Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00932269
Status:
UNKNOWN
Last Update Posted:
2009-07-03
First Post:
2009-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System 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'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D010309', 'term': 'Parotitis'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-01', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-07-01', 'lastUpdatePostDateStruct': {'date': '2009-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishing the immunity situation among specific population groups, concerning diseases targeted by the NIP, by measuring antibody levels in serum using methods In-house ELISAs, Neutralization test (NT) and ELISAs from Dade Behring', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'To confirm the protection against polio among the Swedish population by measuring antibody levels in serum using NT against Polio virus types 1-3', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diphtheria', 'Tetanus', 'Pertussis', 'Polio', 'Haemophilus influenzae type B', 'Hib', 'Measles', 'Mumps', 'Rubella', 'Hepatitis B', 'Vaccine', 'Vaccination', 'Immunity', 'Vaccination program', 'Sweden', 'ELISA'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis', 'Polio', 'Haemophilus Influenzae Type B', 'Measles', 'Mumps', 'Rubella', 'Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '20955461', 'type': 'DERIVED', 'citation': 'Hallander HO, Lepp T, Ljungman M, Netterlid E, Andersson M. Do we need a booster of Hib vaccine after primary vaccination? A study on anti-Hib seroprevalence in Sweden 5 and 15 years after the introduction of universal Hib vaccination related to notifications of invasive disease. APMIS. 2010 Nov;118(11):878-87. doi: 10.1111/j.1600-0463.2010.02674.x. Epub 2010 Sep 2.'}]}, 'descriptionModule': {'briefSummary': "This is a randomized cross-sectional study of the Swedish population. Blood samples will be collected from a subpopulation in order to estimate the age specific sero-prevalence of the Swedish population for diseases included in the National Immunization Program (NIP), and to affirm the population's protection against polio. To be able to recommend complementary immunizations to immigrated children, a sub study focusing on foreign born teenagers will also be done and compared to children of the same age born in Sweden.", 'detailedDescription': 'Besides the main objectives stated in the summary, the study consists of:\n\nVaccine related objectives:\n\n* To estimate the seroprevalence regarding vaccine preventable diseases in the cohort of children about to enter adulthood (as a "receipt" of the vaccination program\'s functionality), and thereby form a basis for decision-making regarding recommendations about continuous vaccination in adult age\n* To evaluate the concentration of antibodies that full-term newborns receive from their mothers, and to estimate plausible consequences to optimize the schedule of the NIP for each vaccine preventable disease\n* To, in different age groups, evaluate changes over time and concentration of antibodies compared to a study conducted in 1997\n* To evaluate plausible changes in the seroprevalence, for instance among children, related to an increased use of combined vaccines\n* To document the age-specific seroprevalence against other diseases that will be vaccine preventable before start-up of new vaccination program\n* To estimate the population seroprevalence against certain diseases against which vaccines have been developed during recent years and that might be introduced into the vaccination program within a couple of decades\n\nMethod:\n\n* Adults: one blood sample of 10 mL blood from vein in arm from each individual\n* Children: one blood sample of 5-10 mL blood from vein or capillary in arm from each individual\n* Cord blood: one blood sample of 10 mL cord blood will be collected from each newborn in connection with childbirth\n\nThe objectives of the sub study are:\n\n* To conduct the same type of analysis on foreign born 14-16 year olds as on 14-16 year olds being born in Sweden\n* To also examine the immunity and infection situation with regard to Hepatitis B\n* To conduct the corresponding examinations and priorities among the 14-16 year olds born in Sweden serving as control group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Seroimmunity 2007: the Swedish population.\n\nSub study: foreign born children between 14-16 years of age.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed written consent (both groups)\n* immigrated to Sweden after 6 years of age from a country with polio vaccination coverage \\< 85 % (Sub study group)\n* living and attending school in Stockholm, Gothenburg or Malmoe (Sub study group)'}, 'identificationModule': {'nctId': 'NCT00932269', 'acronym': 'Sero 2007', 'briefTitle': 'Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease', 'organization': {'class': 'OTHER', 'fullName': 'Swedish Institute for Infectious Disease Control'}, 'officialTitle': 'Seroimmunity 2007. Serological Study of the Swedish Population Regarding Vaccine Preventable Diseases Within the National Immunization Program (NIP), and a Sub Study Focusing on Foreign Born 14-16 Year-Olds.', 'orgStudyIdInfo': {'id': '2007/132-31/4//2008/164-32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Seroimmunity 2007', 'description': 'Cord blood from 400 newborns, 1800 children (2 - 18 years) and 2400 adults (above 18 years), randomly selected and stratified in age groups, from which blood samples are taken.'}, {'label': 'Sub Study', 'description': '800 immigrated children (14 - 16 years) from which blood samples are taken.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '171 82', 'city': 'Solna', 'country': 'Sweden', 'facility': 'Swedish Institute for Infectious Disease Control', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}], 'overallOfficials': [{'name': 'Rigmor Thorstensson, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Swedish Institute for Infectious Disease Control'}, {'name': 'Eva Netterlid', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Institute for Infectious Disease Control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Institute for Infectious Disease Control', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Assoc. Prof. Rigmor Thorstensson', 'oldOrganization': 'Swedish Institute for Infectious Disease Control'}}}}