NCT00144313

Brief Summary

The purpose of this study is to determine immune status of adolescents who responded to a primary series of recombinant hepatitis B vaccine given at birth and to assess their response to a booster dose of vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

September 21, 2007

Status Verified

September 1, 2007

First QC Date

September 2, 2005

Last Update Submit

September 20, 2007

Conditions

Hepatitis

Keywords

vaccinehepatitis Bimmune memory

Outcome Measures

Primary Outcomes (1)

  • anti-HBs concentration

Secondary Outcomes (2)

  • side effects

  • anti-HBc and/or HBsAg following primary vaccine series in infancy

Interventions

hepatitis B vaccineBIOLOGICAL

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Eligible children are those who received the 2.5 µg/dose three-dose series of Recombivax HB® with the first dose having been given during the first week of life and the series completed by 9 months. All children were born to HBsAg
  • negative mothers, had no HBsAg-positive persons living in their households at the time of immunization, and had a minimum of one serologic specimen prior to the age of 18 months with results indicating an anti-HBs concentration of ≥10mIU/mL.

You may not qualify if:

  • Receipt of a fourth dose of any hepatitis B vaccine
  • History of allergic reaction after receiving hepatitis B vaccine or hypersensitivity to any components of the hepatitis B vaccine used for the booster dose
  • History of hepatitis B virus infection
  • Existence of disease known to affect the immune system (e.g., HIV, AIDS, SCID, chronic renal disease, cancer)
  • Current or recent (within 6 months) receipt of immunomodulatory therapy (e.g., systemic corticosteroids, chemotherapy) or blood products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CDC Arctic Investigations Program

Anchorage, Alaska, 99508, United States

Location

MeSH Terms

Conditions

HepatitisHepatitis B

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, Human

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Laura L Hammitt, MD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

August 1, 2005

Study Completion

January 1, 2006

Last Updated

September 21, 2007

Record last verified: 2007-09

Locations

US(1)