Trial record 1 of 1 for:
IPV25
Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly
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| ClinicalTrials.gov Identifier: NCT00604058 |
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Recruitment Status :
Completed
First Posted : January 29, 2008
Last Update Posted : January 22, 2014
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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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 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 |
Resource links provided by the National Library of Medicine
| 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 |
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 ]
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 ]
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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
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): NCT00604058
Locations
| Philippines | |
| Quezon city, Manila, Philippines | |
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ):
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Poliomyelitis intradermal |
Additional relevant MeSH terms:
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Poliomyelitis Myelitis Central Nervous System Infections Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases |
Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |