Description
pneumococcal 23v polysaccharide vaccine	BIOLOGICAL	Duration of Treatment: Single vaccination on Day 1

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Eligibility Criteria

Age Range59 Years — N/A

SexALL

Healthy VolunteersYes

Inclusion Criteria: * Postmenopausal or negative urine pregnancy test if female * No fever on the day of vaccination Exclusion Criteria: * History of allergy to vaccine components * History of pneumococcal disease * Received any live virus vaccination within 4 weeks prior to study start * Receive...

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