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Completed

NCT Number: NCT00518492

Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent for this duration of immunity study to provide up to two additional blood samples. SBA & IgG testing will be done on these samples taken at 6 & 12 months. The sites participating in this duration of immunity study are the same sites participating in the 6108A1-500 study.

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Key information

Conditions

Healthy

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Herson, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Completed study 6108A1-500 (three doses administered and visit 9 completed).

Exclusion criteria

  • Bleeding diathesis or condition associated with prolonged bleeding time.
  • Any clinically significant chronic disease that, in the investigators judgment may be worsened by blood draw.

Treatment and study plan

blood sampling

Procedure

Blood draws at 6 and 12 months following end of 6108A1-500 trial.

Primary outcomes

  1. Immunogenicity at 6 and 12 months post 6108A1-500 study.

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 20, 2007
Registry last updated
Sep 16, 2009

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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