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

NCT00744263 | Completed Phase 4 Results DMC

• 2 other identifiers: 6115A1-3006B1851025
• Study Type: interventional
• Target: 84,496
• Locations: 1 country
• Sites: 159

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.

Conditions

Pneumonia, Pneumococcal; Pneumococcal Infections; 13-valent Pneumococcal Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)

  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).

  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)

Secondary Outcomes (2)

• Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)

  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)

• Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases

  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)

Other Outcomes (4)

• Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination

  Within 7 days after vaccination

• Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination

  Within 7 days after vaccination

• Percentage of Participants Who Died

  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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Biological: VACCINE: placebo

13-valent pneumococcal conjugate vaccine

EXPERIMENTAL

Biological: VACCINE: 13-valent pneumococcal conjugate vaccine

Interventions

VACCINE: placebo BIOLOGICAL

0.5 mL, single intra-muscular injection

Placebo

VACCINE: 13-valent pneumococcal conjugate vaccine BIOLOGICAL

0.5 mL, single intra-muscular injection

Also known as: 13vPnC

13-valent pneumococcal conjugate vaccine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (159)

Pfizer Investigational Site

Tilburg, North Brabant, 5022 JB, Netherlands

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Abbekerk, 1657 AH, Netherlands

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Alkmaar, 1815 JD, Netherlands

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Alkmaar, 1825 PV, Netherlands

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Almelo, 7609 PP, Netherlands

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Almere Stad, 1315 RA, Netherlands

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Almere Stad, 1355 EA, Netherlands

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Alphen aan den Rijn, 2402 EP, Netherlands

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Amersfoort, 3813 TZ, Netherlands

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Amersfoort, 3821 AR, Netherlands

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Amstelveen, 1186 AM, Netherlands

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Amstelveen, 1186 DA, Netherlands

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Amsterdam, 1043 GR, Netherlands

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Amsterdam, 1061 AE, Netherlands

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Amsterdam, 1066 EC, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Amsterdam, 1091 AC, Netherlands

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Amsterdam, 1098 NJ, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Apeldoorn, 7333 NS, Netherlands

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Apeldoorn, 7334 DZ, Netherlands

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Apeldoorn, 7336 BA, Netherlands

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Arnhem, 6815 AD, Netherlands

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Arnhem, 6842 CT, Netherlands

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Assen, 9401 RK, Netherlands

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Assen, 9406 GT, Netherlands

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Baarle-Nassau, 5111 BX, Netherlands

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Baarn, 3743 CM, Netherlands

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Bedum, 9781 JG, Netherlands

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Bennebroek, 2121 AJ, Netherlands

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Bergen op Zoom, 4611 RD, Netherlands

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Bergen op Zoom, 4624 VT, Netherlands

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Berkel-Enschot, 5056 PP, Netherlands

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Berkhout, 1647 ME, Netherlands

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Bilthoven, 3723 BM, Netherlands

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Blaricum, 1261 AN, Netherlands

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Breda, 4811 VC, Netherlands

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Breda, 4818 CK, Netherlands

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Breda, 4835 ND, Netherlands

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Brunssum, 6444 AT, Netherlands

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Deventer, 7416 SE, Netherlands

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Deventer, 7418 EV, Netherlands

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Dongen, 5104 JK, Netherlands

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Eelde, 9761 AB, Netherlands

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Eindhoven, 5600 HK, Netherlands

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Eindhoven, 5611 ZB, Netherlands

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Eindhoven, 5616 BA, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Eindhoven, 5631 BM, Netherlands

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Emmen, 7811 HN, Netherlands

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Emmen, 7824 AA, Netherlands

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Enschede, 7513 ER, Netherlands

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Enschede, 7521 AG, Netherlands

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Epe, 8162 BD, Netherlands

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Ettenleur, 4876 AS, Netherlands

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Fijnaart, 4793 CB, Netherlands

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Geldrop, 5664 EH, Netherlands

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Geldrop, 5664 EP, Netherlands

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Geldrop, 5664 HV, Netherlands

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Goirle, 5051 RJ, Netherlands

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Gouda, 2803 AH, Netherlands

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Gouda, 2803 PL, Netherlands

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Groningen, 9713 EC, Netherlands

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Groningen, 9713 GZ, Netherlands

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Groningen, 9728 NT, Netherlands

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Groningen, 9733 CA, Netherlands

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Grootebroek, 1613 SJ, Netherlands

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Haarlem, 2035 RC, Netherlands

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Haarlem, 2035 RJ, Netherlands

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Haren, 9751 ND, Netherlands

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Harmelen, 3481 EN, Netherlands

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Heerhugowaard, 1701 GB, Netherlands

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Heerlen, 6412 CD, Netherlands

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Heerlen, 6419 PC, Netherlands

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Heiloo, Netherlands

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Helmond, 5707 HA, Netherlands

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Hengelo, 7555 BB, Netherlands

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Hengelo, 7555 DL, Netherlands

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Hilvarenbeek, 5081JV, Netherlands

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Hilversum, 1213 XZ, Netherlands

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Hilversum, 1217 GP, Netherlands

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Hoofddorp, 2134 TM, Netherlands

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Hoogezand, 9601 KE�, Netherlands

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Hoorn, 1624 NP, Netherlands

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Hoorn, 1628 LZ, Netherlands

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Hoorn, 1642 NP, Netherlands

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Houten, 3995 AA, Netherlands

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Kampen, 8266 AB, Netherlands

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Katwijk, 2223 BM, Netherlands

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Kerkrade, 6461 AL, Netherlands

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Leek, 9351 KP, Netherlands

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Leeuwarden, 8915 AC, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Leiden, 2316 XC, Netherlands

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Leiden, 2333 ZA, Netherlands

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Leiden, 2334 CK, Netherlands

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Leiderdorp, 2353 GA, Netherlands

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Maarssen, 3603 BM, Netherlands

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Maastricht, 6227 BZ, Netherlands

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Maastricht, 6229 HX, Netherlands

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Medemblik, 1671 CS, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Nieuwegein, 3439 ML, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Nijmegen, 6546 BC, Netherlands

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Noordwijk, 2202 NS, Netherlands

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Oldenzaal, 7573 AM, Netherlands

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Oosterhout, 4907 AB, Netherlands

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Peize, 9321 CK, Netherlands

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Rheden, 6991 DV, Netherlands

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Riel, 5133 AM, Netherlands

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Rijsbergen, 4891 XL, Netherlands

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Rijssen, 7461DA, Netherlands

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Roden, 9301 JL, Netherlands

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Roermond, 6042EH, Netherlands

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Roermond, 6043 CV, Netherlands

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Roermond, 6043 WD, Netherlands

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Roosendaal, 4700 AZ, Netherlands

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Roosendaal, 4708 HK, Netherlands

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Schoorl, 1871 EE, Netherlands

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Simpelveld, 6369 AG, Netherlands

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Sittard, 6131 KJ, Netherlands

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Sittard, 6162 BG, Netherlands

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Sleen, 7841 CE, Netherlands

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Soest, 3762 BN, Netherlands

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Son, 5691 AR, Netherlands

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Spaubeek, 6176 BE, Netherlands

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Steenbergen, 4651 RN, Netherlands

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Tiel, 4002 WP, Netherlands

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Tilburg, 5022 GC, Netherlands

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Tilburg, 5022 JB, Netherlands

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Tilburg, 5042 AD, Netherlands

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Uithoorn, 1422 LE, Netherlands

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Urmond, 6129 EL, Netherlands

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Utrecht, 3508 GA, Netherlands

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Utrecht, 3524 SJ, Netherlands

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Utrecht, 3525 AL, Netherlands

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Utrecht, 3527 CE, Netherlands

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Utrecht, 3565 CE, Netherlands

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Utrecht, 3582 KE, Netherlands

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Veldhoven, 5500 AA, Netherlands

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Veldhoven, 5503 VV, Netherlands

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Veldhoven, 5504 DB, Netherlands

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Velp, 6883 AW, Netherlands

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Venlo, 5911HH, Netherlands

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Venlo, 5912 BL, Netherlands

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Waalwijk, 5141 BM, Netherlands

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Warmenhuizen, 1749 AK, Netherlands

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Weert, 3001 BE, Netherlands

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Woerden, 3447 GN, Netherlands

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Zeist, 3703 CD, Netherlands

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Zeist, 3707 HL, Netherlands

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Zeist, 3707 HX, Netherlands

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Zevenaar, 6903 ZN, Netherlands

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Zutphen, 7201 NC, Netherlands

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Zutphen, 7207 BA, Netherlands

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Zwolle, 8025 AB, Netherlands

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Zwolle, 8025 BT, Netherlands

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Related Publications (5)

• 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.

  PMID: 29429807 DERIVED

• 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.

  PMID: 29017280 DERIVED

• 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.

  PMID: 28410813 DERIVED

• 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.

  PMID: 28173960 DERIVED

• 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.

  PMID: 25785969 DERIVED

Related Links

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

MeSH Terms

Conditions

Pneumonia, Pneumococcal; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 6, 2014
• Results First Posted: October 6, 2014

Record last verified: 2014-10

Locations

NL (159)