Contact information
Type
Scientific
Primary contact
Mrs Faye Alexander
ORCID ID
Contact details
Department of Paediatrics
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 1865 857420
faye.alexander@paediatrics.ox.ac.uk
Additional identifiers
EudraCT number
2011-005102-30
ClinicalTrials.gov number
NCT01443416
Protocol/serial number
12221
Study information
Scientific title
A phase III randomised, open label clinical trial evaluating the immunogenicity of a 10-valent pneumococcal conjugate vaccine booster compared to the standard 13-valent pneumococcal conjugate vaccine booster given at 12 months of age to healthy children who have received the 13-valent pneumococcal conjugate vaccine at 2 and 4 months of age
Acronym
Study hypothesis
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, a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal types attached to a molecule (carrier protein) called CRM197, is 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 given at 12 months of age. Although PHiDCV contains only 10 pneumococcal types, there is evidence that it generates crossreactive antibodies against two of the three additional types included in PCV-13 which might be enough to protect children against these disease types. 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.
More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12221
Ethics approval
11/SC/0473; First MREC approval date 22/12/2011
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Streptococcus pneumoniae vaccination
Intervention
Blood sampling: Study nurse/doctor at the participants' home.
Diary cards: Participants will be asked to record any local/general reactions to vaccine for 4 days after vaccination. In addition any medically significant adverse events occuring between the study visits are to be recorded. All concomitant medication used during this period will also be recorded.
Health assessment: Study nurse/doctor at the participants' home.
Routine vaccines: MMR-Hib-MenC
Study vaccine and comparator, Study nurse/doctor at the participants' home
Taking oral temperature, Prior to receive the vaccine, oral temperature will be recorded at the CCVTM clinic rooms
Study Entry : Single Randomisation only
Intervention type
Biological/Vaccine
Phase
Phase III
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
05/04/2012
Overall trial end date
31/10/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 12 months (2 weeks to +6 weeks) at time of enrolment
2. Have received two doses of PCV13 at less than 6 months of age with a gap of at least 6 weeks between the two vaccinations
3. Have received all primary vaccines according to the UK routine immunisation schedule
4. Available for entire study period and whose parent/legal guardian can be reached by telephone
5. 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
6. Parent/legal guardian must be able to complete all relevant study procedures during study participation
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 168; UK Sample Size: 168
Participant exclusion criteria
1. Previous receipt of pneumococcal vaccine other than the 13 valent pneumococcal conjugate vaccine (Prevenar 13®, Pfizer)
2. Receipt of the routine 12month immunisations (PCV13 (3rd dose), combined Haemophilus influenzae type b and serogroup C meningococcal glycoconjugate vaccine (HibMenC) or measles, mumps and rubella vaccine (MMR)
3. A previous anaphylactic reaction to any vaccine or vaccinerelated component
4. Contraindication to vaccination with pneumococcal conjugate vaccine
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
6. Known or suspected immune deficiency or suppression
7. History of cultureproven invasive disease caused by S. pneumoniae
8. Major known congenital malformation or serious chronic disorder
9. 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
10. Receipt of blood products or gammaglobulin (including hepatitis B immunoglobulin and monoclonal antibodies; e.g., Synagis B)
11. Parents who plan to move out of the geographical area where the study would be conducted
Recruitment start date
05/04/2012
Recruitment end date
31/10/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Paediatrics, Headley Way , Headington
Oxford
OX3 9DU
United Kingdom
Funders
Funder type
Industry
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27088583