13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

Pneumococcal Disease Clinical Trial

Official title:

A follow-on, Multi-centre, Open-label, Clinical, Phase 4 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095471
• Other study ID #: 2009/04
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2010
• Last updated: March 21, 2011
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a follow-on, multi-centre, open-label, clinical trial. The purpose of this trial is to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in children who have received either the PCV7 or PCV13 primary immunisation at 2, 4 and 12 months of age. We intend to recruit all interested participants who completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e. those that recruited the majority of the children in the original study). The study will start in March 2010, at which time the eldest participants in the 6096A1-007 study will be approximately 42 months of age. There will be two visits per participant, 1 month apart from each other. At visit one, all participants will have a blood test and receive a dose of PCV13. At visit 2, all participants will have a blood test and will be offered the remaining pre-school booster vaccinations unless they have already received them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 39 Months to 46 Months

Eligibility

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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; eg, 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Disease

Intervention

Biological:
• PCV13
Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.

Locations

Country	Name	City	State
United Kingdom	Bristol Children's Vaccine Centre, University of Bristol	Bristol
United Kingdom	St George's Vaccine Institute, University of London	London
United Kingdom	Oxford Vaccine Group, Dept Paediatrics, University of Oxford	Oxford
United Kingdom	Wellcome Trust Clinical Research Facility, University of Southampton	Southampton

Sponsors (4)

Lead Sponsor	Collaborator
University of Oxford	University of Bristol, University of London, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effectiveness of PCV13 booster vaccinations	To assess the proportion of participants, immunised with the 13-valent pneumococcal conjugate vaccine (PCV13) at 2, 4 and 12 months of age, who have IgG concentrations = 0.35mcg/ml for PCV13 serotypes at the time when preschool booster vaccinations are due (at 40 months of age).	1 month	No
Secondary	To assess IgG concentrations for PCV13 serotypes in children immunised with PCV7 and PCV13	To assess the proportion of participants, immunised with the 7-valent pneumococcal conjugate vaccine (PCV7) at 2, 4 and 12 months of age, who have IgG concentrations = 0.35mcg/ml for PCV13 serotypes at the time when preschool booster vaccinations are due (at 40 months of age) and comparing these to the proportion of participants achieving this threshold after infant immunisation with PCV 13.	1 month	No
Secondary	Compare PCV13 serotype-specific IgG geometric mean concentrations, opsonophagocytic activity geometric mean titres & the proportion of participants with PCV13 serotype-specific OPA titres = 1:8 (at 40 months) when immunised in infancy with PCV7 or PCV13.		1 month	No
Secondary	Compare PCV serotype-specific IgG GMCs, OPA GMTs & proportion of participants with IgG concs = 0.35mcg/ml & OPA titres = 1:8 one month after booster dose of PCV13 at 40 months in children previously immunised with PCV7 & PCV13 at 2,4 & 12 months.		1 month	No
Secondary	To determine reactogenicity of the pre-school PCV13 booster in terms of rates of local and systemic reactions following vaccination.		1 month	No
Secondary	Investigate influence of genetic polymorphisms on the above immunological markers following infant immunisation with PCV7/PCV13 & following booster dose of PCV13 at 40 months & on the nature of adverse reactions observed after booster.		1 month	No
Secondary	Measure pneumococcal serotype-specific memory B cells frequencies before & 1 month after PCV13 dose (40 months) in subset previously immunised with PCV7/PCV13 at 2,4 & 12 months (serotype studies to include 4,14,23F (present in PCV7) & 1,3,19A).		1 month	No