Condition category
Infections and Infestations
Date applied
29/06/2012
Date assigned
29/06/2012
Last edited
18/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Topic: Medicines for Children Research Network, Primary Care Research Network for England; Subtopic: All Diagnoses, Not Assigned; Disease: All Diseases, All Diseases

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 measures

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

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

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Research Services
Clinical Trials and Research Governance
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/12/2015: No publications found in PubMed.