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Not listed Phase 4 Interventional

Adolescents' Response to Hepatitis B Vaccine Booster Dose

ClinicalTrials.gov ID: NCT01341275

Public ClinicalTrials.gov record NCT01341275. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 1:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The aims of this study are to determine: 1. the degree of immunity against hepatitis B, 2. factors associated with immunity against hepatitis B, 3. if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and 4. if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents. Study subjects eligible for enrollment will: * have blood drawn for baseline serologies * receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug dose) * have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine) The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.

Study identification

NCT ID
NCT01341275
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Baylor College of Medicine
Other
Enrollment
400 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
16 Years to 19 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2010
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011
Last update posted
Apr 24, 2011

2010 – 2011

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Texas Children's Hospital Houston Texas 77030 Recruiting
Texas Children's Pediatric Associates Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01341275, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 24, 2011 · Synced Sep 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01341275 live on ClinicalTrials.gov.

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