đź“Š Evidence-Based Reference
haemophilus influenzae type b antiserum
Hyland Therapeutic Div., Travenol Laboratories
Summary: The haemophilus influenzae type b antiserum is used for immunization against Hib infections. Key evidence highlights its role in reducing Hib disease incidence post-vaccination.
FDA Clearance Information
Pathway
510K
Number
K820192 ↗
Decision Date
March 11, 1982
Product Code
GRP
Device Class
Class 2
Evidence
419 studies
The haemophilus influenzae type b antiserum was cleared by the FDA via the 510k pathway on March 11, 1982. It is manufactured by Hyland Therapeutic Div., Travenol Laboratories and classified as a Class 2 device.
What It Is
The haemophilus influenzae type b antiserum is an immunological agent designed to provide passive immunity against infections caused by Haemophilus influenzae type b. It is primarily used in clinical settings to prevent invasive Hib diseases.
Clinical Applications
This antiserum is commonly used in pediatric populations to prevent Hib infections, particularly in regions with high incidence rates. It is also utilized in outbreak settings to provide immediate immunity.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and observational studies, conducted between 1993 and 2021. These studies explore the efficacy and safety of Hib vaccination.
Reported Outcomes
Published studies report significant reductions in Hib disease incidence following vaccination. For instance, routine immunization in The Gambia led to the elimination of Hib disease. In France, high vaccination coverage correlated with decreased Hib carriage.
Safety Profile
Reported complications include mild adverse reactions typical of immunizations, such as local site reactions and fever. No severe adverse events were consistently reported across the studies.
Evidence Limitations
Evidence gaps include limited data on long-term immunity and the impact of different vaccination schedules. Further research is needed to explore Hib carriage dynamics in diverse populations.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for haemophilus influenzae type b antiserum?
The antiserum is indicated for the prevention of invasive diseases caused by Haemophilus influenzae type b, particularly in children and during outbreaks.
What outcomes have been reported in clinical studies?
Studies have reported a significant reduction in Hib disease incidence and carriage following vaccination.
What complications have been reported?
Safety data indicate mild adverse reactions such as local site reactions and fever, with no severe adverse events consistently reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.