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

July 1, 2009 updated by: Swedish Institute for Infectious Disease Control

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.

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.

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

5400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Solna, Sweden, 171 82
        • Swedish Institute for Infectious Disease Control

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Seroimmunity 2007: the Swedish population.

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

July 3, 2009

Last Update Submitted That Met QC Criteria

July 1, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/132-31/4//2008/164-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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