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COMPLETEDPHASE3

A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

An Open-label, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With Either HEXAVAC® or INFANRIX®-HEXA

NCT00693186•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

Primary objective: * To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg . Secondary objectives: * Additional immunogenicity assessments * Standard safety assessment.

Eligibility

Age

4 - 7 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy child of 4 to 7 years of age of either gender,
•Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life,
•Informed consent form signed by the parent(s) or by the legal representative.
•Parent(s) or legal representative able to understand and comply with the study procedures.

Exclusion Criteria

•Any recent (\<=3 days) history of febrile illness prior to vaccination,
•Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination,
•History of clinical or serological-confirmed diagnosis of infection due to hepatitis B,
•History or current close contact with known carriers of hepatitis B virus,
•Prior known sensitivity/allergy to any component of the study vaccines,
•Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
•Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
•Any immune impairment or humoral/cellular deficiency or depressed immunity,
•Any recent (\<=30 days) long-term (\>=14 days) administration of systemic corticosteroids given daily or on alternate days at \>=20 mg/day prednisone equivalent or scheduled administration through Visit 2,
•Any receipt (\<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through Visit 2,
+2 more criteria

Locations (5)

Unità Operativa Semplice di Epidemiologia (UOSE)

Quarto, Napoli, Italy

Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"

Latisana, Udine, Italy

Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)

Modica, Italy

AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c

Ragusa, Italy

Dipartimento di Prevenzione Servizio di Igiene Pubblica

Sassari, Italy

Key Dates

Start Date

October 1, 2008

Primary Completion Date

December 1, 2009

Completion Date

March 1, 2010

Last Updated

September 11, 2017

Enrollment

410

ACTUAL participants

Conditions

Hepatitis B

Interventions

HBVaxPRO® 5 µg / 0.5 mL

BIOLOGICAL

Engerix B® 10 µg / 0.5 mL

BIOLOGICAL

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

View study

RECRUITINGPHASE1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series