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

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ClinicalTrials.gov Identifier: NCT00744263
Recruitment Status : Completed
First Posted : August 29, 2008
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumococcal Pneumococcal Infections 13-valent Pneumococcal Vaccine Biological: VACCINE: placebo Biological: VACCINE: 13-valent pneumococcal conjugate vaccine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 13vPnC


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744263


Locations
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Netherlands
Pfizer Investigational Site
Tilburg, Noord Brabant, Netherlands, 5022 JB
Pfizer Investigational Site
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, 1043 GR
Pfizer Investigational Site
Amsterdam, Netherlands, 1061 AE
Pfizer Investigational Site
Amsterdam, Netherlands, 1066 EC
Pfizer Investigational Site
Amsterdam, Netherlands, 1081 HV
Pfizer Investigational Site
Amsterdam, Netherlands, 1091 AC
Pfizer Investigational Site
Amsterdam, Netherlands, 1098 NJ
Pfizer Investigational Site
Amsterdam, Netherlands, 1105 AZ
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, 4811 VC
Pfizer Investigational Site
Breda, Netherlands, 4818 CK
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, 5600 HK
Pfizer Investigational Site
Eindhoven, Netherlands, 5611 ZB
Pfizer Investigational Site
Eindhoven, Netherlands, 5616 BA
Pfizer Investigational Site
Eindhoven, Netherlands, 5623 EJ
Pfizer Investigational Site
Eindhoven, Netherlands, 5631 BM
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 EC
Pfizer Investigational Site
Groningen, Netherlands, 9713 GZ
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, 6412 CD
Pfizer Investigational Site
Heerlen, Netherlands, 6419 PC
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, 2316 XC
Pfizer Investigational Site
Leiden, Netherlands, 2333 ZA
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, 5911HH
Pfizer Investigational Site
Venlo, Netherlands, 5912 BL
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
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00744263    
Other Study ID Numbers: 6115A1-3006
B1851025
First Posted: August 29, 2008    Key Record Dates
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Pneumococcal Infections
Pneumonia, Pneumococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs