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Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01226953
First received: October 21, 2010
Last updated: December 27, 2011
Last verified: December 2011
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | October 21, 2010 | ||
| Last Updated Date | December 27, 2011 | ||
| Start Date ICMJE | October 2010 | ||
| Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination [ Time Frame: 30 days after last vaccination ] | ||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | Complete list of historical versions of study NCT01226953 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE |
Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) [ Time Frame: 30 days post last vaccination ] | ||
| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants | ||
| Official Title ICMJE | A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants | ||
| Brief Summary | This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Haemophilus Influenzae Type b (Hib) Infection | ||
| Intervention ICMJE | Biological: Haemophilus influenzae type b (Hib) vaccine
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines |
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| Study Arms |
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| Publications * | Jun L, Yuguo C, Zhiguo W, Jinfeng L, Huawei M, Xiuhua L, Yonggui Z, Yanhua X, Kong Y, Hongtao L, Yuliang Z. Assessment of immunogenicity and safety following primary and booster immunisation with a CRM197 -conjugated Haemophilus influenzae type B vaccine in healthy Chinese infants. Int J Clin Pract. 2013 Oct;67(10):971-8. doi: 10.1111/ijcp.12267. Epub 2013 Aug 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 | 660 | ||
| Completion Date | March 2011 | ||
| Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 365 Days to 569 Days (Child) | ||
| Accepts Healthy Volunteers | Yes | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | China | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01226953 | ||
| Other Study ID Numbers ICMJE | V37_07E1 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Novartis ( Novartis Vaccines ) | ||
| Study Sponsor ICMJE | Novartis Vaccines | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Novartis | ||
| Verification Date | December 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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