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

October 1, 2014 updated by: Pfizer

A Phase 4, Randomized, Placebo-Controlled Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine Efficacy in Prevention of Vaccine-Serotype Pneumococcal Community-Acquired Pneumonia and Invasive Pneumococcal Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84496

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Abbekerk, Netherlands, 1657 AH
        • Pfizer Investigational Site
      • Alkmaar, Netherlands, 1815 JD
        • Pfizer Investigational Site
      • Alkmaar, Netherlands, 1825 PV
        • Pfizer Investigational Site
      • Almelo, Netherlands, 7609 PP
        • Pfizer Investigational Site
      • Almere, Netherlands, 1315 RA
        • Pfizer Investigational Site
      • Almere, Netherlands, 1355 EA
        • Pfizer Investigational Site
      • Alphen aan de Rijn, Netherlands, 2402 EP
        • Pfizer Investigational Site
      • Amersfoort, Netherlands, 3813 TZ
        • Pfizer Investigational Site
      • Amersfoort, Netherlands, 3821 AR
        • Pfizer Investigational Site
      • Amstelveen, Netherlands, 1186 AM
        • Pfizer Investigational Site
      • Amstelveen, Netherlands, 1186 DA
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1081 HV
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1105 AZ
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1043 GR
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1061 AE
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1066 EC
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1091 AC
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1098 NJ
        • Pfizer Investigational Site
      • Apeldoorn, Netherlands, 7333 NS
        • Pfizer Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Pfizer Investigational Site
      • Apeldoorn, Netherlands, 7336 BA
        • Pfizer Investigational Site
      • Arnhem, Netherlands, 6815 AD
        • Pfizer Investigational Site
      • Arnhem, Netherlands, 6842 CT
        • Pfizer Investigational Site
      • Assen, Netherlands, 9401 RK
        • Pfizer Investigational Site
      • Assen, Netherlands, 9406 GT
        • Pfizer Investigational Site
      • Baarle-Nassau, Netherlands, 5111 BX
        • Pfizer Investigational Site
      • Baarn, Netherlands, 3743 CM
        • Pfizer Investigational Site
      • Bedum, Netherlands, 9781 JG
        • Pfizer Investigational Site
      • Bennebroek, Netherlands, 2121 AJ
        • Pfizer Investigational Site
      • Bergen op Zoom, Netherlands, 4611 RD
        • Pfizer Investigational Site
      • Bergen op Zoom, Netherlands, 4624 VT
        • Pfizer Investigational Site
      • Berkel Enschot, Netherlands, 5056 PP
        • Pfizer Investigational Site
      • Berkhout, Netherlands, 1647 ME
        • Pfizer Investigational Site
      • Bilthoven, Netherlands, 3723 BM
        • Pfizer Investigational Site
      • Blaricum, Netherlands, 1261 AN
        • Pfizer Investigational Site
      • Breda, Netherlands, 4818 CK
        • Pfizer Investigational Site
      • Breda, Netherlands, 4811 VC
        • Pfizer Investigational Site
      • Breda, Netherlands, 4835 ND
        • Pfizer Investigational Site
      • Brunssum, Netherlands, 6444 AT
        • Pfizer Investigational Site
      • Deventer, Netherlands, 7416 SE
        • Pfizer Investigational Site
      • Deventer, Netherlands, 7418 EV
        • Pfizer Investigational Site
      • Dongen, Netherlands, 5104 JK
        • Pfizer Investigational Site
      • Eelde, Netherlands, 9761 AB
        • Pfizer Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • Pfizer Investigational Site
      • Eindhoven, Netherlands, 5631 BM
        • Pfizer Investigational Site
      • Eindhoven, Netherlands, 5600 HK
        • Pfizer Investigational Site
      • Eindhoven, Netherlands, 5611 ZB
        • Pfizer Investigational Site
      • Eindhoven, Netherlands, 5616 BA
        • Pfizer Investigational Site
      • Emmen, Netherlands, 7811 HN
        • Pfizer Investigational Site
      • Emmen, Netherlands, 7824 AA
        • Pfizer Investigational Site
      • Enschede, Netherlands, 7513 ER
        • Pfizer Investigational Site
      • Enschede, Netherlands, 7521 AG
        • Pfizer Investigational Site
      • Epe, Netherlands, 8162 BD
        • Pfizer Investigational Site
      • Ettenleur, Netherlands, 4876 AS
        • Pfizer Investigational Site
      • Fijnaart, Netherlands, 4793 CB
        • Pfizer Investigational Site
      • Geldrop, Netherlands, 5664 EH
        • Pfizer Investigational Site
      • Geldrop, Netherlands, 5664 EP
        • Pfizer Investigational Site
      • Geldrop, Netherlands, 5664 HV
        • Pfizer Investigational Site
      • Goirle, Netherlands, 5051 RJ
        • Pfizer Investigational Site
      • Gouda, Netherlands, 2803 AH
        • Pfizer Investigational Site
      • Gouda, Netherlands, 2803 PL
        • Pfizer Investigational Site
      • Groningen, Netherlands, 9713 GZ
        • Pfizer Investigational Site
      • Groningen, Netherlands, 9713 EC
        • Pfizer Investigational Site
      • Groningen, Netherlands, 9728 NT
        • Pfizer Investigational Site
      • Groningen, Netherlands, 9733 CA
        • Pfizer Investigational Site
      • Grootebroek, Netherlands, 1613 SJ
        • Pfizer Investigational Site
      • Haarlem, Netherlands, 2035 RC
        • Pfizer Investigational Site
      • Haarlem, Netherlands, 2035 RJ
        • Pfizer Investigational Site
      • Haren, Netherlands, 9751 ND
        • Pfizer Investigational Site
      • Harmelen, Netherlands, 3481 EN
        • Pfizer Investigational Site
      • Heerhugowaard, Netherlands, 1701 GB
        • Pfizer Investigational Site
      • Heerlen, Netherlands, 6419 PC
        • Pfizer Investigational Site
      • Heerlen, Netherlands, 6412 CD
        • Pfizer Investigational Site
      • Heiloo, Netherlands
        • Pfizer Investigational Site
      • Helmond, Netherlands, 5707 HA
        • Pfizer Investigational Site
      • Hengelo, Netherlands, 7555 BB
        • Pfizer Investigational Site
      • Hengelo, Netherlands, 7555 DL
        • Pfizer Investigational Site
      • Hilvarenbeek, Netherlands, 5081JV
        • Pfizer Investigational Site
      • Hilversum, Netherlands, 1213 XZ
        • Pfizer Investigational Site
      • Hilversum, Netherlands, 1217 GP
        • Pfizer Investigational Site
      • Hoofddorp, Netherlands, 2134 TM
        • Pfizer Investigational Site
      • Hoogezand, Netherlands, 9601 KE�
        • Pfizer Investigational Site
      • Hoorn, Netherlands, 1624 NP
        • Pfizer Investigational Site
      • Hoorn, Netherlands, 1628 LZ
        • Pfizer Investigational Site
      • Hoorn, Netherlands, 1642 NP
        • Pfizer Investigational Site
      • Houten, Netherlands, 3995 AA
        • Pfizer Investigational Site
      • Kampen, Netherlands, 8266 AB
        • Pfizer Investigational Site
      • Katwijk, Netherlands, 2223 BM
        • Pfizer Investigational Site
      • Kerkrade, Netherlands, 6461 AL
        • Pfizer Investigational Site
      • Leek, Netherlands, 9351 KP
        • Pfizer Investigational Site
      • Leeuwarden, Netherlands, 8915 AC
        • Pfizer Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • Pfizer Investigational Site
      • Leiden, Netherlands, 2333 ZA
        • Pfizer Investigational Site
      • Leiden, Netherlands, 2316 XC
        • Pfizer Investigational Site
      • Leiden, Netherlands, 2334 CK
        • Pfizer Investigational Site
      • Leiderdorp, Netherlands, 2353 GA
        • Pfizer Investigational Site
      • Maarssen, Netherlands, 3603 BM
        • Pfizer Investigational Site
      • Maastricht, Netherlands, 6227 BZ
        • Pfizer Investigational Site
      • Maastricht, Netherlands, 6229 HX
        • Pfizer Investigational Site
      • Medemblik, Netherlands, 1671 CS
        • Pfizer Investigational Site
      • Nieuwegein, Netherlands, 3435 CM
        • Pfizer Investigational Site
      • Nieuwegein, Netherlands, 3439 ML
        • Pfizer Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • Pfizer Investigational Site
      • Nijmegen, Netherlands, 6532 SZ
        • Pfizer Investigational Site
      • Nijmegen, Netherlands, 6546 BC
        • Pfizer Investigational Site
      • Noordwijk, Netherlands, 2202 NS
        • Pfizer Investigational Site
      • Oldenzaal, Netherlands, 7573 AM
        • Pfizer Investigational Site
      • Oosterhout, Netherlands, 4907 AB
        • Pfizer Investigational Site
      • Peize, Netherlands, 9321 CK
        • Pfizer Investigational Site
      • Rheden, Netherlands, 6991 DV
        • Pfizer Investigational Site
      • Riel, Netherlands, 5133 AM
        • Pfizer Investigational Site
      • Rijsbergen, Netherlands, 4891 XL
        • Pfizer Investigational Site
      • Rijssen, Netherlands, 7461DA
        • Pfizer Investigational Site
      • Roden, Netherlands, 9301 JL
        • Pfizer Investigational Site
      • Roermond, Netherlands, 6042EH
        • Pfizer Investigational Site
      • Roermond, Netherlands, 6043 CV
        • Pfizer Investigational Site
      • Roermond, Netherlands, 6043 WD
        • Pfizer Investigational Site
      • Roosendaal, Netherlands, 4700 AZ
        • Pfizer Investigational Site
      • Roosendaal, Netherlands, 4708 HK
        • Pfizer Investigational Site
      • Schoorl, Netherlands, 1871 EE
        • Pfizer Investigational Site
      • Simpelveld, Netherlands, 6369 AG
        • Pfizer Investigational Site
      • Sittard, Netherlands, 6131 KJ
        • Pfizer Investigational Site
      • Sittard, Netherlands, 6162 BG
        • Pfizer Investigational Site
      • Sleen, Netherlands, 7841 CE
        • Pfizer Investigational Site
      • Soest, Netherlands, 3762 BN
        • Pfizer Investigational Site
      • Son, Netherlands, 5691 AR
        • Pfizer Investigational Site
      • Spaubeek, Netherlands, 6176 BE
        • Pfizer Investigational Site
      • Steenbergen, Netherlands, 4651 RN
        • Pfizer Investigational Site
      • Tiel, Netherlands, 4002 WP
        • Pfizer Investigational Site
      • Tilburg, Netherlands, 5022 GC
        • Pfizer Investigational Site
      • Tilburg, Netherlands, 5022 JB
        • Pfizer Investigational Site
      • Tilburg, Netherlands, 5042 AD
        • Pfizer Investigational Site
      • Uithoorn, Netherlands, 1422 LE
        • Pfizer Investigational Site
      • Urmond, Netherlands, 6129 EL
        • Pfizer Investigational Site
      • Utrecht, Netherlands, 3508 GA
        • Pfizer Investigational Site
      • Utrecht, Netherlands, 3524 SJ
        • Pfizer Investigational Site
      • Utrecht, Netherlands, 3525 AL
        • Pfizer Investigational Site
      • Utrecht, Netherlands, 3527 CE
        • Pfizer Investigational Site
      • Utrecht, Netherlands, 3565 CE
        • Pfizer Investigational Site
      • Utrecht, Netherlands, 3582 KE
        • Pfizer Investigational Site
      • Veldhoven, Netherlands, 5500 AA
        • Pfizer Investigational Site
      • Veldhoven, Netherlands, 5503 VV
        • Pfizer Investigational Site
      • Veldhoven, Netherlands, 5504 DB
        • Pfizer Investigational Site
      • Velp, Netherlands, 6883 AW
        • Pfizer Investigational Site
      • Venlo, Netherlands, 5912 BL
        • Pfizer Investigational Site
      • Venlo, Netherlands, 5911HH
        • Pfizer Investigational Site
      • Waalwijk, Netherlands, 5141 BM
        • Pfizer Investigational Site
      • Warmenhuizen, Netherlands, 1749 AK
        • Pfizer Investigational Site
      • Weert, Netherlands, 3001 BE
        • Pfizer Investigational Site
      • Woerden, Netherlands, 3447 GN
        • Pfizer Investigational Site
      • Zeist, Netherlands, 3703 CD
        • Pfizer Investigational Site
      • Zeist, Netherlands, 3707 HL
        • Pfizer Investigational Site
      • Zeist, Netherlands, 3707 HX
        • Pfizer Investigational Site
      • Zevenaar, Netherlands, 6903 ZN
        • Pfizer Investigational Site
      • Zutphen, Netherlands, 7201 NC
        • Pfizer Investigational Site
      • Zutphen, Netherlands, 7207 BA
        • Pfizer Investigational Site
      • Zwolle, Netherlands, 8025 AB
        • Pfizer Investigational Site
      • Zwolle, Netherlands, 8025 BT
        • Pfizer Investigational Site
    • Noord Brabant
      • Tilburg, Noord Brabant, Netherlands, 5022 JB
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: VACCINE: placebo
0.5 mL, single intra-muscular injection
Experimental: 13-valent pneumococcal conjugate vaccine
Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
0.5 mL, single intra-muscular injection
Other Names:
  • 13vPnC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)
Time Frame: 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).
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)
Time Frame: 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.
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)
Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases
Time Frame: 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).
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Time Frame: Within 7 days after vaccination
Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.
Within 7 days after vaccination
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Time Frame: Within 7 days after vaccination
Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.
Within 7 days after vaccination
Percentage of Participants Who Died
Time Frame: From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Deaths collected throughout the case acquisition period were presented.
From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Percentage of Participants With Newly Diagnosed Chronic Medical Condition
Time Frame: From 1 month after vaccination up to 6 months after vaccination
Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.
From 1 month after vaccination up to 6 months after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 1, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6115A1-3006
  • B1851025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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