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

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


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

MedlinePlus related topics: Pneumococcal Infections Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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.
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:

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.
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.
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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:	65 Years and older (Adult, Senior)
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

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

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Locations


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


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

Suaya JA, Jiang Q, Scott DA, Gruber WC, Webber C, Schmoele-Thoma B, Hall-Murray CK, Jodar L, Isturiz RE. Post hoc analysis of the efficacy of the 13-valent pneumococcal conjugate vaccine against vaccine-type community-acquired pneumonia in at-risk older adults. Vaccine. 2018 Mar 7;36(11):1477-1483. doi: 10.1016/j.vaccine.2018.01.049. Epub 2018 Feb 9.

van Deursen AMM, van Houten MA, Webber C, Patton M, Scott DA, Patterson S, Sidhu M, Drews W, Gruber WC, Emini EA, Grobbee DE, Bonten MJM, Sanders EAM. Immunogenicity of the 13-Valent Pneumococcal Conjugate Vaccine in Older Adults With and Without Comorbidities in the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA). Clin Infect Dis. 2017 Sep 1;65(5):787-795. doi: 10.1093/cid/cix419.

Huijts SM, van Werkhoven CH, Bolkenbaas M, Grobbee DE, Bonten MJM. Post-hoc analysis of a randomized controlled trial: Diabetes mellitus modifies the efficacy of the 13-valent pneumococcal conjugate vaccine in elderly. Vaccine. 2017 Aug 3;35(34):4444-4449. doi: 10.1016/j.vaccine.2017.01.071. Epub 2017 Apr 12.

Webber C, Patton M, Patterson S, Schmoele-Thoma B, Huijts SM, Bonten MJ; CAPiTA Study Group. Exploratory efficacy endpoints in the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA). Vaccine. 2017 Mar 1;35(9):1266-1272. doi: 10.1016/j.vaccine.2017.01.032. Epub 2017 Feb 4.

Bonten MJ, Huijts SM, Bolkenbaas M, Webber C, Patterson S, Gault S, van Werkhoven CH, van Deursen AM, Sanders EA, Verheij TJ, Patton M, McDonough A, Moradoghli-Haftvani A, Smith H, Mellelieu T, Pride MW, Crowther G, Schmoele-Thoma B, Scott DA, Jansen KU, Lobatto R, Oosterman B, Visser N, Caspers E, Smorenburg A, Emini EA, Gruber WC, Grobbee DE. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015 Mar 19;372(12):1114-25. doi: 10.1056/NEJMoa1408544.


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00744263 History of Changes
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:


Pneumonia Pneumococcal Infections Pneumonia, Pneumococcal 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

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