Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults (CAPITA)
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00744263
First received: August 27, 2008
Last updated: April 12, 2013
Last verified: April 2013
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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 first episodes of vaccine-type pneumococcal community-acquired pneumonia in each study arm. [ Time Frame: N/A. Endpoint-driven study. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of first episodes of vaccine-type invasive pneumococcal disease in each study arm. [ Time Frame: /A. Endpoint-driven study. ] [ Designated as safety issue: No ]
- Number of first episodes of nonbacteremic/noninvasive vaccine-type pneumococcal community-acquired pneumonia in each study arm. [ Time Frame: /A. Endpoint-driven study. ] [ Designated as safety issue: No ]
| Enrollment: | 84496 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | August 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744263
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| Netherlands | |
| Pfizer Investigational Site | |
| Baarle-Nassau, Brabant, Netherlands, 5111 BX | |
| Pfizer Investigational Site | |
| Bergen op Zoom, Brabant, Netherlands, 4611 RD | |
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| Berkel Enschot, Brabant, Netherlands, 5056 PP | |
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| Breda, Brabant, Netherlands, 4811 VC | |
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| Dongen, Brabant, Netherlands, 5104 JK | |
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| Ettenleur, Brabant, Netherlands, 4876 AS | |
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| Fijnaart, Brabant, Netherlands, 4793 CB | |
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| Goirle, Brabant, Netherlands, 5051 RJ | |
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| Hilvarenbeek, Brabant, Netherlands, 5081JV | |
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| Oosterhout, Brabant, Netherlands, 4907 AB | |
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| Rijsbergen, Brabant, Netherlands, 4891 XL | |
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| Steenbergen, Brabant, Netherlands, 4651 RN | |
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| Tilburg, Brabant, Netherlands, 5042 AD | |
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| Waalwijk, Brabant, Netherlands, 5141 BM | |
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| Assen, Drenthe, Netherlands, 9406 GT | |
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| Assen, Drenthe, Netherlands, 9401 RK | |
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| Emmen, Drenthe, Netherlands, 7811 HN | |
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| Emmen, Drenthe, Netherlands, 7824 AA | |
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| Sleen, Drenthe, Netherlands, 7841 CE | |
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| Almere, Flevoland, Netherlands, 1315 RA | |
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| Leeuwarden, Friesland, Netherlands, 8934 AD | |
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| Leeuwarden, Friesland, Netherlands, 8915 AC | |
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| Apeldoorn, Gelderland, Netherlands, 7334 DZ | |
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| Apeldoorn, Gelderland, Netherlands, 7336 BA | |
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| Apeldoorn, Gelderland, Netherlands, 7333 NS | |
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| Arnhem, Gelderland, Netherlands, 6815 AD | |
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| Nijmegen, Gelderland, Netherlands, 6525 GA | |
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| Nijmegen, Gelderland, Netherlands, 6532 SZ | |
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| Rheden, Gelderland, Netherlands, 6991 DV | |
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| Tiel, Gelderland, Netherlands, 4002 WP | |
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| Velp, Gelderland, Netherlands, 6883 AW | |
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| Zevenaar, Gelderland, Netherlands, 6903 ZN | |
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| Zutphen, Gelderland, Netherlands, 7207 BA | |
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| Zutphen, Gelderland, Netherlands, 7201 NC | |
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| Bedum, Groningen, Netherlands, 9781 JG | |
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| Eelde, Groningen, Netherlands, 9761 AB | |
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| Haren, Groningen, Netherlands, 9751 ND | |
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| Hoogezand, Groningen, Netherlands, 9601 KE� | |
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| Kampen, Groningen, Netherlands, 8266 AB | |
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| Leek, Groningen, Netherlands, 9351 KP | |
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| Peize, Groningen, Netherlands, 9321 CK | |
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| Roden, Groningen, Netherlands, 9301 JL | |
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| Zwolle, Groningen, Netherlands, 8025 BT | |
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| Abbekerk, Haarlem, Netherlands, 1657 AH | |
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| Alkmaar, Haarlem, Netherlands, 1825 PV | |
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| Bennebroek, Haarlem, Netherlands, 2121 AJ | |
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| Berkhout, Haarlem, Netherlands, 1647 ME | |
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| Grootebroek, Haarlem, Netherlands, 1613 SJ | |
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| Heerhugowaard, Haarlem, Netherlands, 1701 GB | |
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| Heiloo, Haarlem, Netherlands | |
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| Hoorn, Haarlem, Netherlands, 1628 LZ | |
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| Hoorn, Haarlem, Netherlands, 1624 NP | |
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| Medemblik, Haarlem, Netherlands, 1671 CS | |
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| Roosendaal, Haarlem, Netherlands, 4708 HK | |
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| Schoorl, Haarlem, Netherlands, 1871 EE | |
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| Heerlen, Limburg, Netherlands, 6412 CD | |
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| Kerkrade, Limburg, Netherlands, 6461 AL | |
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| Maastricht(Heer), Limburg, Netherlands, 6227 BZ | |
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| Roermond, Limburg, Netherlands, 6043 CV | |
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| Roermond, Limburg, Netherlands, 6043 WD | |
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| Roermond, Limburg, Netherlands, 6042EH | |
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| Simpelveld, Limburg, Netherlands, 6369 AG | |
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| Spaubeek, Limburg, Netherlands, 6176 BE | |
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| Urmond, Limburg, Netherlands, 6129 EL | |
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| Venlo, Limburg, Netherlands, 5911HH | |
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| Venlo, Limburg, Netherlands, 5912 BL | |
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| Weert, Limburg, Netherlands, 6001 BE | |
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| Heerlen, Limurg, Netherlands, 6419 PC | |
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| Maastricht, Limurg, Netherlands, 6229 HX | |
| Pfizer Investigational Site | |
| Sittard-Geleen, Limurg, Netherlands, 6162 BG | |
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| Bergen op Zoom, Noord Brabant, Netherlands, 4624 VT | |
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| Breda, Noord Brabant, Netherlands, 4818 CK | |
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| Breda, Noord Brabant, Netherlands, 4835 ND | |
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| Eindhoven, Noord Brabant, Netherlands, 5600 HK | |
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| Eindhoven, Noord Brabant, Netherlands, 5623 EJ | |
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| Eindhoven, Noord Brabant, Netherlands, 5616 BA | |
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| Eindhoven, Noord Brabant, Netherlands, 5611 ZB | |
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| Eindhoven, Noord Brabant, Netherlands, 5631 BM | |
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| Geldrop, Noord Brabant, Netherlands, 5664 EP | |
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| Geldrop, Noord Brabant, Netherlands, 5664 HV | |
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| Geldrop, Noord Brabant, Netherlands, 5664 EH | |
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| Helmond, Noord Brabant, Netherlands, 5707 HA | |
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| Roosendaal, Noord Brabant, Netherlands, 4700 AZ | |
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| Son, Noord Brabant, Netherlands, 5691 AR | |
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| Tilburg, Noord Brabant, Netherlands, 5022 GC | |
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| Tilburg, Noord Brabant, Netherlands, 5042 AD | |
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| Tilburg, Noord Brabant, Netherlands, 5022 JB | |
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| Veldhoven, Noord Brabant, Netherlands, 5504 DB | |
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| Veldhoven, Noord Brabant, Netherlands, 5500 AA | |
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| Veldhoven, Noord Brabant, Netherlands, 5503 VV | |
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| Alkmaar, Noord Holland, Netherlands, 1815 JD | |
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| Amstelveen, Noord Holland, Netherlands, 1186 DA | |
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| Amstelveen, Noord Holland, Netherlands, 1186 AM | |
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| Amsterdam, Noord Holland, Netherlands, 1105 AZ | |
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| Amsterdam, Noord Holland, Netherlands, 1098 NJ | |
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| Amsterdam, Noord Holland, Netherlands, 1066 EC | |
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| Amsterdam, Noord Holland, Netherlands, 1081 HV | |
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| Amsterdam, Noord Holland, Netherlands, 1061 AE | |
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| Amsterdam, Noord Holland, Netherlands, 1091 AC | |
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| Amsterdam, Noord Holland, Netherlands, 1043 GR | |
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| Blaricum, Noord Holland, Netherlands, 1261 AN | |
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| Haarlem, Noord Holland, Netherlands, 2035 RC | |
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| Hilversum, Noord Holland, Netherlands, 1213 XZ | |
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| Hoofddorp, Noord Holland, Netherlands, 2134 TM | |
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| Hoorn, Noord Holland, Netherlands, 1642 NP | |
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| Uithoorn, Noord Holland, Netherlands, 1422 LE | |
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| Warmenhuizen, Noord Holland, Netherlands, 1749 AK | |
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| Deventer, Overijssel, Netherlands, 7416 SE | |
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| Deventer, Overijssel, Netherlands, 7418 EV | |
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| Enschede, Overijssel, Netherlands, 7512 AD | |
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| Enschede, Overijssel, Netherlands, 7513 ER | |
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| Oldenzaal, Overijssel, Netherlands, 7573 AM | |
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| Rijssen, Overijssel, Netherlands, 7461DA | |
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| Zwolle, Overijssel, Netherlands, 8025 AB | |
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| Zwolle, Overijssel, Netherlands, 8011 JW | |
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| Amersfoort, Utrecht, Netherlands, 3818 ES | |
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| Baarn, Utrecht, Netherlands, 3743 CM | |
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| Bilthoven, Utrecht, Netherlands, 3723 BM | |
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| Harmelen, Utrecht, Netherlands, 3481 EN | |
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| Hilversum, Utrecht, Netherlands, 1217 GP | |
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| Houten, Utrecht, Netherlands, 3995 AA | |
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| Maarssen, Utrecht, Netherlands, 3603 BM | |
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| Nieuwegein, Utrecht, Netherlands, 3439 ML | |
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| Nieuwegein, Utrecht, Netherlands, 3435 CM | |
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| Soest, Utrecht, Netherlands, 3762 BN | |
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| Utrecht Oost/zuid, Utrecht, Netherlands, 3524 SJ | |
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| Woerden, Utrecht, Netherlands, 3447 GN | |
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| Zeist, Utrecht, Netherlands, 3707 HL | |
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| Zeist, Utrecht, Netherlands, 3707 HX | |
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| Alphen aan de Rijn, Zuid Holland, Netherlands, 2402 EP | |
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| Gouda, Zuid Holland, Netherlands, 2803 AH | |
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| Gouda, Zuid Holland, Netherlands, 2803 PL | |
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| Katwijk, Zuid Holland, Netherlands, 2223 BM | |
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| Leiden, Zuid Holland, Netherlands, 2316 XC | |
| Pfizer Investigational Site | |
| Leiden, Zuid Holland, Netherlands, 2334 CK | |
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| Leiden, Zuid Holland, Netherlands, 2333 ZA | |
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| Leiderdorp, Zuid Holland, Netherlands, 2353 GA | |
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| Noordwijk, Zuid Holland, Netherlands, 2202 NS | |
| Pfizer Investigational Site | |
| Almelo, Netherlands, 7609 PP | |
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| Almere, Netherlands, 1355 EA | |
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| Almere, Netherlands, 1315 RA | |
| Pfizer Investigational Site | |
| Amersfoort, Netherlands, 3821 AR | |
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| Arnhem, Netherlands, 6842 CT | |
| Pfizer Investigational Site | |
| Brunssum, Netherlands, 6444 AT | |
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| Enschede, Netherlands, 7521 AG | |
| Pfizer Investigational Site | |
| Epe, Netherlands, 8162 BD | |
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| Groningen, Netherlands, 9713 EC | |
| Pfizer Investigational Site | |
| Groningen, Netherlands, 9733 CA | |
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| Groningen, Netherlands, 9713 GZ | |
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| Groningen, Netherlands, 9728 NT | |
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| Haarlem, Netherlands, 2035 RJ | |
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| Haarlem-Noord, Netherlands, 2035 RC | |
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| Hengelo, Netherlands, 7555 DL | |
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| Nijmegen, Netherlands, 6546 BC | |
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| Riel, Netherlands, 5133 AM | |
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| Sittard, Netherlands, 6131 KJ | |
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| Utrecht, Netherlands, 3565 CE | |
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| Utrecht, Netherlands, 3508 GA | |
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| Utrecht, Netherlands, 3527 CE | |
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| Utrecht, Netherlands, 3582 KE | |
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| Utrecht, Netherlands, 3525 AL | |
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| Zeist, Netherlands, 3703 CD | |
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 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pneumococcal Infections Pneumonia Pneumonia, Pneumococcal Streptococcal Infections Gram-Positive Bacterial Infections |
Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Pneumonia, Bacterial |
ClinicalTrials.gov processed this record on May 23, 2013