Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine

N

Norwegian Institute of Public Health

Status and phase

Completed
Phase 4

Conditions

Diphtheria
Polio
Pertussis
Tetanus

Treatments

Drug: Boostrix polio

Study type

Interventional

Funder types

Other

Identifiers

NCT00514059
SM07-01

Details and patient eligibility

About

An open clinical trial to study the immune response and safety after giving a booster dose (5th Dose) of a combination vaccine against Diphteria-Tetanus-Pertussis-Polio to healthy adolescents 15-16 Years of age. The first three doses were given during the first year of life, according to the Norwegian child immunization program. The fourth dose was given in a previous clinical trial performed in 1998 when the children were 6-7 years old. In 2006 there was a change in the child immunization program in Norway: a fourth dose of a Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio is given to children 6-7 years old. This study will give us information if there is need for an additional dose (5th dose) of a combination vaccine, containing the pertussis components, before the adolescents are leaving secondary school.

Enrollment

83 patients

Sex

All

Ages

15 to 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy adolescents who have previously received a dose of a vaccine against diphteria, tetanus, pertussis and polio in a clinical trial in 1998
  • Written informed consent from the adolescent and one of his/her parents
  • The family must understand norwegian

Exclusion criteria

  • Serious chronic diseases
  • Vaccination against tetanus last 12 months
  • Immunization with a Diphteria vaccine component after the study in 1998
  • Suspected or confirmed immune deficiency
  • Immunological/immunosuppressive treatment
  • Pregnancy
  • Serious reactions to previous immunization with any of the vaccine components
  • Acute fever (axillary temperature ≥ 38°C) at the the of vaccination. (Postpone vaccination)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

83 participants in 1 patient group

1
Other group
Treatment:
Drug: Boostrix polio

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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