Streptococcus PneumoniaePhase 2NCT00197821
Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults
A Phase 2 study testing pneumococcal conjugate vaccine in people with Streptococcus Pneumoniae, run by Public Health England.
Trial summary
To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae
- What is being tested?
- pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- 611 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2008
- Phase
- Phase 2
- 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 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent for participation in the study; ages between 50 and 80 years at recruitment
Who cannot join
- Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent.
- Current participation in any other clinical trial
- Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study)
- Prior pneumococcal conjugate vaccine (PNC)
- 23 valent pneumococcal vaccine(PPV) in last 5 years
- Severe general or local reaction to a previous dose of PNC or PPV
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- Patients currently immunocompromised as listed in UK Handbook "Immunisation Against Infectious Disease" ed 1996
- Patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study
- Patients in whom pneumococcal vaccination (PPV) is currently recommended as per the UK Handbook "Immunisation Against Infectious Disease"
- Deferral of vaccination if acute systemic illness or temperature >38C on day of vaccination
About this study
To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.
- Conditions
- Streptococcus Pneumoniae
- Being tested
- pneumococcal conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumococcal conjugate vaccineBiological
Pneumococcal conjugate vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
ELISA based asssay for serotype specific pneumococcal responses
Measured: Completed by dec 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2008
- Study completionDec 2008
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 Streptococcus PneumoniaeStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Elizabeth Miller, Public Health England
- Investigators
- Elizabeth Miller, MBBS FRCPath, Principal investigator, Heath Protection Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197821
- Sponsor's protocol ID
- PNCA
- Status last verified
- Mar 2012
- First submitted
- 12 Sep 2005
- Last updated
- 28 Mar 2012
- Results posted
- No
Publications
Goldblatt D, Southern J, Andrews N, Ashton L, Burbidge P, Woodgate S, Pebody R, Miller E. The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clin Infect Dis. 2009 Nov 1;49(9):1318-25. doi: 10.1086/606046.
PubMed 19814624
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT00197821
- Acronym / sponsor ID
- PNCA
- Conditions
- Streptococcus Pneumoniae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Jan 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Sep 2005 (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.
To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent for participation in the study; ages between 50 and 80 years at recruitment
Key exclusion criteria (10 listed)
- Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent.
- Current participation in any other clinical trial
- Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study)
- Prior pneumococcal conjugate vaccine (PNC)
- 23 valent pneumococcal vaccine(PPV) in last 5 years
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 |
|---|---|---|
| pneumococcal conjugate vaccinePneumococcal conjugate vaccine | Biological | – |
Primary outcome
Immunogenicity
Time frame: Completed by dec 2008
ELISA based asssay for serotype specific pneumococcal responses
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 28 Mar 2012.
- Derived from this study: PubMed 19814624Goldblatt D, Southern J, Andrews N, Ashton L, Burbidge P, Woodgate S, Pebody R, Miller E. The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clin Infect Dis. 2009 Nov 1;49(9):1318-25. doi: 10.1086/606046.
- Related InfoLink provided by the sponsor.
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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.
Elizabeth Miller, MBBS FRCPath principal investigator
Heath Protection Agency
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pneumococcal conjugate vaccine in people with Streptococcus Pneumoniae, run by Public Health England.
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 1 inclusion and 10 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 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Immunogenicity (time frame: Completed by dec 2008). 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 NCT00197821, 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 28 Mar 2012.