Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8092
Study information
Scientific title
A follow-on, multicentre, open-label, clinical, phase IV trial to investigate the persistence of serotype-specific antibodies at 40 months of age in children who have received either the 7-valent or the 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age and assessing the immunogenicity of a 13-valent pneumococcal conjugate vaccine booster dose given at 40 months of age
Acronym
Study hypothesis
1. Investigating the persistence of serotype-specific antibodies at 40 months of age in children who have received either a 7-valent or 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age
2. Assessing the immunogenicity of a 13-valent pneumococcal conjugate vaccine booster dose at 40 months of age
Ethics approval
Oxfordshire REC C approved on the 18/03/2010 (ref: 10/H0606/9)
Study design
Non-randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention
Study vaccine: 13-Valent Pneumococcal Conjugate Vaccine. Intramuscular administration on the deltoid area of the non-dominant arm at 40 months of age using a 23 gauge 25 mm needle.
This is an open study, so there will be one group only, non-blinded.
Following a blood test on visit 1, participants will receive one booster dose of the 13-valent pneumococcal conjugate vaccine, whatever vaccine they received in the parent study. This will be applied in the non-dominant arm, at a dose of 0.5 ml and as an intramuscular injection. Participants will be monitored for the next 4 days by their parents/legal guardians looking for local/general reactions. A further visit 4 weeks afer vaccination will take place and a blood test will be done then. Pre-school booster vaccines will be offered and administered at this point if they had not received this through their local GP. The study will be finished after this visit. No further follow up will take place.
Intervention type
Drug
Phase
Phase III
Drug names
7-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
Primary outcome measure
To assess the proportion of participants immunised with the 13-valent pneumococcal conjugate vaccine
Secondary outcome measures
1. The PCV13 serotype-specific IgG GMCs, OPA GMTs and proportion of participants with OPA titres = 1:8
2. Rates of local and systemic reactions following vaccination with pre-school PCV13 booster dose at 40
3. PCV13 serotype-specific IgG gemoetric mean concentrations (GMCs), opsonophagocytic activity (OPA)
4. Proportion of participants with PCV13 serotype-specific IgG concentrations = 0.35 mcg/ml at 40 months
Overall trial start date
01/03/2010
Overall trial end date
31/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants must meet the following conditions in order to be enrolled:
1. Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at one of the study sites participating in this follow-on study
2. Aged 39 - 46 months (inclusive) at time of enrolment, either sex
3. Available for entire study period and whose parent/legal guardian can be reached by telephone
4. Healthy children as determined by medical history, 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
5. 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: 100; UK Sample Size: 100
Participant exclusion criteria
Participants with any of the following conditions or characteristics will be excluded from study enrolment:
1. Has received further doses of pneumococcal vaccination with licensed or investigational pneumococcal vaccine other than those given as part of the Wyeth-sponsored PCV13 infant trial study (6096A1-007)
2. A previous anaphylactic reaction to any vaccine or vaccine-related component
3. Contraindication to vaccination with pneumococcal conjugate vaccine
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
5. Known or suspected immune deficiency or suppression
6. History of culture-proven invasive disease caused by S pneumoniae
7. Major known congenital malformation or serious chronic disorder
8. 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
9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies, e.g., synagisB)
10. Participation in another investigational study other than the Wyeth-sponsored PCV13 infant trial study (6096A1-007). Participation in purely observational studies is acceptable.
11. Child who is a direct descendant (child, grandchild) of the study site personnel
Recruitment start date
01/03/2010
Recruitment end date
31/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Vaccine Group, CCVTM
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Organisation
John Radcliffe Hospital (UK)
Sponsor details
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Wyeth Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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