Streptococcus PneumoniaePhase 2NCT00197769
Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants
A Phase 2 study testing 9 valent pneumococcal con jugate vaccine in people with Streptococcus Pneumoniae, run by Public Health England.
Trial summary
The purpose of the trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect UK infants and toddlers Read more about this study
- Who is it for?
- Ages 7 weeks to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae
- What is being tested?
- 9 valent pneumococcal con jugate vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2000to Jan 2004
- 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 7 weeks to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent by parent/guardian for receipt of study vaccines and for blood samples
- Age at first dose: Infants 7-11 weeks; toddlers 12-18 months
Who cannot join
- Previous bacteriologically confirmed pneumococcal or meningococcal disease
- Contraindications for pneumococcal, meningococcal, Hib, DTP, MMR immunisations as listed in the UK handbook, "Immunisation Against Infectious Disease" Edition 1996.
- Language difficulty in parents sufficient to preclude adequate comprehension of the information sheet, consent form and study nurses' explanation of the study
- Children participating in any other clinical trial
- Immunocompromised
- Acute systemic illness or fever > 38C on day of vaccination - deferral
About this study
The purpose of the trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect UK infants and toddlers
Read the detailed description
A new vaccine against pneumococcal infection is now available in the UK and has already been in routine use in the US for five years. The purpose of the trial is to determine the minimum number of does required to protect UK infants and toddlers, and to assess the compatibility of the pneumococcal vaccine with the other vaccines given in the UK childhood immunisation programme. The vaccine used in the US protects against seven strains of pnemococcus whereas the vaccine used in this trial protects against nine strains. Infants received either two doses at two and four months or three doses at two, three and four months of age, the latter comprising the routine infant schedule for other paediatric vaccines in the UK. The infants also received the usual vaccines against diphtheria , tetanus, polio, whooping cough and Hib together with meningitis C vaccine which is currently only used in the UK and a few other countries worldwide. A group of toddlers aged twelve to fifteen months also took apart and received either one or two doses of pneumococcal vaccine around the same time as their MMR vaccine. All children in the study received a booster dose some months later. The response to the vaccine is assessed by measuring levels of protective antibodies to the pneumococcal strains in blood samples taken at various times during the immunisation schedule.
- Conditions
- Streptococcus Pneumoniae
- Being tested
- 9 valent pneumococcal con jugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9 valent pneumococcal con jugate vaccineBiological
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 startSep 2000
- Study completionJan 2004
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
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Investigators
- Elizabeth Miller, MBBS FRCPath, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197769
- Sponsor's protocol ID
- PNC1/2
- Status last verified
- Feb 2008
- First submitted
- 12 Sep 2005
- Last updated
- 29 Aug 2018
- 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 16567982
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants
- ClinicalTrials.gov ID
- NCT00197769
- Acronym / sponsor ID
- PNC1/2
- Conditions
- Streptococcus Pneumoniae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Sep 2000
- Study completion
- Jan 2004
- 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 trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect UK infants and toddlers
Detailed description
A new vaccine against pneumococcal infection is now available in the UK and has already been in routine use in the US for five years. The purpose of the trial is to determine the minimum number of does required to protect UK infants and toddlers, and to assess the compatibility of the pneumococcal vaccine with the other vaccines given in the UK childhood immunisation programme. The vaccine used in the US protects against seven strains of pnemococcus whereas the vaccine used in this trial protects against nine strains. Infants received either two doses at two and four months or three doses at two, three and four months of age, the latter comprising the routine infant schedule for other paediatric vaccines in the UK. The infants also received the usual vaccines against diphtheria , tetanus, polio, whooping cough and Hib together with meningitis C vaccine which is currently only used in the UK and a few other countries worldwide. A group of toddlers aged twelve to fifteen months also took apart and received either one or two doses of pneumococcal vaccine around the same time as their MMR vaccine. All children in the study received a booster dose some months later. The response to the vaccine is assessed by measuring levels of protective antibodies to the pneumococcal strains in blood samples taken at various times during the immunisation schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 7 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Informed consent by parent/guardian for receipt of study vaccines and for blood samples
- Age at first dose: Infants 7-11 weeks; toddlers 12-18 months
Key exclusion criteria (6 listed)
- Previous bacteriologically confirmed pneumococcal or meningococcal disease
- Contraindications for pneumococcal, meningococcal, Hib, DTP, MMR immunisations as listed in the UK handbook, "Immunisation Against Infectious Disease" Edition 1996.
- Language difficulty in parents sufficient to preclude adequate comprehension of the information sheet, consent form and study nurses' explanation of the study
- Children participating in any other clinical trial
- Immunocompromised
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 |
|---|---|---|
| 9 valent pneumococcal con jugate vaccine | Biological | – |
Primary outcome
Not reported in the source record.
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 29 Aug 2018.
- 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.
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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
Public Health England
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 9 valent pneumococcal con jugate 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 2 inclusion and 6 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 29 Aug 2018. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197769, 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 29 Aug 2018.