Invasive Streptococcus Pneumoniae DiseasePhase 3NCT01443416
An Alternative Booster Vaccine Against Meningitis and Ear Infections
A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and 10-valent pneumococcal conjugate vaccine in people with Invasive Streptococcus Pneumoniae Disease, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at 2, 4… Read more about this study
- Who is it for?
- Ages 12 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Invasive Streptococcus Pneumoniae Disease
- What is being tested?
- 13-valent pneumococcal conjugate vaccine and 10-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Aug 2013
- Phase
- Phase 3
- 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 12 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 12 months (-2 weeks to +6 weeks) at time of enrolment.
- Have received two doses of PCV-13 at less than 6 months of age with a gap of at least 6 weeks between the two vaccinations.
- Have received all primary vaccines according to the UK routine immunisation schedule (up to, but not including, 12 months of age).
- Available for the entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy children as determined by medical history and physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator.
- Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Who cannot join
- Previous receipt of pneumococcal vaccine other than the 13-valent pneumococcal conjugate vaccine (Prevenar 13®, Pfizer).
- Receipt of the routine 12 month immunisations (PCV13 (3rd dose), combined Haemophilus influenzae type b and serogroup C meningococcal glyco-conjugate vaccine (Hib-MenC) or measles, mumps and rubella vaccine (MMR)).
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal conjugate vaccine.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
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- History of culture-proven invasive disease caused by S. pneumoniae.
- Major known congenital malformation or serious chronic disorder.
- Significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; e.g., Synagis B).
- Parents who plan to move out of the geographical area where the study would be conducted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Alternative Booster Vaccine Against Meningitis and Ear Infections.
This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two of the three additional serotypes included in PCV-13 which might be enough to protect children against disease caused by these two serotypes. Furthermore, previous studies have shown that PHiD-CV confers protection against a common otitis media pathogen in children called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D, which is derived from NTHi. In addition, the use of a carrier protein, which is not closely related to an antigen included in any coadministered or previously administered routine vaccine minimises the risk of interference related to it.
The investigators aim to recruit 168 healthy children at the age of 12 months who have already received two doses of PCV-13 according to the UK routine immunisation schedule at 2 and 4 months of age. Participants will then be randomised to receive a booster dose of either PCV-13 or PHiD-CV at 12 months of age.
Three visits will take place at their parents' home and will involve a blood test followed by a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month after visit 1) and 3 (1 year after visit 1).
Read the detailed description
Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two of the three additional serotypes included in PCV-13 which might be enough to protect children against disease caused by these two serotypes. Furthermore, previous studies have shown that PHiD-CV confers protection against a common otitis media pathogen in children called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D, which is derived from NTHi. In addition, the use of a carrier protein, which is not closely related to an antigen included in any coadministered or previously administered routine vaccine minimises the risk of interference related to it.
The investigators aim to recruit 168 healthy children at the age of 12 months who have already received two doses of PCV-13 according to the UK routine immunisation schedule at 2 and 4 months of age. Participants will then be randomised to receive a booster dose of either PCV-13 or PHiD-CV at 12 months of age.
Three visits will take place at their parents' home and will involve a blood test followed by a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month after visit 1) and 3 (1 year after visit 1).
- Being tested
- 13-valent pneumococcal conjugate vaccine, 10-valent pneumococcal conjugate vaccine
- Keywords
- pneumococcal conjugate vaccine, invasive pneumococcal disease, vaccination, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-valent pneumococcal conjugate vaccineBiological
The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age
10-valent pneumococcal conjugate vaccineBiological
The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age.
| Study group | Role | What they receive |
|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Experimental | 12 month booster dose of Prevenar Receives: Biological: 13-valent pneumococcal conjugate vaccine |
| 10-valent pneumococcal conjugate vaccine | Experimental | 12 month booster dose of Synflorix Receives: Biological: 10-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of participants who have IgG concentrations ≥0.35mcg/ml for 14 pneumococcal serotypes following vaccination with either Prevenar or Synflorix
To demonstrate non-inferiority (10% level) of a booster dose of PCV-10 compared to a booster dose of PCV-13 for proportion of participants who have serotype-specific IgG concentrations ≥0.35mcg/ml for the PHiD-CV serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) 1 month following booster vaccination.
Measured: One month after a 12 month booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startApr 2012
- Primary completionAug 2013
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 Invasive Streptococcus Pneumoniae DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Pollard, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443416
- Sponsor's protocol ID
- OVG 2011/05
- Status last verified
- Nov 2015
- First submitted
- 27 Sep 2011
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Truck J, Kelly S, Jawad S, Snape MD, Voysey M, Pollard AJ. Differences in Immunization Site Pain in Toddlers Vaccinated With Either the 10- or the 13-Valent Pneumococcal Conjugate Vaccine. Pediatr Infect Dis J. 2018 Apr;37(4):e103-e106. doi: 10.1097/INF.0000000000001894.
PubMed 29329169
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
- An Alternative Booster Vaccine Against Meningitis and Ear Infections.
- ClinicalTrials.gov ID
- NCT01443416
- Acronym / sponsor ID
- OVG 2011/05
- Keywords
- pneumococcal conjugate vaccine, invasive pneumococcal disease, vaccination, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2013 (actual)
- First posted
- 29 Sep 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.
This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two of the three additional serotypes included in PCV-13 which might be enough to protect children against disease caused by these two serotypes. Furthermore, previous studies have shown that PHiD-CV confers protection against a common otitis media pathogen in children called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D, which is derived from NTHi. In addition, the use of a carrier protein, which is not closely related to an antigen included in any coadministered or previously administered routine vaccine minimises the risk of interference related to it.
The investigators aim to recruit 168 healthy children at the age of 12 months who have already received two doses of PCV-13 according to the UK routine immunisation schedule at 2 and 4 months of age. Participants will then be randomised to receive a booster dose of either PCV-13 or PHiD-CV at 12 months of age.
Three visits will take place at their parents' home and will involve a blood test followed by a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month after visit 1) and 3 (1 year after visit 1).
Detailed description
Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two of the three additional serotypes included in PCV-13 which might be enough to protect children against disease caused by these two serotypes. Furthermore, previous studies have shown that PHiD-CV confers protection against a common otitis media pathogen in children called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D, which is derived from NTHi. In addition, the use of a carrier protein, which is not closely related to an antigen included in any coadministered or previously administered routine vaccine minimises the risk of interference related to it.
The investigators aim to recruit 168 healthy children at the age of 12 months who have already received two doses of PCV-13 according to the UK routine immunisation schedule at 2 and 4 months of age. Participants will then be randomised to receive a booster dose of either PCV-13 or PHiD-CV at 12 months of age.
Three visits will take place at their parents' home and will involve a blood test followed by a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month after visit 1) and 3 (1 year after visit 1).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Experimental | Biological: 13-valent pneumococcal conjugate vaccine12 month booster dose of Prevenar |
| 10-valent pneumococcal conjugate vaccine | Experimental | Biological: 10-valent pneumococcal conjugate vaccine12 month booster dose of Synflorix |
Who may qualify
- Ages
- 12 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 12 months (-2 weeks to +6 weeks) at time of enrolment.
- Have received two doses of PCV-13 at less than 6 months of age with a gap of at least 6 weeks between the two vaccinations.
- Have received all primary vaccines according to the UK routine immunisation schedule (up to, but not including, 12 months of age).
- Available for the entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy children as determined by medical history and physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator.
Key exclusion criteria (11 listed)
- Previous receipt of pneumococcal vaccine other than the 13-valent pneumococcal conjugate vaccine (Prevenar 13®, Pfizer).
- Receipt of the routine 12 month immunisations (PCV13 (3rd dose), combined Haemophilus influenzae type b and serogroup C meningococcal glyco-conjugate vaccine (Hib-MenC) or measles, mumps and rubella vaccine (MMR)).
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal conjugate vaccine.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
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 |
|---|---|---|
| 13-valent pneumococcal conjugate vaccineThe vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age | Biological | 13-valent pneumococcal conjugate vaccine |
| 10-valent pneumococcal conjugate vaccineThe vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age. | Biological | 10-valent pneumococcal conjugate vaccine |
Primary outcome
Proportions of participants who have IgG concentrations ≥0.35mcg/ml for 14 pneumococcal serotypes following vaccination with either Prevenar or Synflorix
Time frame: One month after a 12 month booster vaccination
To demonstrate non-inferiority (10% level) of a booster dose of PCV-10 compared to a booster dose of PCV-13 for proportion of participants who have serotype-specific IgG concentrations ≥0.35mcg/ml for the PHiD-CV serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) 1 month following booster vaccination.
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 29329169Truck J, Kelly S, Jawad S, Snape MD, Voysey M, Pollard AJ. Differences in Immunization Site Pain in Toddlers Vaccinated With Either the 10- or the 13-Valent Pneumococcal Conjugate Vaccine. Pediatr Infect Dis J. 2018 Apr;37(4):e103-e106. doi: 10.1097/INF.0000000000001894.
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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.
Andrew Pollard principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and 10-valent pneumococcal conjugate vaccine in people with Invasive Streptococcus Pneumoniae Disease, 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 6 inclusion and 11 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportions of participants who have IgG concentrations ≥0.35mcg/ml for 14 pneumococcal serotypes following vaccination with either Prevenar or Synflorix (time frame: One month after a 12 month booster vaccination). 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 NCT01443416, 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.