Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
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
1 other identifier
interventional
700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2009
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
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 14, 2010
CompletedFirst Posted
Study publicly available on registry
May 18, 2010
CompletedDecember 1, 2016
December 1, 2011
2 months
May 14, 2010
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-PRP antibody levels at day 31 post last vaccination
30 days after last vaccination
Secondary Outcomes (1)
Solicited local and systemic reactions, AEs, and SAEs
30 days post last vaccination
Study Arms (2)
Arm 1
ACTIVE COMPARATORArm 2
ACTIVE COMPARATORInterventions
a single dose was administered
a single dose was administered
Eligibility Criteria
You may qualify if:
- Infants 13-59 months of age.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Hebei Province, China
MeSH Terms
Conditions
Condition 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
May 14, 2010
First Posted
May 18, 2010
Study Start
August 1, 2009
Primary Completion
October 1, 2009
Study Completion
April 1, 2010
Last Updated
December 1, 2016
Record last verified: 2011-12