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OpenTrials
Completed

NCT Number: NCT00387725

Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

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

Completed

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Key information

Conditions

Healthy

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney Children's Hospital, Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rLP2086

Biological

Vaccine administered at 0, 1, and 6 months

Primary outcomes

  1. 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

  2. Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3

    Time frame: 1 month after Dose 3

  3. Percentage of Participants With at Least One Adverse Event (AE)

    Time frame: Dose 1 up to 1 month after Dose 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 13, 2006
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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