---
title: Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine
nct_id: NCT00514059
overall_status: COMPLETED
phase: PHASE4
sponsor: Norwegian Institute of Public Health
study_type: INTERVENTIONAL
primary_condition: Diphtheria
countries: Norway
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00514059.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00514059"
ct_last_update_post_date: 2007-08-09
last_seen_at: "2026-05-12T06:12:08.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine

**Official 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.

**NCT ID:** [NCT00514059](https://clinicaltrials.gov/study/NCT00514059)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 83
- **Lead Sponsor:** Norwegian Institute of Public Health
- **Conditions:** Diphtheria, Tetanus, Pertussis, Polio
- **Start Date:** 2007-04
- **Completion Date:** 2007-06
- **CT.gov Last Update:** 2007-08-09

## 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.

## Eligibility

- **Minimum age:** 15 Years
- **Maximum age:** 16 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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)
```

## Arms

- **1** (OTHER)

## Interventions

- **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.**

## Locations (1)

- Norwegian Institute of Public Health, Oslo, Norway

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.norwegian institute of public health|oslo||norway` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00514059.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00514059*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*