DiphtheriaSero 2007NCT00932269
Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease
An observational study of Diphtheria and Tetanus, run by Swedish Institute for Infectious Disease Control at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- How many people
- 5,400 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Seroimmunity 2007: the Swedish population. Sub study: foreign born children between 14-16 years of age.
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio, Haemophilus Influenzae Type B, Measles
- Keywords
- Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type B, Hib, Measles, Mumps, Rubella, Hepatitis B, Vaccine, Vaccination, Immunity, Vaccination program, Sweden, ELISA
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Haemophilus Infections, Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish Institute for Infectious Disease Control
- Sponsor type
- University, hospital or other
- Investigators
- Rigmor Thorstensson, Assoc. Prof., Study director, Swedish Institute for Infectious Disease ControlEva Netterlid, Principal investigator, Swedish Institute for Infectious Disease Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932269
- Sponsor's protocol ID
- 2007/132-31/4//2008/164-32
- Acronym
- Sero 2007
- Status last verified
- Jul 2009
- First submitted
- 30 Jun 2009
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20955461
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00932269
- Acronym / sponsor ID
- Sero 2007 / 2007/132-31/4//2008/164-32
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio, Haemophilus Influenzae Type B, Measles
- Keywords
- Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type B, Hib, Measles, Mumps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Swedish Institute for Infectious Disease ControlUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2011 (estimated)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Seroimmunity 2007: the Swedish population. Sub study: foreign born children between 14-16 years of age.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2009.
- Derived from this study: PubMed 20955461Hallander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rigmor Thorstensson, Assoc. Prof. study director
Swedish Institute for Infectious Disease Control
Eva Netterlid principal investigator
Swedish Institute for Infectious Disease Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diphtheria and Tetanus, run by Swedish Institute for Infectious Disease Control at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2009.