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Pneumococcal Vaccine, Polyvalent

Phase 3

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

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 for the prevention of pneumococcal infection. It is an investigational vaccine being studied in healthy adults aged 50 years and older to assess its safety, tolerability, and immunogenicity. The vaccine is currently in Phase 3 clinical development.

Who makes Pneumococcal Vaccine, Polyvalent?

Pneumococcal Vaccine, Polyvalent is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The vaccine is being investigated for the prevention of pneumococcal infection.

What phase is Pneumococcal Vaccine, Polyvalent in?

Pneumococcal Vaccine, Polyvalent is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in preventing pneumococcal infection.

What clinical trials is Pneumococcal Vaccine, Polyvalent in?

Pneumococcal Vaccine, Polyvalent has one completed Phase 3 clinical trial, identified as NCT00496093. This trial, titled 'Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)', enrolled 133 participants aged 50 years and older to evaluate the vaccine's safety and immune response.

Is Pneumococcal Vaccine, Polyvalent the same as Pneumovax 23?

Yes, Pneumococcal Vaccine, Polyvalent is the same as Pneumovax 23. The clinical trial NCT00496093 refers to the vaccine as Pneumovax 23, indicating that these names are used interchangeably for the same investigational vaccine developed by Merck & Company, Inc.