NCT00932269

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 3, 2009

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

June 30, 2009

Last Update Submit

July 1, 2009

Conditions

DiphtheriaTetanusPertussisPolioHaemophilus Influenzae Type BMeaslesMumpsRubellaHepatitis B

Keywords

DiphtheriaTetanusPertussisPolioHaemophilus influenzae type BHibMeaslesMumpsRubellaHepatitis BVaccineVaccinationImmunityVaccination programSwedenELISA

Outcome Measures

Primary Outcomes (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

    3 years

Secondary Outcomes (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

    3 years

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Seroimmunity 2007: the Swedish population. Sub study: foreign born children between 14-16 years of age.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Institute for Infectious Disease Control

Solna, 171 82, Sweden

Location

Related Publications (1)

  • Hallander HO, Lepp T, Ljungman M, Netterlid E, Andersson M. Do we need a booster of Hib vaccine after primary vaccination? A study on anti-Hib seroprevalence in Sweden 5 and 15 years after the introduction of universal Hib vaccination related to notifications of invasive disease. APMIS. 2010 Nov;118(11):878-87. doi: 10.1111/j.1600-0463.2010.02674.x. Epub 2010 Sep 2.

    PMID: 20955461DERIVED

MeSH Terms

Conditions

DiphtheriaTetanusWhooping CoughPoliomyelitisHaemophilus InfectionsMeaslesMumpsRubellaHepatitis B

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesPasteurellaceae InfectionsMorbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae InfectionsBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Rigmor Thorstensson, Assoc. Prof.

    Swedish Institute for Infectious Disease Control

    STUDY DIRECTOR

  • Eva Netterlid

    Swedish Institute for Infectious Disease Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 3, 2009

Study Start

March 1, 2007

Primary Completion

May 1, 2008

Study Completion

September 1, 2011

Last Updated

July 3, 2009

Record last verified: 2009-07

Locations

SE(1)