Back to resultsStudy in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China
Primary Purpose
Haemophilus Influenzae Type b (Hib) Infection
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
Hiberix (Haemophilus influenzae type b (Hib) vaccine)
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, Booster
Eligibility Criteria
Inclusion Criteria:
- Toddlers 12-18 months of age who have previously participated in study M37P2.
Exclusion Criteria:
- Prior Hib booster administration.
- History of serious reaction(s) following vaccination.
- Vaccination within 14 days of study vaccination.
- Known or suspected immune impairment.
- 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 booster
Secondary Outcome Measures
Solicited local and systemic reactions, AEs, and SAEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01025544
Brief Title
Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China
Official Title
A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 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 booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 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, Booster
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
846 (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)
Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
Intervention Description
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
Intervention Type
Biological
Intervention Name(s)
Hiberix (Haemophilus influenzae type b (Hib) vaccine)
Intervention Description
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
Primary Outcome Measure Information:
Title
Anti-PRP antibody levels at day 31 post booster
Time Frame
31 days after vaccination
Secondary Outcome Measure Information:
Title
Solicited local and systemic reactions, AEs, and SAEs
Time Frame
30 days post vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Toddlers 12-18 months of age who have previously participated in study M37P2.
Exclusion Criteria:
Prior Hib booster administration.
History of serious reaction(s) following vaccination.
Vaccination within 14 days of study vaccination.
Known or suspected immune impairment.
For additional entry criteria please refer to the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Basel
Organizational Affiliation
41 61 324 1111
Official's Role
Study Chair
Facility Information:
City
Hebei Province
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China
We'll reach out to this number within 24 hrs