A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

Phase 2

Completed

• Conditions: Meningitis, Meningococcal
• Interventions: Other: normal saline (placebo); Biological: meningococcal B rLP2086 vaccine.

• Registration Number: NCT00808028
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Study Start: 2009-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Results First Submitted: 2015-03-27
• Results First Submitted QC: 2015-03-27
• Last Update Submitted: 2015-03-27
• Results First Posted: 2015-04-14
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 538

Inclusion Criteria

• Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
• Negative urine pregnancy test for all female subjects.
• Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria

• History of any invasive meningococcal disease.
• A previous anaphylactic or severe vaccine-associated adverse reaction.
• Any clinically significant chronic disease.
• A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
• Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	normal saline (placebo)	normal saline (placebo)
2	meningococcal B rLP2086 vaccine.	dose level 2 rLP2086 vaccine
1	meningococcal B rLP2086 vaccine.	dose level 1 rLP2086 vaccine
3	meningococcal B rLP2086 vaccine.	dose level 3 rLP2086 vaccine

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2	Before vaccination 1 up to 1 month after vaccination 2
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3	Before vaccination 1 up to 1 month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1	Vaccination 1 upto 1 Month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2	6 month after vaccination 3 up to 48 months

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level	1 month before vaccination 1, 1 month after vaccination 2, 3

Trial Locations

Locations (27)

ZOZ w Debicy, Poradnia Chorob Zakaznych; 🇵🇱 Debica, Poland

SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie; 🇵🇱 Krakow, Poland

NZOZ Salmed; 🇵🇱 Leczna, Poland

Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A; 🇵🇱 Poznan, Poland

Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej; 🇵🇱 Trzebnica, Poland

Klinika Pediatrii i Chorob Infekcyjnych; 🇵🇱 Wroclaw, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1; 🇵🇱 Wroclaw, Poland

Complexo Hospitalario Xeral-Cies de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Children's Clinical Research Facility, Vaccine Trials Group (VTG),; 🇦🇺 Subiaco, Western Australia, Australia

Department of Paediatrics, Women's & Children's Hospital; 🇦🇺 North Adelaide, South Australia, Australia

SP ZOZ, Poradnia Dziecieca w Grucie; 🇵🇱 Melno, Poland

Hospital U. de Getafe; 🇪🇸 Getafe, Madrid, Spain

SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14; 🇵🇱 Lubartow, Poland

Hospital U. 12 de Octubre; 🇪🇸 Madrid, Spain

Centro de Salud Nazaret; 🇪🇸 Valencia, Spain

Queensland Paediatric Infectious Diseases (QPID) Laboratory; 🇦🇺 Herston, Queensland, Australia

Royal Children's Hospital; 🇦🇺 Carlton, Victoria, Australia

Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi; 🇵🇱 Lodz, Poland

Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego; 🇵🇱 Lodz, Poland

NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak; 🇵🇱 Oborniki Slaskie, Poland

NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia; 🇵🇱 Torun, Poland

Clinica Virgen del Mar; 🇪🇸 Almeria, Spain

Hospital General de Cataluna; 🇪🇸 Barcelona, Spain

Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,; 🇵🇱 Krakow, Poland

Eskulap Sp. z o. o., ul. Weteranow 46; 🇵🇱 Lublin, Poland

NZLA Michalkowice, Jarosz i Partnerzy; 🇵🇱 Siemianowice Slaskie, Poland

Hospital Clinico Universitario de Santiago de Compostela; 🇪🇸 Santiago de Compostela, La Coruna, Spain