Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00688870
First received: May 29, 2008
Last updated: October 31, 2011
Last verified: October 2011
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| Tracking Information | |||||
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| First Received Date ICMJE | May 29, 2008 | ||||
| Last Updated Date | October 31, 2011 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series. [ Time Frame: 1 month after the infant series (7 months of age) ] [ Designated as safety issue: No ] Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
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| Original Primary Outcome Measures ICMJE |
To assess the pneumococcal immune responses induced by 13vPnC relative to those induced by 7vPnC when measured 1 month after the infant series; and to assess safety by incidence rates of injections site reactions, systemic events and adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00688870 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose [ Time Frame: 1 month after toddler dose (16 months of age) ] [ Designated as safety issue: No ] Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
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| Original Secondary Outcome Measures ICMJE |
To assess the pneumococcal immune responses induced by 13vPnC relative to those induced by 7vPnC when measured 1 month after the toddler dose [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan | ||||
| 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 Taiwan | ||||
| Brief Summary | The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator) Primary Purpose: Prevention |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012 Mar 9;30(12):2054-9. Epub 2011 Dec 22. | ||||
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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 | 168 | ||||
| Completion Date | November 2009 | ||||
| Primary Completion Date | March 2009 (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 | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00688870 | ||||
| Other Study ID Numbers ICMJE | 6096A1-3004, B1851005 | ||||
| Has Data Monitoring Committee | No | ||||
| 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 | |||||
| Investigators ICMJE |
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| Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
| Verification Date | October 2011 | ||||
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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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