Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
NCT00373958
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy 2-month-old infants.
- Available for the entire study period.
- Previous vaccination with any vaccine before the start of the study.
- Known contraindication to vaccination.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Ferrol, A Coruna
- Santiago de Compostela, A Coruna
- Argentona, Barcelona
- Sabadell, Barcelona
- Sant Adria de Besos, Barcelona
- Sant Cugat del Valles, Barcelona
- Sant Cugat del Valles, Barcelona
- Bilbao, Bizkaia
- Burela, Lugo
- Alcorcon, Madrid
- Fuenlabrada, Madrid
- Getafe, Madrid
- Getafe, Madrid
- Mostoles, Madrid
- Parla, Madrid
- Antequera, Malaga
- Pamplona, Navarra
- Vigo, Pontevedra
- Burjassot, Valencia
- La Eliana, Valencia
- Quart de Poblet, Valencia
- A Coruna,
- Almeria,
- Almeria,
- Almeria,
- Barcelona,
- Barcelona,
- La Coruna,
- Madrid,
- Madrid,
- Malaga,
- Ourense,
- Sevilla,
- Valencia,
- Valencia,
- Valencia,
- Valencia,
- Valencia,
- Valencia,
- Valencia,
- Valencia,
- Fayetteville, Arkansas
- Jonesboro, Arkansas
- Little Rock, Arkansas
- Downey, California
- Fontana, California
- Loma Linda, California
- Paramount, California
- Riverside, California
- Centennial, Colorado
- Norwich, Connecticut
- Tampa, Florida
- Marietta, Georgia
- Woodstock, Georgia
- Chicago, Illinois
- Park Ridge, Illinois
- Overland Park, Kansas
- Bardstown, Kentucky
- Louisville, Kentucky
- Louisville, Kentucky
- Bronx, New York
- Rochester, New York
- Cincinnati, Ohio
- Cleveland, Ohio
- Mason, Ohio
- Latrobe, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburg, Pennsylvania
- Sellersville, Pennsylvania
- Wexford, Pennsylvania
- Charleston, South Carolina
- Jackson, Tennessee
- The Woodlands, Texas
- Murray, Utah
- Provo, Utah
- Richmond, Virginia
- Vienna, Virginia
- Bad Kreuznach,
- Bad Saulgau,
- Bad Sobernheim,
- Berlin,
- Berlin,
- Berlin,
- Berlin,
- Berlin,
- Berlin,
- Birkenfeld,
- Bobingen,
- Bramsche,
- Bretten,
- Cham,
- Ehingen,
- Erlangen,
- Eschwege,
- Flensburg,
- Gau-Odernheim,
- Hamburg,
- Herzogenaurach,
- Hoechberg,
- Kehl,
- Kiel,
- Kleve,
- Krefeld,
- Ludwigshafen,
- Luebeck,
- Mainz,
- Metzingen,
- Minden,
- Muenster,
- Muenster,
- Neumuenster,
- Neumünster,
- Neustadt/Aisch,
- Niebuell,
- Nuernberg,
- Nuernberg,
- Oberkirch,
- Olching,
- Pforzheim,
- Porta Westfalica,
- Ravensburg,
- Tettnang,
- Vellmar,
- Weiden,
- Weilheim,
- Welzheim,
- Wiesbaden,
- Zirndorf,
- Albi,
- Amiens,
- Ancenis,
- Blanquefort,
- Bondues,
- Bordeaux,
- Brest,
- Chalons en champagne,
- Creteil,
- Dijon,
- Draguignan,
- Ecully,
- Essey-les-nancy,
- Floirac,
- Frejus,
- Garges-les-Gonesse,
- Illkirch,
- Joue les tours,
- Le havre,
- Le plessis-trevise,
- Le pontet,
- Les lilas,
- Les sables d'olonne,
- Libourne,
- Lingolsheim,
- Lyon,
- Lyon,
- Marcq en baroeul,
- Maromme,
- Moutiers,
- Nancy,
- Nice,
- Nogent sur marne,
- Nogent-sur-marne,
- Oullins,
- Paris,
- Rouen,
- Strasbourg,
- Strasbourg,
- Thionville,
- Tours,
- Tresses melac,
- Vandoeuvre les nancy,
- Vaulx-en-velin,
- Villeneuve d'ascq,
- Vitry-sur-seine,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine | |||
Official Title ICMJE | A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States | |||
Brief Summary | The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention | |||
Condition ICMJE | Vaccines, Pneumococcal | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 666 | |||
Original Enrollment ICMJE | 640 | |||
Actual Study Completion Date ICMJE | June 2008 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 42 Days to 98 Days (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00373958 | |||
Other Study ID Numbers ICMJE | 6096A1-004 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |