A Trial to Assess the Lot Consistency, Safety, Tolerability &

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

Meningococcal Vaccine Clinical Trial

Official title:
A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years

Status Completed

Clinical Trial Summary

This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Meningococcal Vaccine

Clinical Trial Details

NCT number	NCT01830855
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 3
Start date	April 2013
Completion date	April 2015

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	`NCT04440163` - MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age	Phase 3
Completed	`NCT04440176` - A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules	Phase 2
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	`NCT03135834` - 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.	Phase 3