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OpenTrials
Completed

NCT Number: NCT00211991

Evaluation of Consistency of StaphVAX Manufacturing Lots

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.

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Key information

Conditions

Staphylococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanderbuilt University

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy,
  • written informed consent,
  • negative serum pregnancy test if appropriate,
  • expect to comply with protocol procedures and schedule

Exclusion criteria

  • known HIV,
  • immunomodulatory drugs,
  • malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
  • active infection in the 2 weeks prior to study injection,
  • serious S. aureus infection within the last 3 months prior to injection,
  • use of investigational drugs, vaccines or devices within the prior 30 days,
  • hypersensitivity to components of StaphVAX

Treatment and study plan

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Biological

Primary outcomes

  1. Type-specific antibody concentrations 6 weeks after vaccine dose.

Secondary outcomes

  1. Antibody concentrations at other time points.

  2. Elicited health events.

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Collaborators

  • Vanderbilt University

Registry information

Official study title

A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
May 14, 2012

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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