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

Meningitis, Meningococcal Clinical Trial

Official title:

A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808028
• Other study ID #: 6108A1-2001
• Secondary ID: B19710052008-007
• Status: Completed
• Phase: Phase 2
• First received: December 12, 2008
• Last updated: March 27, 2015
• Start date: February 2009
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis, Meningococcal

Intervention

Biological:
• meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
• meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
• meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

Other:
• normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Carlton	Victoria
Australia	Queensland Paediatric Infectious Diseases (QPID) Laboratory	Herston	Queensland
Australia	Department of Paediatrics, Women's & Children's Hospital	North Adelaide	South Australia
Australia	Children's Clinical Research Facility, Vaccine Trials Group (VTG),	Subiaco	Western Australia
Poland	ZOZ w Debicy, Poradnia Chorob Zakaznych	Debica
Poland	SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie	Krakow
Poland	Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,	Krakow
Poland	NZOZ Salmed	Leczna
Poland	Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi	Lodz
Poland	Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego	Lodz
Poland	SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14	Lubartow
Poland	Eskulap Sp. z o. o., ul. Weteranow 46	Lublin
Poland	SP ZOZ, Poradnia Dziecieca w Grucie	Melno
Poland	NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak	Oborniki Slaskie
Poland	Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A	Poznan
Poland	NZLA Michalkowice, Jarosz i Partnerzy	Siemianowice Slaskie
Poland	NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia	Torun
Poland	Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej	Trzebnica
Poland	Klinika Pediatrii i Chorob Infekcyjnych	Wroclaw
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1	Wroclaw
Spain	Clinica Virgen del Mar	Almeria
Spain	Hospital General de Cataluna	Barcelona
Spain	Hospital U. de Getafe	Getafe	Madrid
Spain	Hospital U. 12 de Octubre	Madrid
Spain	Hospital Clinico Universitario de Santiago de Compostela	Santiago de Compostela	La Coruna
Spain	Centro de Salud Nazaret	Valencia
Spain	Complexo Hospitalario Xeral-Cies de Vigo	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B		Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3	No
Primary	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	No
Primary	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	No
Primary	Percentage of Participants With Atleast One Adverse Event (AE): Stage 1		Vaccination 1 upto 1 Month after vaccination 3	Yes
Primary	Percentage of Participants With Atleast One Adverse Event (AE): Stage 2		6 month after vaccination 3 up to 48 months	Yes
Secondary	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	No

External Links

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