Trial Profile
A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS≥10 TO <26 YEARS OF AGE
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 15 Dec 2023
Price :
$35
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At a glance
- Drugs Meningococcal vaccine groups A B C Y W-135 conjugate (Primary) ; Meningococcal vaccine groups A C Y W-135 conjugate (Primary) ; PF 5212366 (Primary)
- Indications Meningococcal group A infections; Meningococcal group B infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections
- Focus Adverse reactions; First in man; Pharmacodynamics; Proof of concept; Registrational
- Sponsors Pfizer
- 01 Dec 2023 Results assessing Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults published in The Lancet Infectious Diseases
- 02 Feb 2023 This trial has been completed in Poland, according to European Clinical Trials Database record.
- 08 Nov 2022 Status changed from active, no longer recruiting to completed.