A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.

Meningococcal Vaccine Clinical Trial

Official title:
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

Clinical Trial Summary

This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Meningococcal Vaccine

Clinical Trial Details

NCT number	NCT03135834
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 3
Start date	April 24, 2017
Completion date	October 25, 2022

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04645966` - A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants	Phase 2
Completed	`NCT01299480` - A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years	Phase 2
Completed	`NCT01323270` - A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.	Phase 2
Completed	`NCT04440176` - A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules	Phase 2
Completed	`NCT04440163` - MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age	Phase 3
Completed	`NCT03509051` - Prospective Study on the Vaccine Response to Meningococcal B Vaccine After Allogeneic Stem Cell Transplantation	N/A
Completed	`NCT02975596` - MenB Vaccine: Implementation Via Information, Empowerment and Accessibility	N/A
Completed	`NCT03263403` - Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.	Phase 2/Phase 3
Completed	`NCT04893811` - Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age	Phase 4
Completed	`NCT04819113` - Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age	Phase 3
Completed	`NCT01830855` - A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years	Phase 3