Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine

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

• Registration Number: EUCTR2015-005188-17-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

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: 456

Inclusion Criteria

1) Aged =2 months and less than 3 months on the day of first study vaccine administration
2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
3) Informed consent form has been signed and dated by the parent or other legally acceptable representative
4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 456
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) Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
2) Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except Diphtheria, Tetanus, acellular Pertussis vaccine [DTaP], Haemophilus Influenzae Type b [Hib] vaccine, bacille Calmette-Guerin vaccine [BCG] and Hepatitis B given at least 7 days before and after study vaccination)Previous vaccination against poliomyelitis with either the trial vaccine or another vaccine
3) Receipt of immune globulins, blood or blood-derived products since birth
4) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
5) Congenital or acquired immunodeficiency in close contacts to the subjects
6) History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
7) At high risk for human immunodeficiency virus (HIV) infection during the trial
8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
9) Laboratory-confirmed or otherwise known thrombocytopenia, contraindicating intramuscular vaccination
10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
11) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
12) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
13) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature =37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
14) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
15) Any other contraindication as listed in the study vaccines' leaflets.

Study & Design

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