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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00604058
First received: January 17, 2008
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Poliomyelitis
Biological: Inactivated Poliomyelitis vaccine (IMOVAX)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 236
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   42 Days to 50 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604058

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

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00604058     History of Changes
Other Study ID Numbers: IPV25
Study First Received: January 17, 2008
Last Updated: January 20, 2014
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Sanofi:
Poliomyelitis
intradermal

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014