Condition category
Infections and Infestations
Date applied
04/05/2010
Date assigned
11/06/2010
Last edited
29/08/2013
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

Dr Florencia Tatangeli

ORCID ID

Contact details

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

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 measures

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

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

http://www.oxfordradcliffe.nhs.uk/aboutus/hospitals/jr.aspx

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes