Pneumonia, PneumococcalPhase 4CAPITANCT00744263

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

A Phase 4 study testing VACCINE: 13-valent pneumococcal conjugate vaccine in people with Pneumonia, Pneumococcal and Pneumococcal Infections, run by Pfizer at 159 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumonia, Pneumococcal, Pneumococcal Infections, 13-valent Pneumococcal Vaccine
What is being tested?: VACCINE: 13-valent pneumococcal conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84,496 participants
Where: 159 sitesNetherlands
Study dates: Sep 2008to Oct 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

159 sites in 1 country.

City, postcode or hospital

159 sites in 1 country

Netherlands159 sites

Pfizer Investigational Site
Abbekerk, 1657 AH
Pfizer Investigational Site
Alkmaar, 1815 JD
Pfizer Investigational Site
Alkmaar, 1825 PV
Pfizer Investigational Site
Almelo, 7609 PP
Pfizer Investigational Site
Almere Stad, 1315 RA
Pfizer Investigational Site
Almere Stad, 1355 EA
Pfizer Investigational Site
Alphen aan den Rijn, 2402 EP
Pfizer Investigational Site
Amersfoort, 3813 TZ
Pfizer Investigational Site
Amersfoort, 3821 AR
Pfizer Investigational Site
Amstelveen, 1186 AM
Pfizer Investigational Site
Amstelveen, 1186 DA
Pfizer Investigational Site
Amsterdam, 1043 GR
Pfizer Investigational Site
Amsterdam, 1061 AE
Pfizer Investigational Site
Amsterdam, 1066 EC
Pfizer Investigational Site
Amsterdam, 1081 HV
Pfizer Investigational Site
Amsterdam, 1091 AC
Pfizer Investigational Site
Amsterdam, 1098 NJ
Pfizer Investigational Site
Amsterdam, 1105 AZ
Pfizer Investigational Site
Apeldoorn, 7333 NS
Pfizer Investigational Site
Apeldoorn, 7334 DZ
Pfizer Investigational Site
Apeldoorn, 7336 BA
Pfizer Investigational Site
Arnhem, 6815 AD
Pfizer Investigational Site
Arnhem, 6842 CT
Pfizer Investigational Site
Assen, 9401 RK
Pfizer Investigational Site
Assen, 9406 GT
Pfizer Investigational Site
Baarle-Nassau, 5111 BX
Pfizer Investigational Site
Baarn, 3743 CM
Pfizer Investigational Site
Bedum, 9781 JG
Pfizer Investigational Site
Bennebroek, 2121 AJ
Pfizer Investigational Site
Bergen op Zoom, 4611 RD
Pfizer Investigational Site
Bergen op Zoom, 4624 VT
Pfizer Investigational Site
Berkel-Enschot, 5056 PP
Pfizer Investigational Site
Berkhout, 1647 ME
Pfizer Investigational Site
Bilthoven, 3723 BM
Pfizer Investigational Site
Blaricum, 1261 AN
Pfizer Investigational Site
Breda, 4811 VC
Pfizer Investigational Site
Breda, 4818 CK
Pfizer Investigational Site
Breda, 4835 ND
Pfizer Investigational Site
Brunssum, 6444 AT
Pfizer Investigational Site
Deventer, 7416 SE
Pfizer Investigational Site
Deventer, 7418 EV
Pfizer Investigational Site
Dongen, 5104 JK
Pfizer Investigational Site
Eelde, 9761 AB
Pfizer Investigational Site
Eindhoven, 5600 HK
Pfizer Investigational Site
Eindhoven, 5611 ZB
Pfizer Investigational Site
Eindhoven, 5616 BA
Pfizer Investigational Site
Eindhoven, 5623 EJ
Pfizer Investigational Site
Eindhoven, 5631 BM
Pfizer Investigational Site
Emmen, 7811 HN
Pfizer Investigational Site
Emmen, 7824 AA
Pfizer Investigational Site
Enschede, 7513 ER
Pfizer Investigational Site
Enschede, 7521 AG
Pfizer Investigational Site
Epe, 8162 BD
Pfizer Investigational Site
Ettenleur, 4876 AS
Pfizer Investigational Site
Fijnaart, 4793 CB
Pfizer Investigational Site
Geldrop, 5664 EH
Pfizer Investigational Site
Geldrop, 5664 EP
Pfizer Investigational Site
Geldrop, 5664 HV
Pfizer Investigational Site
Goirle, 5051 RJ
Pfizer Investigational Site
Gouda, 2803 AH
Pfizer Investigational Site
Gouda, 2803 PL
Pfizer Investigational Site
Groningen, 9713 EC
Pfizer Investigational Site
Groningen, 9713 GZ
Pfizer Investigational Site
Groningen, 9728 NT
Pfizer Investigational Site
Groningen, 9733 CA
Pfizer Investigational Site
Grootebroek, 1613 SJ
Pfizer Investigational Site
Haarlem, 2035 RC
Pfizer Investigational Site
Haarlem, 2035 RJ
Pfizer Investigational Site
Haren, 9751 ND
Pfizer Investigational Site
Harmelen, 3481 EN
Pfizer Investigational Site
Heerhugowaard, 1701 GB
Pfizer Investigational Site
Heerlen, 6412 CD
Pfizer Investigational Site
Heerlen, 6419 PC
Pfizer Investigational Site
Heiloo
Pfizer Investigational Site
Helmond, 5707 HA
Pfizer Investigational Site
Hengelo, 7555 BB
Pfizer Investigational Site
Hengelo, 7555 DL
Pfizer Investigational Site
Hilvarenbeek, 5081JV
Pfizer Investigational Site
Hilversum, 1213 XZ
Pfizer Investigational Site
Hilversum, 1217 GP
Pfizer Investigational Site
Hoofddorp, 2134 TM
Pfizer Investigational Site
Hoogezand, 9601 KE�
Pfizer Investigational Site
Hoorn, 1624 NP
Pfizer Investigational Site
Hoorn, 1628 LZ
Pfizer Investigational Site
Hoorn, 1642 NP
Pfizer Investigational Site
Houten, 3995 AA
Pfizer Investigational Site
Kampen, 8266 AB
Pfizer Investigational Site
Katwijk, 2223 BM
Pfizer Investigational Site
Kerkrade, 6461 AL
Pfizer Investigational Site
Leek, 9351 KP
Pfizer Investigational Site
Leeuwarden, 8915 AC
Pfizer Investigational Site
Leeuwarden, 8934 AD
Pfizer Investigational Site
Leiden, 2316 XC
Pfizer Investigational Site
Leiden, 2333 ZA
Pfizer Investigational Site
Leiden, 2334 CK
Pfizer Investigational Site
Leiderdorp, 2353 GA
Pfizer Investigational Site
Maarssen, 3603 BM
Pfizer Investigational Site
Maastricht, 6227 BZ
Pfizer Investigational Site
Maastricht, 6229 HX
Pfizer Investigational Site
Medemblik, 1671 CS
Pfizer Investigational Site
Nieuwegein, 3435 CM
Pfizer Investigational Site
Nieuwegein, 3439 ML
Pfizer Investigational Site
Nijmegen, 6525 GA
Pfizer Investigational Site
Nijmegen, 6532 SZ
Pfizer Investigational Site
Nijmegen, 6546 BC
Pfizer Investigational Site
Noordwijk, 2202 NS
Pfizer Investigational Site
Oldenzaal, 7573 AM
Pfizer Investigational Site
Oosterhout, 4907 AB
Pfizer Investigational Site
Peize, 9321 CK
Pfizer Investigational Site
Rheden, 6991 DV
Pfizer Investigational Site
Riel, 5133 AM
Pfizer Investigational Site
Rijsbergen, 4891 XL
Pfizer Investigational Site
Rijssen, 7461DA
Pfizer Investigational Site
Roden, 9301 JL
Pfizer Investigational Site
Roermond, 6042EH
Pfizer Investigational Site
Roermond, 6043 CV
Pfizer Investigational Site
Roermond, 6043 WD
Pfizer Investigational Site
Roosendaal, 4700 AZ
Pfizer Investigational Site
Roosendaal, 4708 HK
Pfizer Investigational Site
Schoorl, 1871 EE
Pfizer Investigational Site
Simpelveld, 6369 AG
Pfizer Investigational Site
Sittard, 6131 KJ
Pfizer Investigational Site
Sittard, 6162 BG
Pfizer Investigational Site
Sleen, 7841 CE
Pfizer Investigational Site
Soest, 3762 BN
Pfizer Investigational Site
Son, 5691 AR
Pfizer Investigational Site
Spaubeek, 6176 BE
Pfizer Investigational Site
Steenbergen, 4651 RN
Pfizer Investigational Site
Tiel, 4002 WP
Pfizer Investigational Site
Tilburg, North Brabant, 5022 JB
Pfizer Investigational Site
Tilburg, 5022 GC
Pfizer Investigational Site
Tilburg, 5022 JB
Pfizer Investigational Site
Tilburg, 5042 AD
Pfizer Investigational Site
Uithoorn, 1422 LE
Pfizer Investigational Site
Urmond, 6129 EL
Pfizer Investigational Site
Utrecht, 3508 GA
Pfizer Investigational Site
Utrecht, 3524 SJ
Pfizer Investigational Site
Utrecht, 3525 AL
Pfizer Investigational Site
Utrecht, 3527 CE
Pfizer Investigational Site
Utrecht, 3565 CE
Pfizer Investigational Site
Utrecht, 3582 KE
Pfizer Investigational Site
Veldhoven, 5500 AA
Pfizer Investigational Site
Veldhoven, 5503 VV
Pfizer Investigational Site
Veldhoven, 5504 DB
Pfizer Investigational Site
Velp, 6883 AW
Pfizer Investigational Site
Venlo, 5911HH
Pfizer Investigational Site
Venlo, 5912 BL
Pfizer Investigational Site
Waalwijk, 5141 BM
Pfizer Investigational Site
Warmenhuizen, 1749 AK
Pfizer Investigational Site
Weert, 3001 BE
Pfizer Investigational Site
Woerden, 3447 GN
Pfizer Investigational Site
Zeist, 3703 CD
Pfizer Investigational Site
Zeist, 3707 HL
Pfizer Investigational Site
Zeist, 3707 HX
Pfizer Investigational Site
Zevenaar, 6903 ZN
Pfizer Investigational Site
Zutphen, 7201 NC
Pfizer Investigational Site
Zutphen, 7207 BA
Pfizer Investigational Site
Zwolle, 8025 AB
Pfizer Investigational Site
Zwolle, 8025 BT

Other trials in Netherlands

About this study

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

Conditions: Pneumonia, Pneumococcal, Pneumococcal Infections, 13-valent Pneumococcal Vaccine
Being tested: VACCINE: placebo, VACCINE: 13-valent pneumococcal conjugate vaccine
Medical subject headings: Pneumonia, Pneumococcal, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VACCINE: placeboBiological
0.5 mL, single intra-muscular injection
VACCINE: 13-valent pneumococcal conjugate vaccineBiological
Also called 13vPnC
0.5 mL, single intra-muscular injection

Study groups in NCT00744263
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Biological: VACCINE: placebo
13-valent pneumococcal conjugate vaccine	Experimental	Not described Receives: Biological: VACCINE: 13-valent pneumococcal conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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)
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.
Measured: 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
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).
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Oct 2013

First posted29 Aug 2008 (estimated)
Study startSep 2008
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Pneumonia, PneumococcalStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 84,496 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00744263
Sponsor's protocol ID: 6115A1-3006
Other IDs: B1851025
Acronym: CAPITA
Status last verified: Oct 2014
First submitted: 27 Aug 2008
Last updated: 6 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 29429807
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.
PubMed 29017280
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.
PubMed 28410813
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.
PubMed 28173960
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.
PubMed 25785969

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00744263
Acronym / sponsor ID: CAPITA / 6115A1-3006
Conditions: Pneumonia, Pneumococcal, Pneumococcal Infections, 13-valent Pneumococcal Vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 84,496 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 29 Aug 2008 (estimated)
Results: Posted 6 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Biological: VACCINE: placebo
13-valent pneumococcal conjugate vaccine	Experimental	Biological: VACCINE: 13-valent pneumococcal conjugate vaccine

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VACCINE: placebo0.5 mL, single intra-muscular injection	Biological	Placebo
VACCINE: 13-valent pneumococcal conjugate vaccineAlso: 13vPnC0.5 mL, single intra-muscular injection	Biological	13-valent pneumococcal conjugate vaccine

Primary outcome

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).

2 secondary outcomes

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)
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)

Results and safety

Results posted to the registry on 6 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC	42,240	37,004
Placebo	42,256	36,936

Primary outcome: 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). Number. Unit: participants

Measure	13vPnC n = 42240	Placebo n = 42256
Value	49	90

13vPnC vs Placebo: Vaccine Efficacy: 45.56 (95.2% CI 21.82 to 62.49), p = 0.0006, Clopper-Pearson method

Population analysed: Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Safety Set	327 of 42,237 (0.8%)	0 of 0	Not reported
Placebo Safety Set	314 of 42,255 (0.7%)	0 of 0	Not reported
13vPnC Immunogenicity Subset	55 of 1,006 (5.5%)	363 of 1,006 (36.1%)	Not reported
Placebo Immunogenicity Subset	48 of 1,005 (4.8%)	315 of 1,005 (31.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29429807Suaya 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.
Derived from this study: PubMed 29017280van 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.
Derived from this study: PubMed 28410813Huijts 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.
Derived from this study: PubMed 28173960Webber 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.
Derived from this study: PubMed 25785969Bonten 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

159 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing VACCINE: 13-valent pneumococcal conjugate vaccine in people with Pneumonia, Pneumococcal and Pneumococcal Infections, run by Pfizer at 159 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00744263, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014.