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
| ISRCTN | ISRCTN57878347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57878347 |
| EudraCT/CTIS number | 2011-005102-30 |
| ClinicalTrials.gov number | NCT01443416 |
| Secondary identifying numbers | 12221 |
- Submission date
- 29/06/2012
- Registration date
- 29/06/2012
- Last edited
- 13/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Faye Alexander
Scientific
Scientific
Department of Paediatrics
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 1865 857420 |
|---|---|
| faye.alexander@paediatrics.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | 11/SC/0473; First MREC approval date 22/12/2011 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 05/04/2012 |
| Completion date | 31/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 12 Months |
| Sex | Both |
| Target number of participants | Planned Sample Size: 168; UK Sample Size: 168 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/04/2012 |
| Date of final enrolment | 31/10/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Paediatrics, Headley Way , Headington
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
Research Services
Clinical Trials and Research Governance
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Industry
GlaxoSmithKline
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/03/2018: Publication reference added.
14/02/2018: No publications found in PubMed, verifying study status with principal investigator.
18/12/2015: No publications found in PubMed.
