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pneumococcal 23v polysaccharide vaccine

Phase 3

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

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment143

FDA Designations

No designations recorded

Clinical trial landscape

pneumococcal 23v polysaccharide vaccine · 1 trial · 1 indication

Phase 3 1
NCT00560950Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)Pneumococcal Infection
COMPLETED143 Analytics
PHASE3COMPLETED
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
Pneumococcal InfectionUnlock trial analytics

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

ArmTypeDescription
1st Revaccination GroupEXPERIMENTAL -
2nd Revaccination GroupEXPERIMENTAL -

Interventions

NameTypeDescription
pneumococcal 23v polysaccharide vaccineBIOLOGICALDuration of Treatment: Single vaccination on Day 1
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Eligibility Criteria

Age Range59 Years to 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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Frequently asked questions about pneumococcal 23v polysaccharide vaccine

What is pneumococcal 23v polysaccharide vaccine used for?

Pneumococcal 23v polysaccharide vaccine is used for the prevention of pneumococcal infection, a disease caused by the bacterium Streptococcus pneumoniae. It is a vaccine that helps the immune system recognize and fight the bacteria, reducing the risk of serious infections such as pneumonia, bacteremia, and meningitis.

Who makes pneumococcal 23v polysaccharide vaccine?

Pneumococcal 23v polysaccharide vaccine is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is responsible for the research, development, and potential commercialization of this vaccine.

What phase is pneumococcal 23v polysaccharide vaccine in?

Pneumococcal 23v polysaccharide vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 3 trial is designed to evaluate the vaccine's safety and immunogenicity in older adults.

What clinical trials is pneumococcal 23v polysaccharide vaccine in?

Pneumococcal 23v polysaccharide vaccine has one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT00560950. This trial, titled "Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)," enrolled 143 participants aged 59 years and older to study revaccination with the vaccine.

Is pneumococcal 23v polysaccharide vaccine the same as PNEUMOVAX 23?

Yes, pneumococcal 23v polysaccharide vaccine is the same as PNEUMOVAX 23. The clinical trial NCT00560950 refers to the vaccine as PNEUMOVAX(TM) 23, which is the brand name for this pneumococcal polysaccharide vaccine developed by Merck.