Antibody Persistance After Booster Dose of Men C VaccineNCT01459432
Understanding Immunity Persistence After Adolescent MenC Vaccination
An observational study of Antibody Persistance After Booster Dose of Men C Vaccine, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to… Read more about this study
- Who is it for?
- Ages 20 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibody Persistance After Booster Dose of Men C Vaccine
- What is being tested?
- Venepuncture and blood sample collection.
- How many people
- 134 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Apr 2012
- 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 20 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults, approximately 20 - 23 years old.
Who may be able to join
- Participants who completed clinical study M14P2E1
- Participant who are willing to participate and who would be expected to comply with the requirements of the protocol
- Participants who have given informed consent for participation in the study
Who cannot join
- History of invasive meningococcal C disease (or any case of invasive meningococcal disease where the serotype was unknown)
- Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection
- Severe blood clotting disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Persistence of Antibody Seven Years After a Booster Dose of Either a Glycoconjugate or a Polysaccharide Vaccine Against Serogroup C Neisseria Meningitidis Given to Adolescents
The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to transmit it to other members of the population. If a booster dose of MenC vaccine given to adolescents does produce protective levels of antibody which persist into early adulthood, this would strengthen the case for such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a resurgence of the disease in the future.
- Being tested
- Venepuncture and blood sample collection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venepuncture and blood sample collection.Other
Venepuncture and blood sample collection.
| Study group | Role | What they receive |
|---|---|---|
| Follow-on blood sample from previous study | Not described Receives: Other: Venepuncture and blood sample collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with rSBA titre ≥1:8 (correlate of protection).
Measured: 4 months
Secondary outcomes (1)
Geometric mean titre (GMT) rSBA.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
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 Antibody Persistance After Booster Dose of Men C VaccineStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459432
- Sponsor's protocol ID
- OVG 2011/03
- Status last verified
- Nov 2015
- First submitted
- 21 Oct 2011
- Last updated
- 9 Nov 2015
- Results posted
- No
Publications
de Whalley PC, Snape MD, Plested E, Thompson B, Nuthall E, Omar O, Borrow R, Pollard AJ. Long-term seroprotection after an adolescent booster meningococcal serogroup C vaccination. Arch Dis Child. 2013 Sep;98(9):686-91. doi: 10.1136/archdischild-2013-303893. Epub 2013 Jul 13.
PubMed 23853000
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Persistence of Antibody Seven Years After a Booster Dose of Either a Glycoconjugate or a Polysaccharide Vaccine Against Serogroup C Neisseria Meningitidis Given to Adolescents
- ClinicalTrials.gov ID
- NCT01459432
- Acronym / sponsor ID
- OVG 2011/03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- First posted
- 25 Oct 2011 (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.
The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to transmit it to other members of the population. If a booster dose of MenC vaccine given to adolescents does produce protective levels of antibody which persist into early adulthood, this would strengthen the case for such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a resurgence of the disease in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-on blood sample from previous study | – | Other: Venepuncture and blood sample collection. |
Who may qualify
- Ages
- 20 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults, approximately 20 - 23 years old.
Key inclusion criteria (3 listed)
- Participants who completed clinical study M14P2E1
- Participant who are willing to participate and who would be expected to comply with the requirements of the protocol
- Participants who have given informed consent for participation in the study
Key exclusion criteria (3 listed)
- History of invasive meningococcal C disease (or any case of invasive meningococcal disease where the serotype was unknown)
- Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection
- Severe blood clotting disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venepuncture and blood sample collection.Venepuncture and blood sample collection. | Other | Follow-on blood sample from previous study |
Primary outcome
Percentage of participants with rSBA titre ≥1:8 (correlate of protection).
Time frame: 4 months
1 secondary outcome
Geometric mean titre (GMT) rSBA.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
- Derived from this study: PubMed 23853000de Whalley PC, Snape MD, Plested E, Thompson B, Nuthall E, Omar O, Borrow R, Pollard AJ. Long-term seroprotection after an adolescent booster meningococcal serogroup C vaccination. Arch Dis Child. 2013 Sep;98(9):686-91. doi: 10.1136/archdischild-2013-303893. Epub 2013 Jul 13.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Antibody Persistance After Booster Dose of Men C Vaccine, run by University of Oxford at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 9 Nov 2015. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants with rSBA titre ≥1:8 (correlate of protection). (time frame: 4 months). 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 NCT01459432, 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 9 Nov 2015.