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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00744263
Other study ID # 6115A1-3006
Secondary ID B1851025
Status Completed
Phase Phase 4
First received August 27, 2008
Last updated October 1, 2014
Start date September 2008
Est. completion date October 2013

Study information

Verified date October 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Biological:
VACCINE: placebo
0.5 mL, single intra-muscular injection
VACCINE: 13-valent pneumococcal conjugate vaccine
0.5 mL, single intra-muscular injection

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

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
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