Back to resultsAn Alternative Booster Vaccine Against Meningitis and Ear Infections
Primary Purpose
Invasive Streptococcus Pneumoniae Disease
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
13-valent pneumococcal conjugate vaccine
10-valent pneumococcal conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Invasive Streptococcus Pneumoniae Disease focused on measuring pneumococcal conjugate vaccine, invasive pneumococcal disease, vaccination, children
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Oxford Vaccine Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
13-valent pneumococcal conjugate vaccine
10-valent pneumococcal conjugate vaccine
Arm Description
12 month booster dose of Prevenar
12 month booster dose of Synflorix
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01443416
First Posted
September 27, 2011
Last Updated
November 6, 2015
Sponsor
University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT01443416
Brief Title
An Alternative Booster Vaccine Against Meningitis and Ear Infections
Official Title
An Alternative Booster Vaccine Against Meningitis and Ear Infections.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Streptococcus Pneumoniae Disease
Keywords
pneumococcal conjugate vaccine, invasive pneumococcal disease, vaccination, children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
13-valent pneumococcal conjugate vaccine
Arm Type
Experimental
Arm Description
12 month booster dose of Prevenar
Arm Title
10-valent pneumococcal conjugate vaccine
Arm Type
Experimental
Arm Description
12 month booster dose of Synflorix
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine
Intervention Description
The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age
Intervention Type
Biological
Intervention Name(s)
10-valent pneumococcal conjugate vaccine
Intervention Description
The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age.
Primary Outcome Measure Information:
Title
Proportions of participants who have IgG concentrations ≥0.35mcg/ml for 14 pneumococcal serotypes following vaccination with either Prevenar or Synflorix
Description
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.
Time Frame
One month after a 12 month booster vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
13 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Pollard
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Vaccine Group
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29329169
Citation
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.
Results Reference
derived
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An Alternative Booster Vaccine Against Meningitis and Ear Infections
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