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

Study Overview
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Brief Summary
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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.

Official Title
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Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine Administered Intradermally vs Full Doses of Inactivated Poliomyelitis Vaccine Administered Intramuscularly in Healthy Philippines Infants

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: Inactivated Poliomyelitis vaccine (IMOVAX)
* Biological: Inactivated Poliomyelitis vaccine (IMOVAX)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 50 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: Inactivated Poliomyelitis vaccine (IMOVAX)<br>* Fractional dose (1/5th) 0.1 mL, intradermally<br>* Other names: IMOVAX Polio (IPV) vaccine;|
| Active Comparator: Group B<br> | Biological: Inactivated Poliomyelitis vaccine (IMOVAX)<br>* A full dose, 0.5 mL, intramuscular<br>* Other names: IMOVAX Polio (IPV) vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 Month Post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity: To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination Safety: To describe in each group the safety after each dose of the study vaccines |  | 1 Month post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poliomyelitis, intradermal