Broader Protection Against Pneumococcal Disease

ISRCTN ISRCTN21841117
DOI https://doi.org/10.1186/ISRCTN21841117
Protocol serial number 8092
Sponsor John Radcliffe Hospital (UK)
Funder Wyeth Pharmaceuticals (UK)
Submission date
04/05/2010
Registration date
11/06/2010
Last edited
29/08/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Florencia Tatangeli
Scientific

Oxford Vaccine Group, CCVTM
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Study information

Primary study designInterventional
Study designNon-randomised interventional prevention trial
Secondary study designNon randomised controlled trial
Study type Participant information sheet
Scientific titleA 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
Study objectives1. 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(s)Oxfordshire REC C approved on the 18/03/2010 (ref: 10/H0606/9)
Health condition(s) or problem(s) studiedTopic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
InterventionStudy 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 typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)7-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
Primary outcome measure(s)

To assess the proportion of participants immunised with the 13-valent pneumococcal conjugate vaccine

Key secondary outcome measure(s)

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

Completion date31/03/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit39 Months
Upper age limit46 Months
SexAll
Target sample size at registration100
Key inclusion criteriaParticipants 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
Key exclusion criteriaParticipants 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
Date of first enrolment01/03/2010
Date of final enrolment31/03/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Oxford Vaccine Group, CCVTM
Oxford
OX3 7LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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