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13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
PCV13
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease focused on measuring 7 valent Pneumococcal conjugate vaccine, 13 valent Pneumococcal conjugate vaccine, PCV13, PCV7

Eligibility Criteria

39 Months - 46 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bristol Children's Vaccine Centre, University of Bristol
  • St George's Vaccine Institute, University of London
  • Oxford Vaccine Group, Dept Paediatrics, University of Oxford
  • Wellcome Trust Clinical Research Facility, University of Southampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PCV13

PCV7

Arm Description

Initial vaccination with PCV13

Initial intervention with PCV7

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
To determine reactogenicity of the pre-school PCV13 booster in terms of rates of local and systemic reactions following vaccination.
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.
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).

Full Information

First Posted
March 26, 2010
Last Updated
March 21, 2011
Sponsor
University of Oxford
Collaborators
University of Bristol, University of Southampton, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT01095471
Brief Title
13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oxford
Collaborators
University of Bristol, University of Southampton, University of London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
Keywords
7 valent Pneumococcal conjugate vaccine, 13 valent Pneumococcal conjugate vaccine, PCV13, PCV7

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCV13
Arm Type
Experimental
Arm Description
Initial vaccination with PCV13
Arm Title
PCV7
Arm Type
Experimental
Arm Description
Initial intervention with PCV7
Intervention Type
Biological
Intervention Name(s)
PCV13
Other Intervention Name(s)
13-valent pneumococcal conjugate vaccine
Intervention Description
Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.
Primary Outcome Measure Information:
Title
To assess the effectiveness of PCV13 booster vaccinations
Description
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).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
To assess IgG concentrations for PCV13 serotypes in children immunised with PCV7 and PCV13
Description
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.
Time Frame
1 month
Title
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.
Time Frame
1 month
Title
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.
Time Frame
1 month
Title
To determine reactogenicity of the pre-school PCV13 booster in terms of rates of local and systemic reactions following vaccination.
Time Frame
1 month
Title
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.
Time Frame
1 month
Title
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).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Months
Maximum Age & Unit of Time
46 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at one of the study sites participating in this follow-on study. Aged 39-46 months (inclusive) at time of enrolment. Available for entire study period and whose parent/legal guardian can be reached by telephone. 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. Parent/legal guardian must be able to complete all relevant study procedures during study participation. Exclusion Criteria: 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). A previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination with pneumococcal conjugate vaccine. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. Known or suspected immune deficiency or suppression. History of culture-proven invasive disease caused by S pneumoniae. Major known congenital malformation or serious chronic disorder. 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. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, synagisB). Participation in another investigational study other than the Wyeth-sponsored PCV13 infant trial study (6096A1-007). Participation in purely observational studies is acceptable. Child who is a direct descendant (child, grandchild) of the study site personnel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Pollard, FRCPCH, PhD
Organizational Affiliation
University of Oxford, Department of Paediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bristol Children's Vaccine Centre, University of Bristol
City
Bristol
Country
United Kingdom
Facility Name
St George's Vaccine Institute, University of London
City
London
Country
United Kingdom
Facility Name
Oxford Vaccine Group, Dept Paediatrics, University of Oxford
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Wellcome Trust Clinical Research Facility, University of Southampton
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28392142
Citation
Truck J, Thompson A, Morales-Aza B, Clutterbuck EA, Voysey M, Clarke E, Snape MD, Kelly DF, Finn A, Pollard AJ. Memory B cell response to a PCV-13 booster in 3.5year old children primed with either PCV-7 or PCV-13. Vaccine. 2017 May 9;35(20):2701-2708. doi: 10.1016/j.vaccine.2017.03.079. Epub 2017 Apr 6.
Results Reference
derived
PubMed Identifier
24618837
Citation
Truck J, Snape MD, Tatangeli F, Voysey M, Yu LM, Faust SN, Heath PT, Finn A, Pollard AJ. Pneumococcal serotype-specific antibodies persist through early childhood after infant immunization: follow-up from a randomized controlled trial. PLoS One. 2014 Mar 11;9(3):e91413. doi: 10.1371/journal.pone.0091413. eCollection 2014.
Results Reference
derived

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13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

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