Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly

Sanofi

Status and phase

Completed

Phase 2

Conditions

Poliomyelitis

Treatments

Biological: Inactivated Poliomyelitis vaccine (IMOVAX)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604058

IPV25

Details and patient eligibility

About

The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.

Enrollment

236 patients

Sex

All

Ages

42 to 50 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria to be checked at the screening visit (SC):
Aged 0 to 7 days on the day of screening
Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
Informed consent form signed by the parent(s) or other legally acceptable representative
Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
Inclusion Criteria to be checked at the randomization visit (V01):
Aged 42 to 50 days on the day of inclusion
Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures

Exclusion criteria

Exclusion Criteria to be checked at the screening visit (SC):
Planned participation in another clinical trial during the present trial period
Illness that could interfere with trial conduct or completion, in the opinion of the investigator
Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
History of seizures
Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
Thrombocytopenia or bleeding disorder contraindicating IM injection
Exclusion Criteria to be checked at the randomization visit (V01):
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except BCG, DTP-Hib or Hepatitis B vaccines, which can not be given within 10 days before or after any study vaccination)
History of seizures
Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
Previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) injection
Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment