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

Phase 4

Completed

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

• Registration Number: NCT00744263
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Study Start: 2008-09
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Results First Submitted: 2014-10-01
• Results First Submitted QC: 2014-10-01
• Last Update Submitted: 2014-10-01
• Results First Posted: 2014-10-06
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84496

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)	Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)	CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (\>) 38.0 degrees Celsius (C) or less than (\<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (\>10\*10\^9 white blood cells/liter or \>15 percent (%) bands), C-reactive protein level \>3 times upper limit of normal, hypoxemia with partial oxygen pressure \<60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)	Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)	CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature \>38.0 degrees C or \<36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (\>10\*10\^9 white blood cells/liter or \>15% bands), C-reactive protein level \>3 times upper limit of normal, hypoxemia with partial oxygen pressure \<60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.
Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases	Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)	VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇳🇱 Zwolle, Netherlands