Back to resultsImmunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
Primary Purpose
Haemophilus Influenzae Type b (Hib) Infection
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)
Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
Sponsored by
About this trial
This is an interventional prevention trial for Haemophilus Influenzae Type b (Hib) Infection focused on measuring Haemophilus influenzae type b (Hib), Vaccine, Anti PRP antibody
Eligibility Criteria
Inclusion Criteria:
- Infants 13-59 months of age.
Exclusion Criteria:
- Prior Hib vaccine administration.
- History of serious reaction(s) following vaccination.
- Any vaccination within 7 days of study vaccination.
- Known or suspected immune impairment.
- Premature (before 37th week of gestation) or birth weight less than 2500g
- For additional entry criteria please refer to the protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Anti-PRP antibody levels at day 31 post last vaccination
Secondary Outcome Measures
Solicited local and systemic reactions, AEs, and SAEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01125527
Brief Title
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
Official Title
A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilus Influenzae Type b (Hib) Infection
Keywords
Haemophilus influenzae type b (Hib), Vaccine, Anti PRP antibody
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)
Intervention Description
a single dose was administered
Intervention Type
Biological
Intervention Name(s)
Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
Intervention Description
a single dose was administered
Primary Outcome Measure Information:
Title
Anti-PRP antibody levels at day 31 post last vaccination
Time Frame
30 days after last vaccination
Secondary Outcome Measure Information:
Title
Solicited local and systemic reactions, AEs, and SAEs
Time Frame
30 days post last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infants 13-59 months of age.
Exclusion Criteria:
Prior Hib vaccine administration.
History of serious reaction(s) following vaccination.
Any vaccination within 7 days of study vaccination.
Known or suspected immune impairment.
Premature (before 37th week of gestation) or birth weight less than 2500g
For additional entry criteria please refer to the protocol.
Facility Information:
City
Hebei Province
Country
China
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
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