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

• Sponsor: Pfizer
• 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

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 :

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

• 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

  Hide Study Locations

Locations

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

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

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
• 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