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Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly

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ClinicalTrials.gov Identifier: NCT00885157
Recruitment Status : Completed
First Posted : April 21, 2009
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 purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety.

Objectives:

  • To describe in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25 study.
  • To describe in each group the safety of the booster dose of IMOVAX Polio vaccine administered intradermally or intramuscularly.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Inactivated types 1, 2, and 3 poliovirus, D antigens Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Fractional Booster Dose of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intradermally Versus Full Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intramuscularly at 15 to 18 Months of Age in Healthy Toddlers in The Philippines
Study Start Date : April 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Imovax

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Will receive fractional doses of IPV Intradermally
 Biological: Inactivated types 1, 2, and 3 poliovirus, D antigens
0.1 mL, intradermal
Other Name: Imovax Polio
Active Comparator: Group B
Will receive full doses of IPV Intramuscularly
 Biological: Inactivated types 1, 2, and 3 poliovirus, D antigens
0.5 mL, Intramuscular
Other Name: Imovax Polio


Outcome Measures
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Primary Outcome Measures :
  1. Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. [ Time Frame: 30 days post-vaccination ]
  2. Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine [ Time Frame: 30 days post-vaccination and entire study duration ]

Eligibility Criteria
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Ages Eligible for Study:   15 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 15 to 18 months on the day of inclusion
  • 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
  • Child having completed all visits of the IPV25 study (NCT00604058), including the three-dose primary vaccination series with the study vaccine (IMOVAX Polio), using the route of administration as designated by randomization.

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or 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 of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine during the present trial period
  • Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
  • History of seizures
  • History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
  • Previous fourth dose 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 IM injection
  • Febrile illness (temperature ≥38.0 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885157


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: NCT00885157    
Other Study ID Numbers: IPV26
First Posted: April 21, 2009    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