Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults (CAPITA)

Pfizer

Status and phase: Completed; Phase 4

Conditions: 13-valent Pneumococcal Vaccine; Pneumonia, Pneumococcal; Pneumococcal Infections

Treatments: Biological: VACCINE: 13-valent pneumococcal conjugate vaccine; Biological: VACCINE: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744263

B1851025

6115A1-3006

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.

Enrollment: 84,496 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements.

Exclusion criteria

• Previous vaccination with any licensed or experimental pneumococcal vaccine
• Residence in a nursing home, long-term care facility, or similar facility
• Known hypersensitivity to vaccination
• Immune deficiency or suppression

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84,496 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Biological: VACCINE: placebo

13-valent pneumococcal conjugate vaccine

Experimental group

Treatment:

Biological: VACCINE: 13-valent pneumococcal conjugate vaccine