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

NCT00514059 | Completed Phase 4

• 1 other identifier: SM07-01
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diphtheria; Tetanus; Pertussis; Polio

Keywords

Diphteria-tetanus-pertussis-polio vaccine; Booster immunization; Vaccine effect (Diphtheria-tetanus-acellular pertussis-polio); Immunity; Safety

Outcome Measures

Primary Outcomes (1)

• To measure vaccine specific antibody responses after a fifth dose of a combination vaccine against diphteria-tetanus-pertussis-polio. To register local and systemic reactions after vaccination.

Secondary Outcomes (1)

• To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.

Study Arms (1)

1

OTHER

Drug: Boostrix polio

Interventions

Boostrix polio DRUG

1 dose (0.5 ml) i.m.

1

Eligibility Criteria

• Age: 15 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead

Study Sites (1)

Norwegian Institute of Public Health

Oslo, Norway

Location

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Poliomyelitis

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Synne Sandbu, Physician

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: April 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 9, 2007

Record last verified: 2007-04

Locations

NO (1)