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

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ClinicalTrials.gov Identifier: NCT00604058
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Inactivated Poliomyelitis vaccine (IMOVAX) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : January 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A Biological: Inactivated Poliomyelitis vaccine (IMOVAX)
Fractional dose (1/5th) 0.1 mL, intradermally
Other Name: IMOVAX Polio (IPV) vaccine
Active Comparator: Group B Biological: Inactivated Poliomyelitis vaccine (IMOVAX)
A full dose, 0.5 mL, intramuscular
Other Name: IMOVAX Polio (IPV) vaccine


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 1 Month Post-vaccination ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 Month post-vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   42 Days to 50 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604058


Locations
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Philippines
Quezon city, Manila, Philippines
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00604058    
Other Study ID Numbers: IPV25
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Poliomyelitis
intradermal
Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
 Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs