Pneumococcal InfectionsPhase 4sched1NCT00197808
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
A Phase 4 study testing menjugate, Men C conjugate vaccine and Men C conjugate in people with Pneumococcal Infections and Meningococcal Infections, run by Public Health England at 2 sites in United Kingdom.
Trial summary
The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age. Read more about this study
- Who is it for?
- Ages 7 to 11 weeksHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections, Meningococcal Infections
- What is being tested?
- menjugate, Men C conjugate vaccine and Men C conjugate
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2005to Jan 2010
- Phase
- Phase 4
- 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 7 to 11 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent obtained from parent or legal guardian of infant
- Age 7-11 weeks at first dose
Who cannot join
- Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996)
- < 7 weeks or > 11 weeks at first dose
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Gloucestershire Primary Care Trusts
Gloucester, GL1 3NN
Hertfordshire Primary Care Trusts
Welwyn Garden City, Hertfordshire, AL8 6JL
About this study
The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.
- Conditions
- Pneumococcal Infections, Meningococcal Infections
- Being tested
- menjugate, Men C conjugate vaccine, Men C conjugate
- Keywords
- Streptococcus pneumoniae, Neisseria meningitidis
- Medical subject headings
- Pneumococcal Infections, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menjugateBiological
men C conjugate vaccine
Men C conjugate vaccineBiological
men C conjugate vaccine
Men C conjugateBiological
men C conjugate vaccine
Men C ConjugateBiological
men C conjugate vaccine
Men C conjugateBiological
men C conjugate vaccine
Men C conjugateBiological
men C conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| Vaccine schedule 1 | Experimental | Menjugate vaccine at 2 and 3 months Receives: Biological: menjugate |
| Vaccine schedule 2 | Experimental | Menjugate vaccine at 2 and 4 months Receives: Biological: Men C conjugate vaccine |
| vaccine schedule3 | Experimental | Neissvacc at 2 and 3 months Receives: Biological: Men C conjugate |
| vaccine schedule 4 | Experimental | Neissvacc at 2 and 4 months Receives: Biological: Men C Conjugate |
| Vaccine schedule 5 | Experimental | Meningitec at 2 and 3 months Receives: Biological: Men C conjugate |
| Vaccine schedule 6 | Experimental | Meningitec at 2 and 4 months Receives: Biological: Men C conjugate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
SBA men C responses
Measured: 3 months after last sample
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 startApr 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elizabeth Coates, PhD, Study chair, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197808
- Sponsor's protocol ID
- sched1
- Acronym
- sched1
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2005
- Last updated
- 1 Oct 2020
- Results posted
- No
Publications
Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 2006 Apr;25(4):312-9. doi: 10.1097/01.inf.0000207483.60267.e7.
PubMed 16567982Goldblatt D, Southern J, Ashton L, Andrews N, Woodgate S, Burbidge P, Waight P, Miller E. Immunogenicity of a reduced schedule of pneumococcal conjugate vaccine in healthy infants and correlates of protection for serotype 6B in the United Kingdom. Pediatr Infect Dis J. 2010 May;29(5):401-5. doi: 10.1097/INF.0b013e3181c67f04.
PubMed 20010312
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
- ClinicalTrials.gov ID
- NCT00197808
- Acronym / sponsor ID
- sched1 / sched1
- Conditions
- Pneumococcal Infections, Meningococcal Infections
- Keywords
- Streptococcus pneumoniae, Neisseria meningitidis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Apr 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (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.
The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Vaccine schedule 1 | Experimental | Biological: menjugateMenjugate vaccine at 2 and 3 months |
| Vaccine schedule 2 | Experimental | Biological: Men C conjugate vaccineMenjugate vaccine at 2 and 4 months |
| vaccine schedule3 | Experimental | Biological: Men C conjugateNeissvacc at 2 and 3 months |
| vaccine schedule 4 | Experimental | Biological: Men C ConjugateNeissvacc at 2 and 4 months |
| Vaccine schedule 5 | Experimental | Biological: Men C conjugateMeningitec at 2 and 3 months |
| Vaccine schedule 6 | Experimental | Biological: Men C conjugateMeningitec at 2 and 4 months |
Who may qualify
- Ages
- 7 to 11 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Written informed consent obtained from parent or legal guardian of infant
- Age 7-11 weeks at first dose
Key exclusion criteria (2 listed)
- Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996)
- < 7 weeks or > 11 weeks at first dose
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 |
|---|---|---|
| menjugatemen C conjugate vaccine | Biological | Vaccine schedule 1 |
| Men C conjugate vaccinemen C conjugate vaccine | Biological | Vaccine schedule 2 |
| Men C conjugatemen C conjugate vaccine | Biological | vaccine schedule3 |
| Men C Conjugatemen C conjugate vaccine | Biological | vaccine schedule 4 |
| Men C conjugatemen C conjugate vaccine | Biological | Vaccine schedule 5 |
| Men C conjugatemen C conjugate vaccine | Biological | Vaccine schedule 6 |
Primary outcome
Immunogenicity
Time frame: 3 months after last sample
SBA men C 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 1 Oct 2020.
- Results publication: PubMed 16567982Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 2006 Apr;25(4):312-9. doi: 10.1097/01.inf.0000207483.60267.e7.
- Derived from this study: PubMed 20010312Goldblatt D, Southern J, Ashton L, Andrews N, Woodgate S, Burbidge P, Waight P, Miller E. Immunogenicity of a reduced schedule of pneumococcal conjugate vaccine in healthy infants and correlates of protection for serotype 6B in the United Kingdom. Pediatr Infect Dis J. 2010 May;29(5):401-5. doi: 10.1097/INF.0b013e3181c67f04.
- Published study resultsLink 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 Coates, PhD study chair
Public Health England
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing menjugate, Men C conjugate vaccine and Men C conjugate in people with Pneumococcal Infections and Meningococcal Infections, run by Public Health England at 2 sites 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 2 inclusion and 2 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 3 months after last sample). 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 NCT00197808, which also lists 2 linked publications.
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 1 Oct 2020.