Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00508742
First received: July 26, 2007
Last updated: May 6, 2013
Last verified: May 2013
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| Tracking Information | |||||
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| First Received Date ICMJE | July 26, 2007 | ||||
| Last Updated Date | May 6, 2013 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age [ Time Frame: Month 7 through Month 24 ] [ Designated as safety issue: No ] A new acquisition was defined as the detection of a serotype (here 6A' [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age. |
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| Original Primary Outcome Measures ICMJE |
Primary comparison is culture findings in subjects receiving 13vPnC relative to those receiving 7vPnC. Primary endpoint is proportion of subjects with a new acquisition of either serotype 6A or 19A 1 month after the infant series to 24 months of age. | ||||
| Change History | Complete list of historical versions of study NCT00508742 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age [ Time Frame: Month 7, 12, 13, 18, 24 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Secondary endpoints are the proportion of cultures testing positive for serotypes 6A or 19A of s. pneumoniae as a group measured at 18 months of age and from 1 month after the infant series to 24 months of age. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization | ||||
| Official Title ICMJE | A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Infants in Israel. | ||||
| Brief Summary | This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Pneumococcal Infections | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1866 | ||||
| Completion Date | August 2011 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 42 Days to 98 Days | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00508742 | ||||
| Other Study ID Numbers ICMJE | 6096A1-3006, B1851007 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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