Pneumococci and Hib Vaccination After Neurotrauma or Neurosurgery
1 other identifier
interventional
85
0 countries
N/A
Brief Summary
The purpose of this study is to determine wether skull trauma or neurosurgery affect the immune response to two vaccine types.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2001
Longer than P75 for phase_2
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
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 30, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedJune 21, 2016
June 1, 2016
7 years
May 30, 2016
June 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change from baseline of IgG anti-Hib (ug/ml)
baseline and 3 weeks
Change from baseline of IgG anti-Hib (ug/ml)
baseline and 6 weeks
Change from baseline of specific IgG against pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (ug/ml)
baseline and 3 weeks
Change from baseline of specific IgG against pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (ug/ml)
baseline and 6 weeks
Study Arms (3)
Neurotrauma
ACTIVE COMPARATORPatients with basilar skull fracture with or without known cerebrospinal fluid leakage were enrolled in the neurotrauma (NT) group. All patients were vaccinated with two vaccines at the same time, 0,5 ml PPSV23 and 0,5 ml Act-HIB which is a conjugate vaccine against H. influenzae type b.The vaccines were administered by subcutaneous injections within 10 days from trauma.
Neurosurgery
ACTIVE COMPARATORPatients scheduled for elective, transsphenoidal pituitary gland surgery were assigned to the neurosurgery (NS) group. All patients were vaccinated with two vaccines at the same time, 0,5 ml PPSV23 and 0,5 ml Act-HIB which is a conjugate vaccine against H. influenzae type b.The vaccines were administered by subcutaneous injections within 10 days from surgery.
Control
ACTIVE COMPARATORAll control patients had undergone neurotrauma with or without basilar skull fracture, or had neurosurgery, at least three weeks earlier. All patients were vaccinated with two vaccines at the same time, 0,5 ml PPSV23 and 0,5 ml Act-HIB which is a conjugate vaccine against H. influenzae type b. They were vaccinated at least three weeks after trauma or surgery. The vaccines were administered by subcutaneous injections.
Interventions
described in "Arm description"
Eligibility Criteria
You may qualify if:
- Basilar skull fracture or transsphenoidal pituitary gland surgery
- Own or presumed consent (by next of kin of unconscious)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hedberg AL, Pauksens K, Enblad P, Soderberg J, Johansson B, Kayhty H, Sjolin J. Pneumococcal polysaccharide vaccination administered early after neurotrauma or neurosurgery. Vaccine. 2017 Feb 7;35(6):909-915. doi: 10.1016/j.vaccine.2016.12.065. Epub 2017 Jan 6.
PMID: 28069358DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Sjölin, Professor
Uppsala University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2016
First Posted
June 20, 2016
Study Start
January 1, 2001
Primary Completion
January 1, 2008
Study Completion
January 1, 2010
Last Updated
June 21, 2016
Record last verified: 2016-06