Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
NCT00368966
Last updated date
ABOUT THIS STUDY
The purpose of this study is to assess the safety, tolerability and immunogenicity of a
13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
concomitantly with routine pediatric vaccinations in Spain.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Pneumococcal
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
42-98 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Healthy 2-month-old infants
- Available for the entire study period
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
Vaccines, PneumococcalStudy to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
NCT00368966
- 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,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Vaccines, PneumococcalStudy Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
NCT00373958
- 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
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Vaccines, PneumococcalStudy to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
NCT00366340
- 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,
ALL GENDERS
56 Days+
years
MULTIPLE SITES
Vaccines, PneumococcalStudy to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
NCT00366678
- 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,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. | ||||||
| Official Title ICMJE | A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain | ||||||
| Brief Summary | The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations in Spain. | ||||||
| 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 | 619 | ||||||
| Original Enrollment ICMJE | 600 | ||||||
| Actual Study Completion Date ICMJE | July 2008 | ||||||
| Actual Primary Completion Date | July 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 | Spain | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00368966 | ||||||
| Other Study ID Numbers ICMJE | 6096A1-501 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Verification Date | July 2012 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||