Drugs / Hexavalent vaccine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed Other Shan 6 — —

“The pediatric hexavalent vaccine, Shan 6, was submitted in India in June.” sanofi.com ↗

Trials 3

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 32 trials · 1 met primary
Phase 3 NCT03402776 May 2018 → May 2020 disease related to hematopoietic stem cell transplant University Hospital, Grenoble Unknown No outcome recorded
Phase 3 NCT01839175 Apr 2013 → Jul 2014 meningococcal infection, viral infectious disease Sanofi Pasteur, a Sanofi Company Completed Met primary
Phase 41 trial
Phase 4 NCT06748612 Jan 2025 → Dec 2027 expected poliomyelitis International Centre for Diarrhoeal Disease Research, Bangladesh Not yet recruiting No outcome recorded
Comparator or background therapy1 trial
Phase 2 NCT06879327 Background May 2025 → Oct 2027 expected Plasmodium falciparum malaria PATH Active not recruiting No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Hexavalent Vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT06879327 ↗
3

NCT03402776 ↗

NCT01839175 ↗

NCT06748612 ↗

Known as wP-Hexa “Whole-cell pertussis hexavalent vaccine (wP-Hexa): Each 0.5 ml dose contains diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen, Haemophilus...” NCT06748612 ↗
Modality Vaccine “DTaP-IPV-HB-PRP-T is a hexavalent vaccine” PMID 30471953 ↗ Nov 2018
Route Intramuscular “0.5 mL intramuscular injection at 2, 3 and 4 months of age” NCT01839175 ↗