Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00885157
First received: April 20, 2009
Last updated: March 19, 2010
Last verified: March 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Poliomyelitis |
Biological: Inactivated types 1, 2, and 3 poliovirus, D antigens Biological: Inactivated types 1, 2, and 3 poliovirus, D antigens |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Polio and Post-Polio Syndrome
Drug Information available for:
Rabies Vaccine
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: No ]
- Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine [ Time Frame: 30 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
| Enrollment: | 225 |
| Study Start Date: | April 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 15 Months to 18 Months |
| Genders Eligible for Study: | Both |
| 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 More Information
Additional Information:
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Director, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00885157 History of Changes |
| Other Study ID Numbers: | IPV26 |
| Study First Received: | April 20, 2009 |
| Last Updated: | March 19, 2010 |
| Health Authority: | Philippines: Bureau of Food and Drugs |
Keywords provided by Sanofi:
|
Poliomyelitis intradermal |
Additional relevant MeSH terms:
|
Poliomyelitis Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013