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Pneumococcal Vaccine, Polyvalent

Phase 3

Pneumococcal Infection | Vaccine | Infectious Disease |Merck & Company, Inc.|Last Updated: Mar 14, 2017

Target and mechanism

ModalityVaccine

Also known as Pneumococcal Vaccine, Polyvalent (23-valent), Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23, Pneumococcal Vaccine, Polyvalent, PNEUMOVAX 23

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment133

FDA Designations

No designations recorded

Clinical trial landscape

Pneumococcal Vaccine, Polyvalent · 1 trial · 1 indication

Phase 3 1
NCT00496093Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)Pneumococcal Infection
COMPLETED133 Analytics
PHASE3COMPLETED
Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)
Pneumococcal InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b
post-vaccination

Secondary Endpoints

Any AE within 15 days after vaccination, with particular attention to injection site AE and fever
15 days after vaccination
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Pneumococcal Vaccine, Polyvalent (23-valent)EXPERIMENTALParticipants received one 0.5 mL dose of Pneumococcal Vaccine, Polyvalent (23-valent) by intramuscular (deltoid) injection on Day 1.

Interventions

NameTypeDescription
Pneumococcal Vaccine, Polyvalent (23-valent)BIOLOGICAL -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy indian adults of 50 years of age * In good health; any underlying chronic illness must be documented to be in stable condition * Signed and dated informed consent prior to receipt of the study vaccine Exclusion Criteria: * Functional or anatomic asplenia * History of...

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Frequently asked questions about Pneumococcal Vaccine, Polyvalent

What is Pneumococcal Vaccine, Polyvalent used for?

Pneumococcal Vaccine, Polyvalent is used to prevent pneumococcal infection. It is a vaccine developed by Merck & Company, Inc. (MRK) and is in Phase 3 clinical development. The vaccine is designed to protect against infections caused by Streptococcus pneumoniae bacteria.

Who makes Pneumococcal Vaccine, Polyvalent?

Pneumococcal Vaccine, Polyvalent is made by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the developer of this vaccine, which is also known as PNEUMOVAX 23.

What phase is Pneumococcal Vaccine, Polyvalent in?

Pneumococcal Vaccine, Polyvalent is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The only listed trial for this vaccine is a completed Phase 3 study.

What clinical trials is Pneumococcal Vaccine, Polyvalent in?

Pneumococcal Vaccine, Polyvalent has been studied in one completed Phase 3 clinical trial, NCT00496093, titled "Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)." This trial enrolled 133 healthy adults aged 50 years and older and is now completed.

Is Pneumococcal Vaccine, Polyvalent the same as PNEUMOVAX 23?

Yes, Pneumococcal Vaccine, Polyvalent is also known as PNEUMOVAX 23 or PNEUMOVAX™ 23. Other names include Pneumococcal Vaccine, Polyvalent (23-valent). These names refer to the same vaccine developed by Merck & Company, Inc. for the prevention of pneumococcal infection.