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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00808028
First received: December 12, 2008
Last updated: March 27, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Meningitis, Meningococcal
Biological: meningococcal B rLP2086 vaccine.
Other: normal saline (placebo)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 [ Time Frame: Before vaccination 1 up to 1 month after vaccination 2 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Before vaccination 1 up to 1 month after vaccination 3 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 [ Time Frame: Vaccination 1 upto 1 Month after vaccination 3 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 [ Time Frame: 6 month after vaccination 3 up to 48 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level [ Time Frame: 1 month before vaccination 1, 1 month after vaccination 2, 3 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B [ Time Frame: Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3 ] [ Designated as safety issue: No ]

Enrollment: 538
Study Start Date: February 2009
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dose level 1 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Experimental: 2
dose level 2 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Experimental: 3
dose level 3 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Placebo Comparator: 4
normal saline (placebo)
Other: normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808028

Locations
Australia, Queensland
Queensland Paediatric Infectious Diseases (QPID) Laboratory
Herston, Queensland, Australia, 4029
Australia, South Australia
Department of Paediatrics, Women's & Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Carlton, Victoria, Australia, 3053
Australia, Western Australia
Children's Clinical Research Facility, Vaccine Trials Group (VTG),
Subiaco, Western Australia, Australia, 6008
Poland
ZOZ w Debicy, Poradnia Chorob Zakaznych
Debica, Poland, 39-200
SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
Krakow, Poland, 31-202
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
Krakow, Poland, 31-503
NZOZ Salmed
Leczna, Poland, 21-010
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
Lodz, Poland, 91-347
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
Lodz, Poland, 91-347
SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14
Lubartow, Poland, 21-100
Eskulap Sp. z o. o., ul. Weteranow 46
Lublin, Poland, 20-044
SP ZOZ, Poradnia Dziecieca w Grucie
Melno, Poland, 86-330
NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak
Oborniki Slaskie, Poland, 55-120
Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A
Poznan, Poland, 61-734
NZLA Michalkowice, Jarosz i Partnerzy
Siemianowice Slaskie, Poland, 41-03
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia
Torun, Poland, 87-100
Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej
Trzebnica, Poland, 55-100
Klinika Pediatrii i Chorob Infekcyjnych
Wroclaw, Poland, 50-345
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wroclaw, Poland, 50-345
Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruna, Spain, 15706
Hospital U. de Getafe
Getafe, Madrid, Spain, 28905
Complexo Hospitalario Xeral-Cies de Vigo
Vigo, Pontevedra, Spain, 36204
Clinica Virgen del Mar
Almeria, Spain, 04120
Hospital General de Cataluna
Barcelona, Spain, 08195
Hospital U. 12 de Octubre
Madrid, Spain, 28041
Centro de Salud Nazaret
Valencia, Spain, 46024
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00808028     History of Changes
Other Study ID Numbers: 6108A1-2001, B1971005, 2008-007789-51
Study First Received: December 12, 2008
Results First Received: March 27, 2015
Last Updated: March 27, 2015
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2015