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:

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

History of Changes

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 (submitted: October 21, 2010)	Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination [ Time Frame: 30 days after last vaccination ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 Arm (s)	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 *	Not Provided
* 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
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: 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.
Gender	Both
Ages	365 Days to 569 Days
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01226953
Other Study ID Numbers ^ICMJE	V37_07E1
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis ( Novartis Vaccines )
Study Sponsor ^ICMJE	Novartis Vaccines
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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