search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
VACCINE: placebo
VACCINE: 13-valent pneumococcal conjugate vaccine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia, Pneumococcal

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

13-valent pneumococcal conjugate vaccine

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).

Full Information

First Posted
August 27, 2008
Last Updated
October 1, 2014
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00744263
Brief Title
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
Acronym
CAPITA
Official Title
A Phase 4, Randomized, Placebo-Controlled Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine Efficacy in Prevention of Vaccine-Serotype Pneumococcal Community-Acquired Pneumonia and Invasive Pneumococcal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumococcal, Pneumococcal Infections, 13-valent Pneumococcal Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84496 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
13-valent pneumococcal conjugate vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
VACCINE: placebo
Intervention Description
0.5 mL, single intra-muscular injection
Intervention Type
Biological
Intervention Name(s)
VACCINE: 13-valent pneumococcal conjugate vaccine
Other Intervention Name(s)
13vPnC
Intervention Description
0.5 mL, single intra-muscular injection
Primary Outcome Measure Information:
Title
Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)
Description
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).
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)
Secondary Outcome Measure Information:
Title
Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)
Description
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.
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)
Title
Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases
Description
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).
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)
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Description
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.
Time Frame
Within 7 days after vaccination
Title
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Description
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.
Time Frame
Within 7 days after vaccination
Title
Percentage of Participants Who Died
Description
Deaths collected throughout the case acquisition period were presented.
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)
Title
Percentage of Participants With Newly Diagnosed Chronic Medical Condition
Description
Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.
Time Frame
From 1 month after vaccination up to 6 months after vaccination

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
29429807
Citation
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.
Results Reference
derived
PubMed Identifier
29017280
Citation
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.
Results Reference
derived
PubMed Identifier
28410813
Citation
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.
Results Reference
derived
PubMed Identifier
28173960
Citation
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.
Results Reference
derived
PubMed Identifier
25785969
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6115A1-3006&StudyName=Study%20Evaluating%20the%20effiacy%20of%20a%2013-Valent%20Pneumococcal%20Conjugate%20Vaccine%20%2813vPnC%29%20in%20Adults
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs