Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00604058
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2008-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011054', 'term': 'Poliovirus Vaccine, Inactivated'}, {'id': 'D011819', 'term': 'Rabies Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D015164', 'term': 'Vaccines, Inactivated'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D023321', 'term': 'Poliovirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-20', 'studyFirstSubmitDate': '2008-01-17', 'studyFirstSubmitQcDate': '2008-01-28', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '1 Month Post-vaccination'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '1 Month post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Poliomyelitis', 'intradermal'], 'conditions': ['Poliomyelitis']}, 'referencesModule': {'references': [{'pmid': '22153001', 'type': 'DERIVED', 'citation': 'Cadorna-Carlos J, Vidor E, Bonnet MC. Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines. Int J Infect Dis. 2012 Feb;16(2):e110-6. doi: 10.1016/j.ijid.2011.10.002. Epub 2011 Dec 5.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '50 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria to be checked at the screening visit (SC):\n* Aged 0 to 7 days on the day of screening\n* Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg\n* Informed consent form signed by the parent(s) or other legally acceptable representative\n* Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures\n* Inclusion Criteria to be checked at the randomization visit (V01):\n* Aged 42 to 50 days on the day of inclusion\n* Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures\n\nExclusion Criteria:\n\n* Exclusion Criteria to be checked at the screening visit (SC):\n* Planned participation in another clinical trial during the present trial period\n* Illness that could interfere with trial conduct or completion, in the opinion of the investigator\n* Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response\n* History of seizures\n* Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity\n* Thrombocytopenia or bleeding disorder contraindicating IM injection\n* Exclusion Criteria to be checked at the randomization visit (V01):\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy\n* 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\n* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator\n* Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response\n* 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)\n* History of seizures\n* Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity\n* History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)\n* Previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine\n* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) injection\n* Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment'}, 'identificationModule': {'nctId': 'NCT00604058', 'briefTitle': 'Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'IPV25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Biological: Inactivated Poliomyelitis vaccine (IMOVAX)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'interventionNames': ['Biological: Inactivated Poliomyelitis vaccine (IMOVAX)']}], 'interventions': [{'name': 'Inactivated Poliomyelitis vaccine (IMOVAX)', 'type': 'BIOLOGICAL', 'otherNames': ['IMOVAX Polio (IPV) vaccine'], 'description': 'Fractional dose (1/5th) 0.1 mL, intradermally', 'armGroupLabels': ['Group A']}, {'name': 'Inactivated Poliomyelitis vaccine (IMOVAX)', 'type': 'BIOLOGICAL', 'otherNames': ['IMOVAX Polio (IPV) vaccine'], 'description': 'A full dose, 0.5 mL, intramuscular', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quezon City', 'state': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}