Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

Tracking Information
First Submitted Date ICMJE	October 21, 2010
First Posted Date ICMJE	October 22, 2010
Last Update Posted Date	December 30, 2011
Study Start Date ICMJE	October 2010
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 21, 2010)	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; (submitted: October 21, 2010)	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
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
Study Arms	Active Comparator: Arm 1 Intervention: Biological: Haemophilus influenzae type b (Hib) vaccine; Active Comparator: Arm 2 Intervention: Biological: Haemophilus influenzae type b (Hib) vaccine
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.
* 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; (submitted: December 13, 2010)	660
Original Estimated Enrollment ICMJE; (submitted: October 21, 2010)	670
Actual Study Completion Date	March 2011
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Infants 365-569 days of age. Exclusion Criteria: Subjects who already received a booster dose of Hib vaccine.; History of serious reaction(s) following vaccination.; Any vaccination within 7 days of study vaccination.; Known or suspected immune impairment.
Sex/Gender	Sexes Eligible for Study: All
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
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP