Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly
January 20, 2014 updated by: Sanofi Pasteur, a Sanofi Company
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
225
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manila
-
Quezon city, Manila, Philippines
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Will receive fractional doses of IPV Intradermally
|
0.1 mL, intradermal
Other Names:
0.5 mL, Intramuscular
Other Names:
|
|
Active Comparator: Group B
Will receive full doses of IPV Intramuscularly
|
0.1 mL, intradermal
Other Names:
0.5 mL, Intramuscular
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination.
Time Frame: 30 days post-vaccination
|
30 days post-vaccination
|
|
Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine
Time Frame: 30 days post-vaccination and entire study duration
|
30 days post-vaccination and entire study duration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
April 20, 2009
First Submitted That Met QC Criteria
April 20, 2009
First Posted (Estimate)
April 21, 2009
Study Record Updates
Last Update Posted (Estimate)
January 22, 2014
Last Update Submitted That Met QC Criteria
January 20, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPV26
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