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Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections

L

Laval University

Status and phase

Completed
Phase 4

Conditions

Vaccination
Hepatitis B

Treatments

Biological: Engerix-B

Study type

Interventional

Funder types

Other

Identifiers

NCT00169858
103860/257 ext. 278
HBV-257 ext. HBV-278

Details and patient eligibility

About

Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs between age 15 and 35; the proportion of vaccinated children who will still be protected at this age is currently unknown. This study is designed to determine:

  • persistence of immunity until age 25
  • persistence of immunological memory as demonstrated by an anamnestic response following a booster dose
  • the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the primary vaccination course (at age (15, 20 or 25).

Full description

Three doses of Engerix-B vaccine (10 mkg) were administered according to 0, 1, 6 month schedule to 1126 9-10 year-old children.

The primary objective of the study is to evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.

Secondary objectives

  • To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert
  • To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)
  • To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)
  • To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)
  • To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)
  • To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects (Group C)
  • To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster
  • To evaluate safety

Enrollment

1,129 patients

Sex

All

Ages

8 to 10 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Previously completed the 1995 to 1996 Hepatitis B vaccination program vaccinations (Primary study) to the best of his/her knowledge and already enrolled and followed in the long term study
  • Must be HBc negative
  • Required standard interval between last dose of primary immunization and booster vaccination
  • Written informed consent obtained from the subject
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study
  • Previously completed routine childhood vaccination to the best of his/her knowledge
  • If the subject is female, and the potential of pregnancy exists, it must be asked prior to immunization by the study nurse. According to the protocol d'immunisation du Québec, Engerix-B is not contra-indicated during pregnancy. However, if a participant thinks she could be pregnant (sexually active and no oral contraception or intra uterine device), a pregnancy test will be carried out. In case of pregnancy, the booster vaccination will be performed after delivery.

Exclusion criteria

  • Not applicable

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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