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

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ClinicalTrials.gov Identifier: NCT00932269
Recruitment Status : Unknown
Verified July 2009 by Swedish Institute for Infectious Disease Control.
Recruitment status was:  Active, not recruiting
First Posted : July 3, 2009
Last Update Posted : July 3, 2009
Sponsor:
Information provided by:
Swedish Institute for Infectious Disease Control

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.

Condition or disease
Diphtheria Tetanus Pertussis Polio Haemophilus Influenzae Type B Measles Mumps Rubella Hepatitis B

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
Estimated Enrollment : 5400 participants
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.
Study Start Date : March 2007
Actual Primary Completion Date : May 2008
Estimated Study Completion Date : September 2011


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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: July 3, 2009
Last Verified: July 2009

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:
Hepatitis
Hepatitis B
Whooping Cough
Tetanus
Diphtheria
Measles
Rubella
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Vaccines