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Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00387725
First received: October 11, 2006
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents


Condition Intervention Phase
Healthy
Biological: rLP2086
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Observer-blinded, Parallel-group, Active-control, Phase ½ Trial Of The Safety, Immunogenicity, And Tolerability Of 20 Mg, 60 Mg, And 200 Mg Of Meningococcal Group B Rlp2086 Vaccine In Healthy Children And Adolescents Aged 8 To 14 Years

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 [ Time Frame: 1 month after Dose 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 [ Time Frame: 1 month after Dose 3 ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Dose 1 up to 1 month after Dose 3 ] [ Designated as safety issue: Yes ]

Enrollment: 127
Study Start Date: November 2006
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
20ug Experimental
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months
Experimental: Group 2
60ug Experimental
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months
Experimental: Group 3
200ug Experimental
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months
Active Comparator: Group 4
Active comparator
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria

  • Aged 8 to 14 years at the time of enrollment.
  • Healthy male or female subjects
  • Negative urine pregnancy test for female subjects

Exclusion Criteria:

Exclusion Criteria

  • Prior vaccination with a meningococcal B vaccine
  • Prior meningococcal disease
  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: NCT00387725

Locations
Australia, New South Wales
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Children's Hospital
Herston, Queensland, Australia, 4006
Australia, Western Australia
Princess Margaret Hospital for Children
Subiaco, Western Australia, Australia, 6008
Australia
Sir Albert Sakzewski Virus Research Centre (SASVRC)
Herston, Australia, QLD 4006
Women's & Children's Hospital
North Adelaide, Australia, SA 5006
The Telethon Institute for Child Health Research
Subiaco, Australia, WA 6008
National Centre for Immunisation
Westmead, Australia, NSW 2145
Department of Paediatrics and Child Health
Woden, Australia, ACT 2606
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00387725     History of Changes
Other Study ID Numbers: 6108A1-501, B1971006
Study First Received: October 11, 2006
Results First Received: November 14, 2014
Last Updated: November 14, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Pfizer:
Adolescent
Meningococcal
Safety

ClinicalTrials.gov processed this record on November 25, 2014