Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants
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
1 other identifier
interventional
660
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
October 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedDecember 30, 2011
December 1, 2011
2 months
October 21, 2010
December 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination
30 days after last vaccination
Secondary Outcomes (1)
Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs)
30 days post last vaccination
Study Arms (2)
Arm 1
ACTIVE COMPARATORArm 2
ACTIVE COMPARATORInterventions
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines
Eligibility Criteria
You may qualify if:
- Infants 365-569 days of age.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Hebei Province, China
Related Publications (1)
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.
PMID: 23964690DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2010
First Posted
October 22, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
December 30, 2011
Record last verified: 2011-12