B7471015 - A PHASE 4 STUDY USING A TEST-NEGATIVE DESIGN TO EVALUATE THE EFFECTIVENESS OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE AGAINST VACCINE-TYPE RADIOLOGICALLY-CONFIRMED COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS ≥65 YEARS OF AGE

Conditions

VACCINE-TYPE RADIOLOGICALLY-CONFIRMED COMMUNITY-ACQUIRED PNEUMONIA

Brief summary

VE calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables.

Detailed description

VE calculated as 1 minus the OR for 20vPnC vaccination among cases versus controls* multiplied by 100 adjusted for potentially confounding variables., VE calculated as 1 minus the OR of 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables, using data from European/Israeli participants, Among participants with RAD+CAP: • VE by age group (i.e., 65–74 years, 75–84 years, and ≥85 years) • VE by sex (i.e., male vs female) • VE by ACIP-defined risk group and by age group, VE by prior influenza vaccination in past 12 months (ie, vaccinated vs. non-vaccinated); VE by co-administration of influenza vaccination, VE against 13vPnC serotypes, the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C and 20vPnC serotypes by previous vaccination with 13vPnC, VE against individual serotypes, VE against the 13 shared serotypes contained in 20vPnC and 13vPnC

Related papers

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Interventions

DRUGApexxnar suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent

DRUGadsorbed)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
VE calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables.	—

Secondary

Measure	Time frame
VE calculated as 1 minus the OR for 20vPnC vaccination among cases versus controls* multiplied by 100 adjusted for potentially confounding variables., VE calculated as 1 minus the OR of 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables, using data from European/Israeli participants, Among participants with RAD+CAP: • VE by age group (i.e., 65–74 years, 75–84 years, and ≥85 years) • VE by sex (i.e., male vs female) • VE by ACIP-defined risk group and by age group, VE by prior influenza vaccination in past 12 months (ie, vaccinated vs. non-vaccinated); VE by co-administration of influenza vaccination, VE against 13vPnC serotypes, the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C and 20vPnC serotypes by previous vaccination with 13vPnC, VE against individual serotypes, VE against the 13 shared serotypes contained in 20vPnC and 13vPnC	—

Measure

Time frame

VE calculated as 1 minus the OR for 20vPnC vaccination among cases versus controls* multiplied by 100 adjusted for potentially confounding variables., VE calculated as 1 minus the OR of 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables, using data from European/Israeli participants, Among participants with RAD+CAP: • VE by age group (i.e., 65–74 years, 75–84 years, and ≥85 years) • VE by sex (i.e., male vs female) • VE by ACIP-defined risk group and by age group, VE by prior influenza vaccination in past 12 months (ie, vaccinated vs. non-vaccinated); VE by co-administration of influenza vaccination, VE against 13vPnC serotypes, the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C and 20vPnC serotypes by previous vaccination with 13vPnC, VE against individual serotypes, VE against the 13 shared serotypes contained in 20vPnC and 13vPnC

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Countries

Spain

Outcome results

None listed