Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults (CAPITA)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00744263
First received: August 27, 2008
Last updated: October 1, 2014
Last verified: October 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumococcal Pneumococcal Infections 13-valent Pneumococcal Vaccine |
Biological: VACCINE: placebo Biological: VACCINE: 13-valent pneumococcal conjugate vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.
| Enrollment: | 84496 |
| Study Start Date: | September 2008 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744263
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00744263
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Locations
| Netherlands | |
| Pfizer Investigational Site | |
| Tilburg, Noord Brabant, Netherlands, 5022 JB | |
| Pfizer Investigational Site | |
| Abbekerk, Netherlands, 1657 AH | |
| Pfizer Investigational Site | |
| Alkmaar, Netherlands, 1825 PV | |
| Pfizer Investigational Site | |
| Alkmaar, Netherlands, 1815 JD | |
| Pfizer Investigational Site | |
| Almelo, Netherlands, 7609 PP | |
| Pfizer Investigational Site | |
| Almere, Netherlands, 1355 EA | |
| Pfizer Investigational Site | |
| Almere, Netherlands, 1315 RA | |
| 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 DA | |
| Pfizer Investigational Site | |
| Amstelveen, Netherlands, 1186 AM | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1081 HV | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1105 AZ | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1098 NJ | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1061 AE | |
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| Amsterdam, Netherlands, 1043 GR | |
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| Amsterdam, Netherlands, 1091 AC | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1066 EC | |
| Pfizer Investigational Site | |
| Apeldoorn, Netherlands, 7333 NS | |
| Pfizer Investigational Site | |
| Apeldoorn, Netherlands, 7336 BA | |
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| Apeldoorn, Netherlands, 7334 DZ | |
| Pfizer Investigational Site | |
| Arnhem, Netherlands, 6815 AD | |
| Pfizer Investigational Site | |
| Arnhem, Netherlands, 6842 CT | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| Bennebroek, Netherlands, 2121 AJ | |
| Pfizer Investigational Site | |
| Bergen op Zoom, Netherlands, 4624 VT | |
| Pfizer Investigational Site | |
| Bergen op Zoom, Netherlands, 4611 RD | |
| 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 | |
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| Breda, Netherlands, 4818 CK | |
| Pfizer Investigational Site | |
| Breda, Netherlands, 4835 ND | |
| Pfizer Investigational Site | |
| Breda, Netherlands, 4811 VC | |
| 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, 5611 ZB | |
| Pfizer Investigational Site | |
| Eindhoven, Netherlands, 5631 BM | |
| Pfizer Investigational Site | |
| Eindhoven, Netherlands, 5616 BA | |
| Pfizer Investigational Site | |
| Eindhoven, Netherlands, 5600 HK | |
| Pfizer Investigational Site | |
| Eindhoven, Netherlands, 5623 EJ | |
| Pfizer Investigational Site | |
| Emmen, Netherlands, 7824 AA | |
| Pfizer Investigational Site | |
| Emmen, Netherlands, 7811 HN | |
| Pfizer Investigational Site | |
| Enschede, Netherlands, 7521 AG | |
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| Enschede, Netherlands, 7513 ER | |
| Pfizer Investigational Site | |
| 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 PL | |
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| Gouda, Netherlands, 2803 AH | |
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| Groningen, Netherlands, 9733 CA | |
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| Groningen, Netherlands, 9713 EC | |
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| Groningen, Netherlands, 9728 NT | |
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| Groningen, Netherlands, 9713 GZ | |
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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, 6419 PC | |
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| Heerlen, Netherlands, 6412 CD | |
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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 | |
| Pfizer Investigational Site | |
| Hilversum, Netherlands, 1217 GP | |
| Pfizer Investigational Site | |
| Hilversum, Netherlands, 1213 XZ | |
| Pfizer Investigational Site | |
| Hoofddorp, Netherlands, 2134 TM | |
| Pfizer Investigational Site | |
| Hoogezand, Netherlands, 9601 KE� | |
| Pfizer Investigational Site | |
| Hoorn, Netherlands, 1628 LZ | |
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| Hoorn, Netherlands, 1624 NP | |
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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 | |
| Pfizer Investigational Site | |
| Nieuwegein, Netherlands, 3439 ML | |
| Pfizer Investigational Site | |
| Nieuwegein, Netherlands, 3435 CM | |
| Pfizer Investigational Site | |
| Nijmegen, Netherlands, 6532 SZ | |
| Pfizer Investigational Site | |
| Nijmegen, Netherlands, 6525 GA | |
| Pfizer Investigational Site | |
| Nijmegen, Netherlands, 6546 BC | |
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| Noordwijk, Netherlands, 2202 NS | |
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| 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 | |
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| Roden, Netherlands, 9301 JL | |
| Pfizer Investigational Site | |
| Roermond, Netherlands, 6042EH | |
| Pfizer Investigational Site | |
| Roermond, Netherlands, 6043 CV | |
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| Roermond, Netherlands, 6043 WD | |
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| 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 | |
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| Steenbergen, Netherlands, 4651 RN | |
| Pfizer Investigational Site | |
| Tiel, Netherlands, 4002 WP | |
| Pfizer Investigational Site | |
| Tilburg, Netherlands, 5022 JB | |
| Pfizer Investigational Site | |
| Tilburg, Netherlands, 5042 AD | |
| Pfizer Investigational Site | |
| Tilburg, Netherlands, 5022 GC | |
| Pfizer Investigational Site | |
| Uithoorn, Netherlands, 1422 LE | |
| Pfizer Investigational Site | |
| Urmond, Netherlands, 6129 EL | |
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| Utrecht, Netherlands, 3582 KE | |
| Pfizer Investigational Site | |
| Utrecht, Netherlands, 3525 AL | |
| Pfizer Investigational Site | |
| Utrecht, Netherlands, 3508 GA | |
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| Utrecht, Netherlands, 3565 CE | |
| Pfizer Investigational Site | |
| Utrecht, Netherlands, 3524 SJ | |
| Pfizer Investigational Site | |
| Utrecht, Netherlands, 3527 CE | |
| Pfizer Investigational Site | |
| Veldhoven, Netherlands, 5503 VV | |
| Pfizer Investigational Site | |
| Veldhoven, Netherlands, 5504 DB | |
| Pfizer Investigational Site | |
| Veldhoven, Netherlands, 5500 AA | |
| 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, 3707 HL | |
| Pfizer Investigational Site | |
| Zeist, Netherlands, 3703 CD | |
| Pfizer Investigational Site | |
| Zeist, Netherlands, 3707 HX | |
| Pfizer Investigational Site | |
| Zevenaar, Netherlands, 6903 ZN | |
| Pfizer Investigational Site | |
| Zutphen, Netherlands, 7207 BA | |
| Pfizer Investigational Site | |
| Zutphen, Netherlands, 7201 NC | |
| 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:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00744263 History of Changes |
| Other Study ID Numbers: | 6115A1-3006, B1851025 |
| Study First Received: | August 27, 2008 |
| Results First Received: | October 1, 2014 |
| Last Updated: | October 1, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pneumococcal Infections Pneumonia, Pneumococcal Bacterial Infections Gram-Positive Bacterial Infections Lung Diseases |
Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections |
ClinicalTrials.gov processed this record on February 27, 2015