Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease - Full Text View

Sponsored by:	Swedish Institute for Infectious Disease Control
Information provided by:	Swedish Institute for Infectious Disease Control
ClinicalTrials.gov Identifier:	NCT00932269

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:	Cohort, 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:

MedlinePlus related topics: Childhood Immunization Diphtheria Flu Hepatitis Hepatitis B Measles Mumps Polio and Post-Polio Syndrome Rubella Tetanus Whooping Cough

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Responsible Party:	Swedish Institute for Infectious Disease Control ( Assoc. Prof. Rigmor Thorstensson )
Study ID Numbers:	2007/132-31/4//2008/164-32
Study First Received:	June 30, 2009
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00932269 History of Changes
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

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Measles
Whooping Cough
Hepatitis, Viral, Human
Orthomyxoviridae Infections
Tetanus
Rubella
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hepatitis B

Paramyxoviridae Infections
Haemophilus Influenzae
Cough
Diphtheria
Togaviridae Infections
Hepatitis
Virus Diseases
Digestive System Diseases
Poliomyelitis
Influenza, Human
DNA Virus Infections
Clostridium Infections
Mumps

Additional relevant MeSH terms:

Bacterial Infections
Liver Diseases
Morbillivirus Infections
Measles
Whooping Cough
Hepatitis, Viral, Human
Orthomyxoviridae Infections
Infection
Tetanus
Rubella
Hepadnaviridae Infections
Gram-Negative Bacterial Infections
Rubivirus Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections

Respiratory Tract Diseases
Corynebacterium Infections
Hepatitis B
RNA Virus Infections
Paramyxoviridae Infections
Diphtheria
Togaviridae Infections
Actinomycetales Infections
Bordetella Infections
Hepatitis
Virus Diseases
Digestive System Diseases
Influenza, Human
DNA Virus Infections
Clostridium Infections

ClinicalTrials.gov processed this record on September 10, 2009