Meningococcal InfectionsPhase 4Sched2NCT00625677
Study to Evaluate the Immune Response of United Kingdom (UK) Infants Receiving DTaP/Hib/IPV, Meningococcal C Conjugate and Pneumococcal Conjugate Vaccines, Antibody Persistence and Responses to Booster Doses in the Second Year of Life
A Phase 4 study testing NeisVacC (Meningococcal C conjugate vaccine) and Menjugate (Meningococcal C conjugate vaccine) in people with Meningococcal Infections and Pneumococcal Infections, run by Public Health England at 2 sites in United Kingdom.
Trial summary
The purpose of this study is: To assess whether there are differences in antibody persistence eight months post primary (pre-booster) or in responses to the booster with regard to the Meningococcal C Conjugate (MCC) vaccine given in infancy. Read more about this study
- Who is it for?
- Ages 7 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections, Pneumococcal Infections
- What is being tested?
- NeisVacC (Meningococcal C conjugate vaccine) and Menjugate (Meningococcal C conjugate vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2008to Mar 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 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
- Written informed consent obtained from the parent or legal guardian of the infant
- Infant aged no less than 7 weeks exactly, and no more than 11 weeks 6 days
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Health Protection Agency
Gloucester
Health Protection Agency
London
About this study
Official title: A Phase IV, Randomized Study to Evaluate the Immune Response of UK Infants Receiving DTaP/Hib/IPV, Meningococcal C Conjugate and Pneumococcal Conjugate Vaccines, Antibody Persistence and Responses to Booster Doses in the Second Year of Life
The purpose of this study is:
To assess whether there are differences in antibody persistence eight months post primary (pre-booster) or in responses to the booster with regard to the Meningococcal C Conjugate (MCC) vaccine given in infancy.
To examine levels of diphtheria and tetanus antibody pre- and post-booster, with regard to the carrier proteins contained in the conjugate vaccines.
Read the detailed description
There is a well recognised benefit in reducing the number of injections included in an immunisation programme, particularly for infants where delivery of many antigens in the first few months of life is essential in providing protection against deadly diseases. Reducing the number of injections would reduce distress to infants, parents and healthcare workers, make the schedule as cost effective as possible and would give greater flexibility to include vaccination against novel antigens in the future.
The UK recommended immunisation schedule up to 13 months of age was revised from 4 September 2006 so that infants receive three doses of Pediacel (diphtheria, tetanus, whooping cough, Hib and polio containing vaccine), two doses of Prevenar (pneumococcal vaccine, PNC) and two doses of meningococcal C vaccine, MCC, which can be one of three licensed products, Meningitec, Menjugate or NeisVacC. Previous studies have however shown that these three MCC products behave quite differently from each other when given with other vaccines and under different dose schedules. To that end the two products which seem viable as single dose options under the UK schedule, Menjugate and NeisvacC, will be included in this study.
Assessment of the absolute number of doses of vaccine needed to protect against disease essential in maximising the efficiency of the schedule and this study will further examine the dose requirement for meningococcal C conjugate (MCC) vaccine where there are data to suggest that this would be possible, both in the published peer reviewed literature and in an ongoing study conducted by our group. This study will be the first to test this under the accelerated UK schedule and in the presence of pneumococcal conjugate vaccine. This study also includes a booster phase where children receive a dose of MCC, PNC and Hib in the second year of life in accordance with the national schedule. There is a need for boosters in the second year of life to increase circulating antibody which has dropped significantly by a year of age. As expected, responses to boosting have been shown to be significantly higher than those achieved after primary immunisation with variation between products following a similar pattern to that seen with the primary series.
The current study is designed to allow assessment of a single dose of MCC vaccine given at three months of age for the two products that have shown potential to afford protection in the ongoing study above. In the previous study the first dose was given at two months of age and as responses tend to improve with age it is anticipated that this single dose being given later will result in higher antibodies than seen in the above study.
The aim of this study will be to provide data on which to base a decision about a further reduction in MCC vaccination in infancy from two doses to a single dose which would afford the benefits discussed above.
- Conditions
- Meningococcal Infections, Pneumococcal Infections
- Being tested
- NeisVacC (Meningococcal C conjugate vaccine), Menjugate (Meningococcal C conjugate vaccine)
- Keywords
- meningococcal serogroup C vaccine, reduced dose, meningococcal serogroup C conjugate vaccine, pneumococcal conjugate vaccine
- Medical subject headings
- Meningococcal Infections, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeisVacC (Meningococcal C conjugate vaccine)Biological
Also called Meningococcal C conjugate vaccine, Neis-vacC
Dosage
Menjugate (Meningococcal C conjugate vaccine)Biological
Also called Meningococcal C conjugate vaccine, Menjugate
Dosage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pediacel - 2,3,4 months Prevenar - 2,4 months Menjugate - 3 months Hib/ pneumo conjugate/ Men C conjugate - 12 months
Blood collected - 4,5,12,13 months Receives: Biological: Menjugate (Meningococcal C conjugate vaccine) |
| 2 | Experimental | Pediacel - 2,3,4 months Prevenar - 2,4 months Neis-vacC - 3 months Hib/ pneumo conjugate/ Men C conjugate - 12 months
Blood collected - 4,5,12,13 months Receives: Biological: NeisVacC (Meningococcal C conjugate vaccine) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meningococcal 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Collaborators
- Institute of Child Health, National Institute of Biological Standards and Control
- Investigators
- Elizabeth Miller, BSc MBBS FFPHM FRCPath, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625677
- Sponsor's protocol ID
- Sched2
- Other IDs
- EudraCT No: 2007-004056-36
- Acronym
- Sched2
- Status last verified
- Sep 2010
- First submitted
- 19 Feb 2008
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller E, Andrews N, Waight P, Findlow H, Ashton L, England A, Stanford E, Matheson M, Southern J, Sheasby E, Goldblatt D, Borrow R. Safety and immunogenicity of coadministering a combined meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps, and rubella vaccine at 12 months of age. Clin Vaccine Immunol. 2011 Mar;18(3):367-72. doi: 10.1128/CVI.00516-10. Epub 2010 Dec 29.
PubMed 21191076Borrow R, Andrews N, Findlow H, Waight P, Southern J, Crowley-Luke A, Stapley L, England A, Findlow J, Miller E. Kinetics of antibody persistence following administration of a combination meningococcal serogroup C and haemophilus influenzae type b conjugate vaccine in healthy infants in the United Kingdom primed with a monovalent meningococcal serogroup C vaccine. Clin Vaccine Immunol. 2010 Jan;17(1):154-9. doi: 10.1128/CVI.00384-09. Epub 2009 Nov 11.
PubMed 19906895Southern J, Borrow R, Andrews N, Morris R, Waight P, Hudson M, Balmer P, Findlow H, Findlow J, Miller E. Immunogenicity of a reduced schedule of meningococcal group C conjugate vaccine given concomitantly with the Prevenar and Pediacel vaccines in healthy infants in the United Kingdom. Clin Vaccine Immunol. 2009 Feb;16(2):194-9. doi: 10.1128/CVI.00420-08. Epub 2008 Dec 17.
PubMed 19091990
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized Study to Evaluate the Immune Response of UK Infants Receiving DTaP/Hib/IPV, Meningococcal C Conjugate and Pneumococcal Conjugate Vaccines, Antibody Persistence and Responses to Booster Doses in the Second Year of Life
- ClinicalTrials.gov ID
- NCT00625677
- Acronym / sponsor ID
- Sched2 / Sched2
- Conditions
- Meningococcal Infections, Pneumococcal Infections
- Keywords
- meningococcal serogroup C vaccine, reduced dose, meningococcal serogroup C conjugate vaccine, pneumococcal conjugate vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Public Health EnglandOther government
- Collaborators
- Institute of Child Health, National Institute of Biological Standards and Control
- Study start
- Feb 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Feb 2008 (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 this study is:
To assess whether there are differences in antibody persistence eight months post primary (pre-booster) or in responses to the booster with regard to the Meningococcal C Conjugate (MCC) vaccine given in infancy.
To examine levels of diphtheria and tetanus antibody pre- and post-booster, with regard to the carrier proteins contained in the conjugate vaccines.
Detailed description
There is a well recognised benefit in reducing the number of injections included in an immunisation programme, particularly for infants where delivery of many antigens in the first few months of life is essential in providing protection against deadly diseases. Reducing the number of injections would reduce distress to infants, parents and healthcare workers, make the schedule as cost effective as possible and would give greater flexibility to include vaccination against novel antigens in the future.
The UK recommended immunisation schedule up to 13 months of age was revised from 4 September 2006 so that infants receive three doses of Pediacel (diphtheria, tetanus, whooping cough, Hib and polio containing vaccine), two doses of Prevenar (pneumococcal vaccine, PNC) and two doses of meningococcal C vaccine, MCC, which can be one of three licensed products, Meningitec, Menjugate or NeisVacC. Previous studies have however shown that these three MCC products behave quite differently from each other when given with other vaccines and under different dose schedules. To that end the two products which seem viable as single dose options under the UK schedule, Menjugate and NeisvacC, will be included in this study.
Assessment of the absolute number of doses of vaccine needed to protect against disease essential in maximising the efficiency of the schedule and this study will further examine the dose requirement for meningococcal C conjugate (MCC) vaccine where there are data to suggest that this would be possible, both in the published peer reviewed literature and in an ongoing study conducted by our group. This study will be the first to test this under the accelerated UK schedule and in the presence of pneumococcal conjugate vaccine. This study also includes a booster phase where children receive a dose of MCC, PNC and Hib in the second year of life in accordance with the national schedule. There is a need for boosters in the second year of life to increase circulating antibody which has dropped significantly by a year of age. As expected, responses to boosting have been shown to be significantly higher than those achieved after primary immunisation with variation between products following a similar pattern to that seen with the primary series.
The current study is designed to allow assessment of a single dose of MCC vaccine given at three months of age for the two products that have shown potential to afford protection in the ongoing study above. In the previous study the first dose was given at two months of age and as responses tend to improve with age it is anticipated that this single dose being given later will result in higher antibodies than seen in the above study.
The aim of this study will be to provide data on which to base a decision about a further reduction in MCC vaccination in infancy from two doses to a single dose which would afford the benefits discussed above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Menjugate (Meningococcal C conjugate vaccine)Pediacel - 2,3,4 months Prevenar - 2,4 months Menjugate - 3 months Hib/ pneumo conjugate/ Men C conjugate - 12 months Blood collected - 4,5,12,13 months |
| 2 | Experimental | Biological: NeisVacC (Meningococcal C conjugate vaccine)Pediacel - 2,3,4 months Prevenar - 2,4 months Neis-vacC - 3 months Hib/ pneumo conjugate/ Men C conjugate - 12 months Blood collected - 4,5,12,13 months |
Who may qualify
- Ages
- 7 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
- Written informed consent obtained from the parent or legal guardian of the infant
- Infant aged no less than 7 weeks exactly, and no more than 11 weeks 6 days
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| NeisVacC (Meningococcal C conjugate vaccine)Also: Meningococcal C conjugate vaccine, Neis-vacCDosage | Biological | 2 |
| Menjugate (Meningococcal C conjugate vaccine)Also: Meningococcal C conjugate vaccine, MenjugateDosage | Biological | 1 |
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 22 Mar 2019.
- Results publication: PubMed 21191076Miller E, Andrews N, Waight P, Findlow H, Ashton L, England A, Stanford E, Matheson M, Southern J, Sheasby E, Goldblatt D, Borrow R. Safety and immunogenicity of coadministering a combined meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps, and rubella vaccine at 12 months of age. Clin Vaccine Immunol. 2011 Mar;18(3):367-72. doi: 10.1128/CVI.00516-10. Epub 2010 Dec 29.
- Results publication: PubMed 19906895Borrow R, Andrews N, Findlow H, Waight P, Southern J, Crowley-Luke A, Stapley L, England A, Findlow J, Miller E. Kinetics of antibody persistence following administration of a combination meningococcal serogroup C and haemophilus influenzae type b conjugate vaccine in healthy infants in the United Kingdom primed with a monovalent meningococcal serogroup C vaccine. Clin Vaccine Immunol. 2010 Jan;17(1):154-9. doi: 10.1128/CVI.00384-09. Epub 2009 Nov 11.
- Results publication: PubMed 19091990Southern J, Borrow R, Andrews N, Morris R, Waight P, Hudson M, Balmer P, Findlow H, Findlow J, Miller E. Immunogenicity of a reduced schedule of meningococcal group C conjugate vaccine given concomitantly with the Prevenar and Pediacel vaccines in healthy infants in the United Kingdom. Clin Vaccine Immunol. 2009 Feb;16(2):194-9. doi: 10.1128/CVI.00420-08. Epub 2008 Dec 17.
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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, BSc MBBS FFPHM FRCPath principal investigator
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 NeisVacC (Meningococcal C conjugate vaccine) and Menjugate (Meningococcal C conjugate vaccine) in people with Meningococcal Infections and Pneumococcal 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 3 inclusion and 1 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 22 Mar 2019. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00625677, which also lists 3 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 22 Mar 2019.