Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

• Conditions: PertussisTetanusDiphtheriaPoliomyelitisHepatitis B; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005196-24-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1) Age 11 years and < 14 years of age.
2) Signed, witnessed and dated informed consent that is obtained prior to the first study intervention.
3) Judged to be in good health on the basis of reported medical history.
4) Plans to remain in the study area for the length of the trial.
5) All minors have a parent or legal guardian who can read, write and understand English or French.
6) Pregnancy test to be performed on all female participants at the time of enrollment into the study (prior to day of first immunization visit).
Are the trial subjects under 18? yes
Number of subjects for this age range: 174
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Pregnancy.
2) Known or suspected primary disease of the immune system [conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5].
3) Malignancy or is receiving immunosuppressive therapy (e.g., daily systemic prednisone = 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as could participants on a short course of oral steroids, 5-7 days, as long as there are not two courses within the previous two week period).
4) Prior receipt of any pertussis, diphtheria, tetanus or polio containing vaccines, including Hepatitis B vaccine, within the past 5 years.
5) Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction.
6) Known impairment of neurologic function or seizure disorder of any etiology.
7) Personal history of physician diagnosed or laboratory confirmed pertussis disease within the last 2 years.
8) Receipt of blood products or immunoglobulin within the previous 3 months.
9) Known or suspected allergy to any of the vaccines intended for use in the study or any of the vaccine components including neomycin, streptomycin and polymyxin B.
10) Receipt of any vaccine within 2 weeks of receiving a study vaccine.
11) Daily use of non-steroidal anti-inflammatory drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified