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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Corynebacterium Infections Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pertussis Picornaviridae Infections Polio Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

15 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Norwegian Institute of Public Health

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Boostrix polio

Drug

1 dose (0.5 ml) i.m.

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Registry information

Official study title

Open Clinical Study to Assess the Immune Response and Safety of a Booster Dose (5th Dose) of a Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio Given to Healthy Adolescents 15-16 Years of Age.

Important dates

Study start: 2007
Study completion: 2007
First posted: Aug 9, 2007
Registry last updated: Aug 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed