Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease (Sero 2007)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Swedish Institute for Infectious Disease Control.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Swedish Institute for Infectious Disease Control
ClinicalTrials.gov Identifier:
NCT00932269
First received: June 30, 2009
Last updated: July 1, 2009
Last verified: July 2009
  Purpose

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.


Condition Phase
Diphtheria
Tetanus
Pertussis
Polio
Haemophilus Influenzae Type B
Measles
Mumps
Rubella
Hepatitis B
Phase 0

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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.

Resource links provided by NLM:


Further study details as provided by Swedish Institute for Infectious Disease Control:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To confirm the protection against polio among the Swedish population by measuring antibody levels in serum using NT against Polio virus types 1-3 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5400
Study Start Date: March 2007
Estimated Study Completion Date: September 2011
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Seroimmunity 2007
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.
Sub Study
800 immigrated children (14 - 16 years) from which blood samples are taken.

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Seroimmunity 2007: the Swedish population.

Sub study: foreign born children between 14-16 years of age.

Criteria

Inclusion Criteria:

  • informed written consent (both groups)
  • immigrated to Sweden after 6 years of age from a country with polio vaccination coverage < 85 % (Sub study group)
  • living and attending school in Stockholm, Gothenburg or Malmoe (Sub study group)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932269

Locations
Sweden
Swedish Institute for Infectious Disease Control
Solna, Sweden, 171 82
Sponsors and Collaborators
Swedish Institute for Infectious Disease Control
Investigators
Study Director: Rigmor Thorstensson, Assoc. Prof. Swedish Institute for Infectious Disease Control
Principal Investigator: Eva Netterlid Swedish Institute for Infectious Disease Control
  More Information

No publications provided by Swedish Institute for Infectious Disease Control

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assoc. Prof. Rigmor Thorstensson, Swedish Institute for Infectious Disease Control
ClinicalTrials.gov Identifier: NCT00932269     History of Changes
Other Study ID Numbers: 2007/132-31/4//2008/164-32
Study First Received: June 30, 2009
Last Updated: July 1, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Swedish Institute for Infectious Disease Control:
Diphtheria
Tetanus
Pertussis
Polio
Haemophilus influenzae type B
Hib
Measles
Mumps
Rubella
Hepatitis B
Vaccine
Vaccination
Immunity
Vaccination program
Sweden
ELISA

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis B
Rubella
Actinomycetales Infections
Bacterial Infections
Corynebacterium Infections
Digestive System Diseases
DNA Virus Infections
Gram-Positive Bacterial Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014