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:
Swedish Institute for Infectious Disease Control
Organization:
Study Overview
Official Title:
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.
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sero 2007
Brief Summary:
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.
Detailed Description:
Besides the main objectives stated in the summary, the study consists of:
Vaccine related objectives:
* 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
* 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
* To, in different age groups, evaluate changes over time and concentration of antibodies compared to a study conducted in 1997
* To evaluate plausible changes in the seroprevalence, for instance among children, related to an increased use of combined vaccines
* To document the age-specific seroprevalence against other diseases that will be vaccine preventable before start-up of new vaccination program
* 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
Method:
* Adults: one blood sample of 10 mL blood from vein in arm from each individual
* Children: one blood sample of 5-10 mL blood from vein or capillary in arm from each individual
* Cord blood: one blood sample of 10 mL cord blood will be collected from each newborn in connection with childbirth
The objectives of the sub study are:
* To conduct the same type of analysis on foreign born 14-16 year olds as on 14-16 year olds being born in Sweden
* To also examine the immunity and infection situation with regard to Hepatitis B
* To conduct the corresponding examinations and priorities among the 14-16 year olds born in Sweden serving as control group
Vaccine related objectives:
* 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
* 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
* To, in different age groups, evaluate changes over time and concentration of antibodies compared to a study conducted in 1997
* To evaluate plausible changes in the seroprevalence, for instance among children, related to an increased use of combined vaccines
* To document the age-specific seroprevalence against other diseases that will be vaccine preventable before start-up of new vaccination program
* 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
Method:
* Adults: one blood sample of 10 mL blood from vein in arm from each individual
* Children: one blood sample of 5-10 mL blood from vein or capillary in arm from each individual
* Cord blood: one blood sample of 10 mL cord blood will be collected from each newborn in connection with childbirth
The objectives of the sub study are:
* To conduct the same type of analysis on foreign born 14-16 year olds as on 14-16 year olds being born in Sweden
* To also examine the immunity and infection situation with regard to Hepatitis B
* To conduct the corresponding examinations and priorities among the 14-16 year olds born in Sweden serving as control group
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: