Pneumococcal Infections Clinical Trial
— CAPITAOfficial 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
| Verified date | October 2014 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 84496 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Pfizer Investigational Site | Abbekerk | |
| Netherlands | Pfizer Investigational Site | Alkmaar | |
| Netherlands | Pfizer Investigational Site | Alkmaar | |
| Netherlands | Pfizer Investigational Site | Almelo | |
| Netherlands | Pfizer Investigational Site | Almere | |
| Netherlands | Pfizer Investigational Site | Almere | |
| Netherlands | Pfizer Investigational Site | Alphen aan de Rijn | |
| Netherlands | Pfizer Investigational Site | Amersfoort | |
| Netherlands | Pfizer Investigational Site | Amersfoort | |
| Netherlands | Pfizer Investigational Site | Amstelveen | |
| Netherlands | Pfizer Investigational Site | Amstelveen | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Apeldoorn | |
| Netherlands | Pfizer Investigational Site | Apeldoorn | |
| Netherlands | Pfizer Investigational Site | Apeldoorn | |
| Netherlands | Pfizer Investigational Site | Arnhem | |
| Netherlands | Pfizer Investigational Site | Arnhem | |
| Netherlands | Pfizer Investigational Site | Assen | |
| Netherlands | Pfizer Investigational Site | Assen | |
| Netherlands | Pfizer Investigational Site | Baarle-Nassau | |
| Netherlands | Pfizer Investigational Site | Baarn | |
| Netherlands | Pfizer Investigational Site | Bedum | |
| Netherlands | Pfizer Investigational Site | Bennebroek | |
| Netherlands | Pfizer Investigational Site | Bergen op Zoom | |
| Netherlands | Pfizer Investigational Site | Bergen op Zoom | |
| Netherlands | Pfizer Investigational Site | Berkel Enschot | |
| Netherlands | Pfizer Investigational Site | Berkhout | |
| Netherlands | Pfizer Investigational Site | Bilthoven | |
| Netherlands | Pfizer Investigational Site | Blaricum | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Brunssum | |
| Netherlands | Pfizer Investigational Site | Deventer | |
| Netherlands | Pfizer Investigational Site | Deventer | |
| Netherlands | Pfizer Investigational Site | Dongen | |
| Netherlands | Pfizer Investigational Site | Eelde | |
| Netherlands | Pfizer Investigational Site | Eindhoven | |
| Netherlands | Pfizer Investigational Site | Eindhoven | |
| Netherlands | Pfizer Investigational Site | Eindhoven | |
| Netherlands | Pfizer Investigational Site | Eindhoven | |
| Netherlands | Pfizer Investigational Site | Eindhoven | |
| Netherlands | Pfizer Investigational Site | Emmen | |
| Netherlands | Pfizer Investigational Site | Emmen | |
| Netherlands | Pfizer Investigational Site | Enschede | |
| Netherlands | Pfizer Investigational Site | Enschede | |
| Netherlands | Pfizer Investigational Site | Epe | |
| Netherlands | Pfizer Investigational Site | Ettenleur | |
| Netherlands | Pfizer Investigational Site | Fijnaart | |
| Netherlands | Pfizer Investigational Site | Geldrop | |
| Netherlands | Pfizer Investigational Site | Geldrop | |
| Netherlands | Pfizer Investigational Site | Geldrop | |
| Netherlands | Pfizer Investigational Site | Goirle | |
| Netherlands | Pfizer Investigational Site | Gouda | |
| Netherlands | Pfizer Investigational Site | Gouda | |
| Netherlands | Pfizer Investigational Site | Groningen | |
| Netherlands | Pfizer Investigational Site | Groningen | |
| Netherlands | Pfizer Investigational Site | Groningen | |
| Netherlands | Pfizer Investigational Site | Groningen | |
| Netherlands | Pfizer Investigational Site | Grootebroek | |
| Netherlands | Pfizer Investigational Site | Haarlem | |
| Netherlands | Pfizer Investigational Site | Haarlem | |
| Netherlands | Pfizer Investigational Site | Haren | |
| Netherlands | Pfizer Investigational Site | Harmelen | |
| Netherlands | Pfizer Investigational Site | Heerhugowaard | |
| Netherlands | Pfizer Investigational Site | Heerlen | |
| Netherlands | Pfizer Investigational Site | Heerlen | |
| Netherlands | Pfizer Investigational Site | Heiloo | |
| Netherlands | Pfizer Investigational Site | Helmond | |
| Netherlands | Pfizer Investigational Site | Hengelo | |
| Netherlands | Pfizer Investigational Site | Hengelo | |
| Netherlands | Pfizer Investigational Site | Hilvarenbeek | |
| Netherlands | Pfizer Investigational Site | Hilversum | |
| Netherlands | Pfizer Investigational Site | Hilversum | |
| Netherlands | Pfizer Investigational Site | Hoofddorp | |
| Netherlands | Pfizer Investigational Site | Hoogezand | |
| Netherlands | Pfizer Investigational Site | Hoorn | |
| Netherlands | Pfizer Investigational Site | Hoorn | |
| Netherlands | Pfizer Investigational Site | Hoorn | |
| Netherlands | Pfizer Investigational Site | Houten | |
| Netherlands | Pfizer Investigational Site | Kampen | |
| Netherlands | Pfizer Investigational Site | Katwijk | |
| Netherlands | Pfizer Investigational Site | Kerkrade | |
| Netherlands | Pfizer Investigational Site | Leek | |
| Netherlands | Pfizer Investigational Site | Leeuwarden | |
| Netherlands | Pfizer Investigational Site | Leeuwarden | |
| Netherlands | Pfizer Investigational Site | Leiden | |
| Netherlands | Pfizer Investigational Site | Leiden | |
| Netherlands | Pfizer Investigational Site | Leiden | |
| Netherlands | Pfizer Investigational Site | Leiderdorp | |
| Netherlands | Pfizer Investigational Site | Maarssen | |
| Netherlands | Pfizer Investigational Site | Maastricht | |
| Netherlands | Pfizer Investigational Site | Maastricht | |
| Netherlands | Pfizer Investigational Site | Medemblik | |
| Netherlands | Pfizer Investigational Site | Nieuwegein | |
| Netherlands | Pfizer Investigational Site | Nieuwegein | |
| Netherlands | Pfizer Investigational Site | Nijmegen | |
| Netherlands | Pfizer Investigational Site | Nijmegen | |
| Netherlands | Pfizer Investigational Site | Nijmegen | |
| Netherlands | Pfizer Investigational Site | Noordwijk | |
| Netherlands | Pfizer Investigational Site | Oldenzaal | |
| Netherlands | Pfizer Investigational Site | Oosterhout | |
| Netherlands | Pfizer Investigational Site | Peize | |
| Netherlands | Pfizer Investigational Site | Rheden | |
| Netherlands | Pfizer Investigational Site | Riel | |
| Netherlands | Pfizer Investigational Site | Rijsbergen | |
| Netherlands | Pfizer Investigational Site | Rijssen | |
| Netherlands | Pfizer Investigational Site | Roden | |
| Netherlands | Pfizer Investigational Site | Roermond | |
| Netherlands | Pfizer Investigational Site | Roermond | |
| Netherlands | Pfizer Investigational Site | Roermond | |
| Netherlands | Pfizer Investigational Site | Roosendaal | |
| Netherlands | Pfizer Investigational Site | Roosendaal | |
| Netherlands | Pfizer Investigational Site | Schoorl | |
| Netherlands | Pfizer Investigational Site | Simpelveld | |
| Netherlands | Pfizer Investigational Site | Sittard | |
| Netherlands | Pfizer Investigational Site | Sittard | |
| Netherlands | Pfizer Investigational Site | Sleen | |
| Netherlands | Pfizer Investigational Site | Soest | |
| Netherlands | Pfizer Investigational Site | Son | |
| Netherlands | Pfizer Investigational Site | Spaubeek | |
| Netherlands | Pfizer Investigational Site | Steenbergen | |
| Netherlands | Pfizer Investigational Site | Tiel | |
| Netherlands | Pfizer Investigational Site | Tilburg | |
| Netherlands | Pfizer Investigational Site | Tilburg | |
| Netherlands | Pfizer Investigational Site | Tilburg | |
| Netherlands | Pfizer Investigational Site | Tilburg | Noord Brabant |
| Netherlands | Pfizer Investigational Site | Uithoorn | |
| Netherlands | Pfizer Investigational Site | Urmond | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Netherlands | Pfizer Investigational Site | Veldhoven | |
| Netherlands | Pfizer Investigational Site | Veldhoven | |
| Netherlands | Pfizer Investigational Site | Veldhoven | |
| Netherlands | Pfizer Investigational Site | Velp | |
| Netherlands | Pfizer Investigational Site | Venlo | |
| Netherlands | Pfizer Investigational Site | Venlo | |
| Netherlands | Pfizer Investigational Site | Waalwijk | |
| Netherlands | Pfizer Investigational Site | Warmenhuizen | |
| Netherlands | Pfizer Investigational Site | Weert | |
| Netherlands | Pfizer Investigational Site | Woerden | |
| Netherlands | Pfizer Investigational Site | Zeist | |
| Netherlands | Pfizer Investigational Site | Zeist | |
| Netherlands | Pfizer Investigational Site | Zeist | |
| Netherlands | Pfizer Investigational Site | Zevenaar | |
| Netherlands | Pfizer Investigational Site | Zutphen | |
| Netherlands | Pfizer Investigational Site | Zutphen | |
| Netherlands | Pfizer Investigational Site | Zwolle | |
| Netherlands | Pfizer Investigational Site | Zwolle |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination | 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. | Within 7 days after vaccination | Yes |
| Other | Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination | 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. | Within 7 days after vaccination | Yes |
| Other | Percentage of Participants Who Died | Deaths collected throughout the case acquisition period were presented. | 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) | Yes |
| Other | Percentage of Participants With Newly Diagnosed Chronic Medical Condition | Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis. | From 1 month after vaccination up to 6 months after vaccination | Yes |
| Primary | 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) | No |
| Secondary | 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. | 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) | No |
| Secondary | 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). | 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) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02201030 -
Immunogenicity and Safety Study of NBP606 in Healthy Infants
|
Phase 3 | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Completed |
NCT04031846 -
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
|
Phase 3 | |
| Recruiting |
NCT05920499 -
The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage
|
N/A | |
| Completed |
NCT01215175 -
Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)
|
Phase 1 | |
| Completed |
NCT02892812 -
A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults
|
Phase 1 | |
| Completed |
NCT02116998 -
Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae
|
Phase 2 | |
| Completed |
NCT01446926 -
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
|
Phase 1 | |
| Completed |
NCT01193582 -
A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
|
Phase 4 | |
| Completed |
NCT00492557 -
Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
|
Phase 3 | |
| Completed |
NCT00195611 -
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
|
Phase 4 | |
| Completed |
NCT00137605 -
Early Versus Delayed Pneumococcal Vaccination in HIV
|
Phase 1/Phase 2 | |
| Completed |
NCT00205803 -
Study Evaluating Pneumococcal Vaccine in Healthy Infants
|
Phase 1/Phase 2 | |
| Completed |
NCT02531373 -
A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
|
Phase 1/Phase 2 | |
| Completed |
NCT03615482 -
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)
|
Phase 3 | |
| Completed |
NCT03565900 -
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
|
Phase 3 | |
| Completed |
NCT04989465 -
A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine
|
Phase 4 | |
| Completed |
NCT02547649 -
Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)
|
Phase 2 | |
| Completed |
NCT02573181 -
Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)
|
Phase 2 | |
| Completed |
NCT05477693 -
Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine
|
Phase 4 |