Ribitol Clinical Trials

Size	Price	Qty
250mg	USD 79

Clinical Trials

Multiple Phase 3 and Phase 4 clinical trials sponsored by GlaxoSmithKline evaluate pediatric formulations of this biological component, focusing on multi-valent combination vaccines for diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, poliomyelitis, and hepatitis B. Ranging in recruitment status from withdrawn to completed, these protocols assess the safety and immunogenicity of conjugate vaccine regimens designed to prevent complex bacterial and viral infections in children.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03128489	Withdrawn	Diphtheria\|Acellular Pertussis\|Haemophilus Influenzae Type b\|Tetanus\|Poliomyelitis	GlaxoSmithKline	2017-12-01	Phase 3
NCT02853929	Completed	Diphtheria\|Hepatitis B\|Acellular Pertussis\|Haemophilus Influenzae Type b\|Tetanus\|Poliomyelitis\|Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines	GlaxoSmithKline	2016-09-19	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Ribitol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ribitol serves as a metabolic intermediate and essential structural component that incorporates into teichoic acids within bacterial cell walls and contributes to riboflavin synthesis. By maintaining microbial cell envelope integrity and biochemical stability, ribitol derivative structures are relevant to the immunogenicity and formulation of combination conjugate vaccines targeting infectious diseases such as diphtheria, tetanus, and Haemophilus influenzae type b.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).