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?
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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 | |||||||